Clinical trial NCT03054376: Vascular Health With Immobilization and Exercise Training
Official title: Impact of Training on Skeletal Muscle Vascular and Metabolic Changes With Limb Immobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immobilization, Tonic
Physical Activity
Keywords: Immobilization
Angiogenesis
Skeletal muscle
Exercise training
Vascular function
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
name: University of Leeds
name: Liverpool John Moores University
name: Radboud University Medical Center
First posted: 2017-02-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized to training or no training of non-immobilized leg during immobilization of the other leg
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Angiogenesis
timeFrame: Change from baseline to after 2 weeks of immobilization
measure: Vascular function
timeFrame: Change from baseline to after 2 weeks of immobilization
measure: Angiogenesis
timeFrame: Change from after immobilization to after 4 weeks of training
measure: Vascular function
timeFrame: Change from after immobilization to after 4 weeks of training
Secondary outcomes:
measure: Vascular and metabolic proteins
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Arterial blood pressure
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Knee extensor performance
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Maximal oxygen uptake
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Body composition
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Skin microcirculation
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Markers of bone metabolism
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Markers of angiogenesis
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
measure: Vascular function-non-invasive
timeFrame: Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
citation: Gliemann L, Rytter N, Jorgensen TS, Piil P, Carter H, Nyberg M, Grassi M, Daumer M, Hellsten Y. The Impact of Lower Limb Immobilization and Rehabilitation on Angiogenic Proteins and Capillarization in Skeletal Muscle. Med Sci Sports Exerc. 2021 Sep 1;53(9):1797-1806. doi: 10.1249/MSS.0000000000002665.