NCT03054376

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

5.6 years

First QC Date

February 5, 2017

Last Update Submit

November 1, 2022

Conditions

Keywords

ImmobilizationAngiogenesisSkeletal muscleExercise trainingVascular function

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 COMPARATOR

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.

Other: ImmobilizationOther: Exercise training with both legs

Training of non-immobilized leg

ACTIVE COMPARATOR

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.

Other: ImmobilizationOther: Training with non immobilized legOther: Exercise training with both legs

Interventions

Full length cast of one leg R/L randomized

ImmobilizationTraining of non-immobilized leg

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

Training of non-immobilized leg

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

ImmobilizationTraining of non-immobilized leg

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

Location

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.

MeSH Terms

Conditions

Immobility Response, TonicMotor Activity

Interventions

ImmobilizationExercise

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel randomized to training or no training of non-immobilized leg during immobilization of the other leg
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

Locations