- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046095
The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation (HYPAT)
June 17, 2019 updated by: Stuart Phillips, McMaster University
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Unilateral Resistance Exercise
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.
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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.
Other Names:
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Experimental: Immobilization
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Cross Sectional Area
Time Frame: May 2017 - Dec 2017
|
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.
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May 2017 - Dec 2017
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Leg Lean Mass
Time Frame: May 2017 - Dec 2017
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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.
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May 2017 - Dec 2017
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal Muscle Gene Expression
Time Frame: May 2017 - Dec 2017
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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.
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May 2017 - Dec 2017
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
February 2, 2017
First Submitted That Met QC Criteria
February 4, 2017
First Posted (Estimate)
February 8, 2017
Study Record Updates
Last Update Posted (Actual)
June 18, 2019
Last Update Submitted That Met QC Criteria
June 17, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02051986
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The individual participant data will not be available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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