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    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
    EudraCT number
    		 2023-000150-20
    Trial protocol
    		 DK  
    Global end of trial date
    13 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2024
    First version publication date
    17 Aug 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06174961
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Department of Clinical Pharmacology, Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, +45 38635102, kristian.karstoft.01@regionh.dk
    Scientific contact
    Department of Clinical Pharmacology, Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, +45 38635102, kristian.karstoft.01@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potential participants were recruited through direct contact, advertising on "www.forskningnu.dk"

    Pre-assignment
    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
    Period 1 title
    No exercise vs Double-legged exercise
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for cutaneous solution, Solution for injection in vial
    Routes of administration
    Subcutaneous use
    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

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial, Concentrate and solvent for cutaneous solution
    Routes of administration
    Subcutaneous use
    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

    Number of subjects in period 1
    		No exercise Double-legged exercise
    Started
    7
    8
    Completed
    7
    8
    Period 2
    Period 2 title
    Dominant leg vs. Non-dominant leg
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for cutaneous solution, Solution for injection in vial
    Routes of administration
    Subcutaneous use
    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

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for cutaneous solution, Solution for injection in vial
    Routes of administration
    Subcutaneous use
    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

    Number of subjects in period 2
    		Non-dominant leg Dominant leg
    Started
    8
    7
    Completed
    8
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    No exercise vs Double-legged exercise
    Reporting group description
    		 -

    Reporting group values
    		 No exercise vs Double-legged exercise Total
    Number of subjects
    		 15 15
    Age categorical
    All participants were between 18 and 50 years old
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 15 15
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28 ( 4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 15 15
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 186 ( 5 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 81 ( 8 ) -
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 23.4 ( 1.4 ) -
    Maximal heart rate
    Units: beats per minute (bpm)
        arithmetic mean (standard deviation)
    		 185 ( 17 ) -
    Maximal Watt
    Units: watt
        arithmetic mean (standard deviation)
    		 305 ( 36 ) -
    Average systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 124 ( 9 ) -
    Average diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 72 ( 8 ) -
    P-antitrombin
    Units: kIU/L
        arithmetic mean (standard deviation)
    		 1.02 ( 0.08 ) -

    End points

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    End points reporting groups
    Reporting group title
    No exercise
    Reporting group description
    		 Inactive in supine position for 1 hour after receiving UFH in the non-dominant leg.

    Reporting group title
    Double-legged exercise
    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
    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
    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.

    Primary: Change in aPTT

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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.
    End point type
    Primary
    End point timeframe
    Change in aPTT measured as maximum aPTT (during the 8 hours after injection of UFH) minus baseline aPTT.
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: second
        arithmetic mean (confidence interval 95%)
    7.9 (3.5 to 12.3)
    8.7 (4.2 to 13.2)
    16.5 (5.2 to 27.8)
    13.1 (0.3 to 26.0)
    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 [1]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.
    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 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.

    Secondary: Change in plasma heparin

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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.
    End point type
    Secondary
    End point timeframe
    Change in plasma heparin measured as maximum aPTT (during the 8 hours after injection of UFH) minus baseline plasma heparin.
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: kIU/L
        arithmetic mean (confidence interval 95%)
    0.16 (0.12 to 0.19)
    0.18 (0.12 to 0.23)
    0.23 (0.15 to 0.31)
    0.19 (0.12 to 0.27)
    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
    Double-legged exercise v No exercise
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.
    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 [4]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.

    Other pre-specified: Mean incremental aPTT

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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)
    End point type
    Other pre-specified
    End point timeframe
    Mean incremental aPTT during the entire experimental day (ending 8 hours after UFH injection)
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: second
        arithmetic mean (confidence interval 95%)
    2.1 (-1.6 to 5.8)
    1.3 (-1.3 to 3.9)
    6.4 (-0.1 to 12.8)
    4.5 (-2.8 to 11.8)
    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 [5]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.
    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 [6]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.

    Other pre-specified: Mean incremental plasma heparin

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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)
    End point type
    Other pre-specified
    End point timeframe
    Mean incremental plasma heparin during the entire experimental day (ending 8 hours after UFH injection)
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: kIU/L
        arithmetic mean (confidence interval 95%)
    0.11 (0.07 to 0.14)
    0.11 (0.07 to 0.15)
    0.14 (0.09 to 0.20)
    0.13 (0.07 to 0.19)
    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 [7]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.
    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 [8]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         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.

    Other pre-specified: Change in aPTT at t240

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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
    End point type
    Other pre-specified
    End point timeframe
    apTT level 240 minutes after UFH injection minus apTT level at baseline
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: second
        arithmetic mean (confidence interval 95%)
    4.6 (-0.6 to 9.9)
    3.8 (0.4 to 7.1)
    13.1 (3.0 to 23.2)
    10.9 (-2.5 to 24.2)
    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.

    Other pre-specified: Change in plasma heparin at t240

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    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
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: kIU/L
        arithmetic mean (confidence interval 95%)
    0.13 (0.09 to 0.17)
    0.13 (0.08 to 0.17)
    0.18 (0.10 to 0.26)
    0.18 (0.09 to 0.26)
    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.

    Post-hoc: Change in aPTT at t60

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    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
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: second
        arithmetic mean (confidence interval 95%)
    1.9 (-0.5 to 4.4)
    5.0 (0.3 to 9.8)
    6.7 (-0.8 to 14.3)
    -3.0 (-5.1 to 0.8)
    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.

    Post-hoc: Change in plasma heparin at t60

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    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
    End point values
    		 No exercise Double-legged exercise Non-dominant leg Dominant leg
    Number of subjects analysed
    7
    8
    8
    7
    Units: kIU/L
        arithmetic mean (confidence interval 95%)
    0.08 (0.06 to 0.10)
    0.15 (0.09 to 0.21)
    0.16 (0.09 to 0.23)
    0.05 (0.03 to 0.08)
    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

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    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
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    Vascular disorders
    Syncope
    Additional description: One individual had a vasovagal syncope and fainted in relation to his venous catheter being adjusted
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Haematoma
    Additional description: One individual experienced a hematoma in relation to where his venous catheter had been located
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
    Additional description: 3 individuals experienced mild muscle soreness in relation to experimental days involving exercise
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3

    More information

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    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
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