Clinical Trial Results:
The effect of exercise on pharmacodynamics and pharmacokinetics of a single dose of unfractionated heparin: A randomized, controlled, cross-over study
Summary
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EudraCT number |
2023-000150-20 |
Trial protocol |
DK |
Global end of trial date |
13 Feb 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Aug 2024
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First version publication date |
17 Aug 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT06174961 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital
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Sponsor organisation address |
Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
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Public contact |
Department of Clinical Pharmacology, Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, +45 38635102, kristian.karstoft.01@regionh.dk
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Scientific contact |
Department of Clinical Pharmacology, Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, +45 38635102, kristian.karstoft.01@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 May 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Feb 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Feb 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the effect of a single exercise session (with both legs) on pharmacodynamics and pharmacokinetics of a single dose of subcutaneously administered unfractionated heparin.
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Protection of trial subjects |
WattMAX test: A physical fitness test, where subjects must put in maximum effort. This will cause some degree of breathlessness. No risks are anticipated.
Blood sampling: Will cause minor discomfort in terms of a venous catheter. Theoretically, there is a risk for infections and superficial venous thromboses introduced via the catheter. This risk is minimized by use of aseptic technique and by continuous inflow of saline and. The blood volume collected is so small that it will cause no symptoms.
UFH treatment: Common side effects of UFH treatment include short-lasting increased bleeding tendency, local hematomas and injection site reactions (5). Rarely, UFH leads to thrombocytopenia (heparin induced thrombocytopenia – HIT), and very rarely, these cases are severe due to autoimmunicity leading to thromboembolic complications and massive bleeding tendency (16). The risk of HIT is largest in individuals who get heparins on a regular basis, meaning that the risk in the current study, where subjects will only get four UFH injections in total, is considered to be very small. Subjects will be informed about the risk of HIT and typical signs of this and will be instructed to contact the investigator immediately in case of symptoms on HIT.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
15
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Potential participants were recruited through direct contact, advertising on "www.forskningnu.dk" | |||||||||
Pre-assignment
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Screening details |
A medical examination, medical history, blood chemistry screen (hematology incl. coagulation markers, liver and kidney markers (incl. potassium)), and a physical fitness test (WattMAX test) was performed. In addition to this, information about the overall study plan and experimental days was provided to the participant. | |||||||||
Period 1
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Period 1 title |
No exercise vs Double-legged exercise
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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No exercise | |||||||||
Arm description |
Inactive in supine position for 1 hour after receiving UFH in the non-dominant leg. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Unfractionated Heparin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for cutaneous solution, Solution for injection in vial
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
15.000 IU UFH (Heparin ‘LEO’, 5000 IE/ml, 5 ml per vial) was injected subcutaneously in the thigh in 3 separate injections (1 ml per injection). All injections of UFH was performed in the non-dominant leg
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Arm title
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Double-legged exercise | |||||||||
Arm description |
Double-legged exercise for 1 hour after receiving UFH in the non-dominant leg. Exercise was initiated at 40% of WattMax and continously adjusted, aiming for a RPE of 12-13. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Unfractionated Heparin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in vial, Concentrate and solvent for cutaneous solution
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
15.000 IU UFH (Heparin ‘LEO’, 5000 IE/ml, 5 ml per vial) was injected subcutaneously in the thigh in 3 separate injections (1 ml per injection). All injections of UFH was performed in the non-dominant leg
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Period 2
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Period 2 title |
Dominant leg vs. Non-dominant leg
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Non-dominant leg | |||||||||
Arm description |
Exercise with non-dominant leg for 1 hour after receiving UFH in the non-dominant leg. Exercise was initiated at 50% of what was performed on the double-legged exercise experimental day and continously adjusted, aiming for a RPE of 12-13. The two experimental days with single-legged exercise interventions was matched with regards to exercise intensity. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Unfractionated Heparin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for cutaneous solution, Solution for injection in vial
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
15.000 IU UFH (Heparin ‘LEO’, 5000 IE/ml, 5 ml per vial) was injected subcutaneously in the thigh in 3 separate injections (1 ml per injection). All injections of UFH was performed in the non-dominant leg
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Arm title
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Dominant leg | |||||||||
Arm description |
Exercise with dominant leg for 1 hour after receiving UFH in the non-dominant leg. Exercise was initiated at 50% of what was performed on the double-legged exercise experimental day and continously adjusted, aiming for a RPE of 12-13. The two experimental days with single-legged exercise interventions was matched with regards to exercise intensity. | |||||||||
