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Completed

NCT Number: NCT03054376

Vascular Health With Immobilization and Exercise Training

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.

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Key information

Conditions

Immobilization, Tonic Behavior Behavior, Animal Immobility Response, Tonic Motor Activity Physical Activity

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immobilization

Other

Full length cast of one leg R/L randomized

Training with non immobilized leg

Other

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

Exercise training with both legs

Other

Exercise training will be conducted regularly on a cycle ergometer during a four week period

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Johannes Gutenberg University Mainz
  • Liverpool John Moores University
  • Radboud University Medical Center
  • University of Leeds

Registry information

Official study title

Impact of Training on Skeletal Muscle Vascular and Metabolic Changes With Limb Immobilization

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2017
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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