Vascular Health With Immobilization and Exercise Training

NCT ID: NCT03054376

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2022-10-20

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.

Conditions

Immobilization, Tonic; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Immobilization

Intervention Type: OTHER

Full length cast of one leg R/L randomized

Exercise training with both legs

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Immobilization

Intervention Type: OTHER

Full length cast of one leg R/L randomized

Training with non immobilized leg

Intervention Type: OTHER

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

Exercise training with both legs

Intervention Type: OTHER

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

Interventions

Immobilization

Full length cast of one leg R/L randomized

Intervention Type: OTHER

Training with non immobilized leg

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

Intervention Type: OTHER

Exercise training with both legs

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: collaborator

Liverpool John Moores University

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Ylva Hellsten

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 33787530 (View on PubMed)

Other Identifiers

ANG-CV- IMMOB

Identifier Type: -

Identifier Source: org_study_id