Arm type |
Comparative | |||||||||
Investigational medicinal product name |
Unfractionated Heparin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for cutaneous solution, Solution for injection in vial
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
15.000 IU UFH (Heparin ‘LEO’, 5000 IE/ml, 5 ml per vial) was injected subcutaneously in the thigh in 3 separate injections (1 ml per injection). All injections of UFH was performed in the non-dominant leg
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Baseline characteristics reporting groups
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Reporting group title |
No exercise vs Double-legged exercise
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
No exercise
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Reporting group description |
Inactive in supine position for 1 hour after receiving UFH in the non-dominant leg. | ||
Reporting group title |
Double-legged exercise
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Reporting group description |
Double-legged exercise for 1 hour after receiving UFH in the non-dominant leg. Exercise was initiated at 40% of WattMax and continously adjusted, aiming for a RPE of 12-13. | ||
Reporting group title |
Non-dominant leg
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Reporting group description |
Exercise with non-dominant leg for 1 hour after receiving UFH in the non-dominant leg. Exercise was initiated at 50% of what was performed on the double-legged exercise experimental day and continously adjusted, aiming for a RPE of 12-13. The two experimental days with single-legged exercise interventions was matched with regards to exercise intensity. | ||
Reporting group title |
Dominant leg
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Reporting group description |
Exercise with dominant leg for 1 hour after receiving UFH in the non-dominant leg. Exercise was initiated at 50% of what was performed on the double-legged exercise experimental day and continously adjusted, aiming for a RPE of 12-13. The two experimental days with single-legged exercise interventions was matched with regards to exercise intensity. |
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End point title |
Change in aPTT | ||||||||||||||||||||
End point description |
Change in aPTT measured as maximum aPTT (during the 8 hours after injection of UFH) minus baseline aPTT.
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End point type |
Primary
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End point timeframe |
Change in aPTT measured as maximum aPTT (during the 8 hours after injection of UFH) minus baseline aPTT.
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
No exercise v Double-legged exercise
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0.8
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-3 | ||||||||||||||||||||
upper limit |
4.5 | ||||||||||||||||||||
Notes [1] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
Non-dominant leg v Dominant leg
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
3.4
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-2.1 | ||||||||||||||||||||
upper limit |
8.8 | ||||||||||||||||||||
Notes [2] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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End point title |
Change in plasma heparin | ||||||||||||||||||||
End point description |
Change in plasma heparin measured as maximum aPTT (during the 8 hours after injection of UFH) minus baseline plasma heparin.
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End point type |
Secondary
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End point timeframe |
Change in plasma heparin measured as maximum aPTT (during the 8 hours after injection of UFH) minus baseline plasma heparin.
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
Double-legged exercise v No exercise
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0.02
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.03 | ||||||||||||||||||||
upper limit |
0.07 | ||||||||||||||||||||
Notes [3] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
Non-dominant leg v Dominant leg
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [4] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0.23
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
0.15 | ||||||||||||||||||||
upper limit |
0.31 | ||||||||||||||||||||
Notes [4] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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End point title |
Mean incremental aPTT | ||||||||||||||||||||
End point description |
Mean incremental aPTT during the entire experimental day (ending 8 hours after UFH injection)
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End point type |
Other pre-specified
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End point timeframe |
Mean incremental aPTT during the entire experimental day (ending 8 hours after UFH injection)
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
No exercise v Double-legged exercise
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [5] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||||||||||
Point estimate |
0.7
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-3.8 | ||||||||||||||||||||
upper limit |
2.3 | ||||||||||||||||||||
Notes [5] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
Non-dominant leg v Dominant leg
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [6] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
6.4
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.1 | ||||||||||||||||||||
upper limit |
12.8 | ||||||||||||||||||||
Notes [6] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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End point title |
Mean incremental plasma heparin | ||||||||||||||||||||
End point description |
Mean incremental plasma heparin during the entire experimental day (ending 8 hours after UFH injection)
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End point type |
Other pre-specified
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End point timeframe |
Mean incremental plasma heparin during the entire experimental day (ending 8 hours after UFH injection)
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
No exercise v Double-legged exercise
