NCT03046095

Brief Summary

It is well known that periods of weight training lead to increases in skeletal muscle size and strength. In contrast, periods of inactivity such as bed rest or immobilization result in losses of skeletal muscle size and strength. However, individuals experience variable magnitudes of muscle size change in response to changes in mechanical tension, such that certain individuals experience large changes in muscle mass whereas others do not. What is not currently known, and will be the primary goal of the present investigation, is to determine whether individuals who gain the most muscle mass with exercise training also lose the most muscle when they are immobilized. The investigators hypothesize that individuals who gain the most muscle with training will also lose the most with immobilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

February 2, 2017

Last Update Submit

June 17, 2019

Conditions

Keywords

Muscle HypertrophyMuscle AtrophyResistance TrainingImmobilization

Outcome Measures

Primary Outcomes (2)

  • Muscle Cross Sectional Area

    The changes in muscle cross sectional area will be assessed pre-training (week 0) and post training/immobilization (week 10) using magnetic resonance imaging (MRI). Muscle cross-sectional area will be assessed over a continuous period of 7 months.

    May 2017 - Dec 2017

  • Leg Lean Mass

    The changes in leg lean mass will be assessed pre-training (week 0) and post-training/immobilization using dual energy x-ray absorptiometry. Leg lean mass measurements will be made over a continuous period of 7 months.

    May 2017 - Dec 2017

Secondary Outcomes (1)

  • Skeletal Muscle Gene Expression

    May 2017 - Dec 2017

Study Arms (2)

Unilateral Resistance Exercise

EXPERIMENTAL

One of the participant's legs will be randomized to a unilateral resistance training arm for 10 weeks in duration. The leg chosen to be trained will undergo resistance exercise three days per week (Monday, Wednesday, and Friday) for the entirety of the study.

Other: Unilateral Resistance Exercise

Immobilization

EXPERIMENTAL

One of the participant's legs will be chosen to be immobilized during the last two weeks of the study. Therefore, one leg will be resistance exercising from week 0-10 whereas the other leg will be immobilized during weeks 8-10.

Procedure: Immobilization

Interventions

Unilateral Resistance exercise will include training three days per week and each session will include 3 sets of leg extension and 3 sets of leg press. In each set, the participant will complete a maximum of 12 repetitions.

Also known as: Resistance training
Unilateral Resistance Exercise

During the last two weeks of the study (week 8-10), a Don Joy adjustable knee brace will be applied to the participant's leg randomized to immobilization. The brace will be applied at a 40 degree angle relative to complete extension.

Also known as: Knee Bracing
Immobilization

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-Smoker
  • Do not heavily consume alcohol

You may not qualify if:

  • Female
  • Younger than 18, or older than 30 years
  • use of anti-inflammatory or analgesic medication
  • history of neuromuscular disorders
  • family history of deep vein thrombosis
  • regularly take part in structured physical exercise (greater than 2 days per week)
  • take any medications known to influence protein metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Muscular AtrophyMuscular Disorders, Atrophic

Interventions

Resistance TrainingImmobilization

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaInvestigative Techniques

Study Officials

  • Stuart M Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Investigators and participants will have knowledge or which leg will be undergoing resistance training and which will be immobilized.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The model will be a within-subject intervention. Each subject will have one leg randomized to unilateral resistance exercise (for 10 weeks) and the other to immobilization (for the last 2 weeks of the study).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 8, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

The individual participant data will not be available to other researchers.

Locations