Vascular Health With Immobilization and Exercise Training

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054376
• Other study ID #: ANG-CV- IMMOB
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: October 20, 2022

Study information

• Verified date: November 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Immobilization, Tonic
• Physical Activity

Intervention

Other:
• Immobilization
Full length cast of one leg R/L randomized
• Training with non immobilized leg
Exercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks
• Exercise training with both legs
Exercise training will be conducted regularly on a cycle ergometer during a four week period

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
University of Copenhagen	Johannes Gutenberg University Mainz, Liverpool John Moores University, Radboud University Medical Center, University of Leeds

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiogenesis	Skeletal muscle capillarization-comparison between legs	Change from baseline to after 2 weeks of immobilization
Primary	Vascular function	Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs	Change from baseline to after 2 weeks of immobilization
Primary	Angiogenesis	Skeletal muscle capillarization-comparison between legs	Change from after immobilization to after 4 weeks of training
Primary	Vascular function	Measurements of skeletal muscle blood flow by ultrasound doppler in response to infusion of vasodilators/constrictors-comparison between legs	Change from after immobilization to after 4 weeks of training
Secondary	Vascular and metabolic proteins	Proteins of importance for vascular function and muscle metabolism measured in muscle biopsy samples, skeletal muscle interstitial fluid and plasma-comparison between legs	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Arterial blood pressure	Measured by sphygmomanometer and intra-arterially	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Knee extensor performance	Measurements of maximal power and endurance-comparison between legs	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Maximal oxygen uptake	Measured by gas analysis during an incremental ergometer cycle protocol	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Body composition	Measurements by dual energy x-ray absorptiometry	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Skin microcirculation	Measurements of skin blood flow and morphology and relevant proteins in skin biopsies	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Markers of bone metabolism	Measurements of bone markers in plasma	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Markers of angiogenesis	Measurement of angiogenic and apoptotic factors-comparison between legs	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Secondary	Vascular function-non-invasive	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	Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training