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [7] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.03 | ||||||||||||||||||||
upper limit |
0.03 | ||||||||||||||||||||
Notes [7] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
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Comparison groups |
Non-dominant leg v Dominant leg
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Number of subjects included in analysis |
15
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Analysis specification |
Pre-specified
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Analysis type |
other [8] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0.01
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Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.06 | ||||||||||||||||||||
upper limit |
0.03 | ||||||||||||||||||||
Notes [8] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
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End point title |
Change in aPTT at t240 | ||||||||||||||||||||
End point description |
apTT level 240 minutes after UFH injection minus apTT level at baseline
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End point type |
Other pre-specified
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End point timeframe |
apTT level 240 minutes after UFH injection minus apTT level at baseline
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Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
No exercise v Double-legged exercise
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other [9] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
-0.8
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-5.9 | ||||||||||||||||||||
upper limit |
4.4 | ||||||||||||||||||||
Notes [9] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
Non-dominant leg v Dominant leg
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other [10] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
2.2
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-3.5 | ||||||||||||||||||||
upper limit |
8 | ||||||||||||||||||||
Notes [10] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|
|||||||||||||||||||||
End point title |
Change in plasma heparin at t240 | ||||||||||||||||||||
End point description |
plasma heparin level 240 minutes after UFH injection minus plasma heparin level at baseline
|
||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||
End point timeframe |
plasma heparin level 240 minutes after UFH injection minus plasma heparin level at baseline
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
No exercise v Double-legged exercise
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other [11] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-0.05 | ||||||||||||||||||||
upper limit |
0.04 | ||||||||||||||||||||
Notes [11] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
Non-dominant leg v Dominant leg
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
other [12] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
-0.07 | ||||||||||||||||||||
upper limit |
0.07 | ||||||||||||||||||||
Notes [12] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|
|||||||||||||||||||||
End point title |
Change in aPTT at t60 | ||||||||||||||||||||
End point description |
aPTT level 60 minutes after UFH injection minus plasma aPTT level at baseline
|
||||||||||||||||||||
End point type |
Post-hoc
|
||||||||||||||||||||
End point timeframe |
aPTT level 60 minutes after UFH injection minus plasma aPTT level at baseline
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
No exercise v Double-legged exercise
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||||||||||
Analysis type |
other [13] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
3.1
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
0 | ||||||||||||||||||||
upper limit |
6.2 | ||||||||||||||||||||
Notes [13] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
Non-dominant leg v Dominant leg
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||||||||||
Analysis type |
other [14] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
9.7
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
3.9 | ||||||||||||||||||||
upper limit |
15.5 | ||||||||||||||||||||
Notes [14] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|
|||||||||||||||||||||
End point title |
Change in plasma heparin at t60 | ||||||||||||||||||||
End point description |
plasma heparin level 60 minutes after UFH injection minus plasma heparin level at baseline
|
||||||||||||||||||||
End point type |
Post-hoc
|
||||||||||||||||||||
End point timeframe |
plasma heparin level 60 minutes after UFH injection minus plasma heparin level at baseline
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
No exercise v Double-legged exercise
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||||||||||
Analysis type |
other [15] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0.08
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
0.02 | ||||||||||||||||||||
upper limit |
0.13 | ||||||||||||||||||||
Notes [15] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|||||||||||||||||||||
Statistical analysis title |
Paired two tailed t-test | ||||||||||||||||||||
Statistical analysis description |
A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention.
|
||||||||||||||||||||
Comparison groups |
Non-dominant leg v Dominant leg
|
||||||||||||||||||||
Number of subjects included in analysis |
15
|
||||||||||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||||||||||
Analysis type |
other [16] | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||||||
Point estimate |
0.11
|
||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||
lower limit |
0.05 | ||||||||||||||||||||
upper limit |
0.16 | ||||||||||||||||||||
Notes [16] - A paired two tailed t-test was conducted. The "No exercise" intervention was compared to the "double-legged exercise" intervention, while the "exercise with dominant-leg" intervention was compared to the "exercise with non-dominant leg" intervention. |
|
|||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
All AEs are registered in the electronic CRF at the end of the intervention days and one week after each intervention day.
|
||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||
Dictionary name |
ICH GCP | ||||||||||||||||||||||||||||||||||||
Dictionary version |
R1
|
||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||
Reporting group title |
All participants
|
||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |