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The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation (HYPAT)

Primary Purpose

Muscle Atrophy, Disuse Atrophy (Muscle) of Lower Leg

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Unilateral Resistance Exercise
Immobilization
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Atrophy focused on measuring Muscle Hypertrophy, Muscle Atrophy, Resistance Training, Immobilization

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Exercise Metabolism Research Laboratory, McMaster Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unilateral Resistance Exercise

Immobilization

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Skeletal Muscle Gene Expression
Gene expression will be quantified pre-training (week 0) and post-training/immobilization from muscle tissue samples obtained via muscle biopsies in both legs. Gene expression assessment will take place over a continuous period of 7 months.

Full Information

First Posted
February 2, 2017
Last Updated
June 17, 2019
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03046095
Brief Title
The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation
Acronym
HYPAT
Official Title
The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Resistance exercise, paired with protein ingestion, leads to the accretion of muscle proteins that over time results in the augmentation of muscle size and muscle strength. By virtue of its ability to stimulate increases in muscle size and strength, resistance exercise is an effective method that can be used by healthcare practitioners to promote the recovery of lost muscle mass resulting from a period of immobilization (resulting from broken bones, elective surgery, etc.). However, while exercise in general is an effective therapeutic strategy to combat muscle loss and frailty, the extent to which individuals respond to resistance exercise is highly variable. Some individuals exhibit large changes in muscle size (high responders) whereas other exhibit little to no change (low responders). Thus, where as one resistance exercise program might be an appropriate treatment for one individual following disuse, another individual might require a greater stimulus and/or pharmaceutical assistance in order to fully recover. What is currently unknown is whether individuals who experience the most profound increases in skeletal muscle mass following resistance exercise also lose the most muscle upon limb immobilization. Answering this gap in our knowledge will be the primary goal of this study. The procurement of this knowledge will hopefully permit the development of individualized exercise programs that can be used to influence the recovery of skeletal muscle that is lost with inactivity and immobilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy, Disuse Atrophy (Muscle) of Lower Leg
Keywords
Muscle Hypertrophy, Muscle Atrophy, Resistance Training, Immobilization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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).
Masking
None (Open Label)
Masking Description
Investigators and participants will have knowledge or which leg will be undergoing resistance training and which will be immobilized.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral Resistance Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Immobilization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Unilateral Resistance Exercise
Other Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Immobilization
Other Intervention Name(s)
Knee Bracing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Cross Sectional Area
Description
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.
Time Frame
May 2017 - Dec 2017
Title
Leg Lean Mass
Description
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.
Time Frame
May 2017 - Dec 2017
Secondary Outcome Measure Information:
Title
Skeletal Muscle Gene Expression
Description
Gene expression will be quantified pre-training (week 0) and post-training/immobilization from muscle tissue samples obtained via muscle biopsies in both legs. Gene expression assessment will take place over a continuous period of 7 months.
Time Frame
May 2017 - Dec 2017

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Non-Smoker Do not heavily consume alcohol Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart M Phillips, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Metabolism Research Laboratory, McMaster Univeristy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data will not be available to other researchers.

Learn more about this trial

The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation

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