Vascular Health With Immobilization and Exercise Training
Impact of Training on Skeletal Muscle Vascular and Metabolic Changes With Limb Immobilization
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedNovember 2, 2022
November 1, 2022
5.6 years
February 5, 2017
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Angiogenesis
Skeletal muscle capillarization-comparison between legs
Change from baseline to after 2 weeks of immobilization
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
Angiogenesis
Skeletal muscle capillarization-comparison between legs
Change from after immobilization to after 4 weeks of training
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 Outcomes (9)
Vascular and metabolic proteins
Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Arterial blood pressure
Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Knee extensor performance
Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Maximal oxygen uptake
Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
Body composition
Change from baseline to after 2 weeks of immobilization and from after immobilization to after 4 weeks of training
- +4 more secondary outcomes
Study Arms (2)
Immobilization
ACTIVE COMPARATORAfter 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.
Training of non-immobilized leg
ACTIVE COMPARATORAfter 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.
Interventions
Full length cast of one leg R/L randomized
Exercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks
Exercise training will be conducted regularly on a cycle ergometer during a four week period
Eligibility Criteria
You may qualify if:
- Healthy
- BMI \<25
- Habitually/moderately physically active
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Johannes Gutenberg University Mainzcollaborator
- University of Leedscollaborator
- Liverpool John Moores Universitycollaborator
- Radboud University Medical Centercollaborator
Study Sites (1)
University of Copenhagen
Copenhagen, Denmark
Related Publications (1)
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.
PMID: 33787530DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 5, 2017
First Posted
February 15, 2017
Study Start
March 15, 2017
Primary Completion
October 20, 2022
Study Completion
October 20, 2022
Last Updated
November 2, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share