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Vascular Health With Immobilization and Exercise Training

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ClinicalTrials.gov Identifier: NCT03054376
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
Johannes Gutenberg University Mainz
University of Leeds
Liverpool John Moores University
Radboud University
Information provided by (Responsible Party):
Ylva Hellsten, University of Copenhagen

Brief Summary:
The study includes healthy young habitually active subjects. All subjects are subjected to two weeks of immobilization of one leg followed by four weeks of training of both legs. The subjects are randomized to either one-leg training of the non-immobilized leg during the two-week immobilization period or to no training of the non-immobilized leg during the immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis and apoptosis, muscle metabolic markers, vascular function, vascular proteins and performance.

Condition or disease Intervention/treatment Phase
Immobilization, Tonic Physical Activity Other: Immobilization Other: Training with non immobilized leg Other: Exercise training with both legs Not Applicable

Detailed Description:
One leg of young healthy subjects will be immoblized for two weeks. Changes in angiogenic proteins and markers of apoptosis in muscle tissue and muscle extracellular fluid will be determined in both legs and in parallel the functional consequences of immobilization will be assessed. Vascular function and vascular proteins will also be determined. In order to understand how the oxidative capacity of the muscle is altered in parallel with changes in capillarization, markers of mitochondria will be measured .Half of the subjects will be randomized to single-leg training during the immobilization period to assess whether simultaneous training reduces the loss of capillaries, muscle function and vascular function in the immobilized leg. After the immobilization period the study participants will train the immobilized leg and the control leg for four weeks by moderate to intense interval cycle training and the same parameteres as during immobilization will be assessed in both legs. The study will also include measurements of circulating compounds and platelets in blood.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized to training or no training of non-immobilized leg during immobilization of the other leg
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Training on Skeletal Muscle Vascular and Metabolic Changes With Limb Immobilization
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : October 20, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Immobilization
After baseline studies, the subjects will have one leg immobilized by full length plaster for two weeks. During the two weeks, the other leg will not be trained. After the two weeks the subjects will train both legs for four weeks.
Other: Immobilization
Full length cast of one leg R/L randomized

Other: Exercise training with both legs
Exercise training will be conducted regularly on a cycle ergometer during a four week period

Active Comparator: Training of non-immobilized leg
After baseline studies, the subjects will have one leg immobilized by full length plaster for two weeks. During the two weeks, the other leg will be trained. After the two weeks the subjects will train both legs for four weeks.
Other: Immobilization
Full length cast of one leg R/L randomized

Other: Training with non immobilized leg
Exercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks

Other: Exercise training with both legs
Exercise training will be conducted regularly on a cycle ergometer during a four week period




Primary Outcome Measures :
  1. Angiogenesis [ Time Frame: Change from baseline to after 2 weeks of immobilization ]
    Skeletal muscle capillarization-comparison between legs

  2. Vascular function [ Time Frame: Change from baseline to after 2 weeks of immobilization ]
    Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs

  3. Angiogenesis [ Time Frame: Change from after immobilization to after 4 weeks of training ]
    Skeletal muscle capillarization-comparison between legs

  4. Vascular function [ Time Frame: Change from after immobilization to after 4 weeks of training ]
    Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs


Secondary Outcome Measures :
  1. Vascular and metabolic proteins [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Proteins of importance for vascular function and muscle metabolism measured in muscle biopsy samples, skeletal muscle interstitial fluid and plasma-comparison between legs

  2. Arterial blood pressure [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measured by sphygmomanometer and intra-arterially

  3. Knee extensor performance [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measurements of maximal power and endurance-comparison between legs

  4. Maximal oxygen uptake [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measured by gas analysis during an incremental ergometer cycle protocol

  5. Body composition [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measurements by dual energy x-ray absorptiometry

  6. Skin microcirculation [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measurements of skin blood flow and morphology and relevant proteins in skin biopsies

  7. Markers of bone metabolism [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measurements of bone markers in plasma

  8. Markers of angiogenesis [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measurement of angiogenic and apoptotic factors-comparison between legs

  9. Vascular function-non-invasive [ Time Frame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training ]
    Measurements of skeletal muscle blood flow at rest, during passive movement, during exercise, after five min of occlusion and during infusion of vasodilators and constrictors-comparison between legs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • BMI <25
  • Habitually/moderately physically active

Exclusion Criteria:

  • Known chronic medical disorder
  • Smoking
  • Excessive alcohol intake
  • Known genetic/familial predisposition for thrombosis
  • Hormonal birth control
  • High level strength or endurance training on a regular basis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054376


Locations
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Denmark
University of Copenhagen
Copenhagen, Denmark
Sponsors and Collaborators
University of Copenhagen
Johannes Gutenberg University Mainz
University of Leeds
Liverpool John Moores University
Radboud University
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Responsible Party: Ylva Hellsten, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03054376    
Other Study ID Numbers: ANG-CV- IMMOB
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ylva Hellsten, University of Copenhagen:
Immobilization
Angiogenesis
Skeletal muscle
Exercise training
Vascular function