The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation (HYPAT)
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|ClinicalTrials.gov Identifier: NCT03046095|
Recruitment Status : Not yet recruiting
First Posted : February 8, 2017
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Muscle Atrophy Disuse Atrophy (Muscle) of Lower Leg||Other: Unilateral Resistance Exercise Procedure: Immobilization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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.|
|Primary Purpose:||Basic Science|
|Official Title:||The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||January 1, 2018|
|Estimated Study Completion Date :||January 1, 2018|
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.
Other: Unilateral Resistance Exercise
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 Name: Resistance training
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.
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 Name: Knee Bracing
- 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.
- Leg Lean Mass [ Time Frame: May 2017 - Dec 2017 ]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.
- Skeletal Muscle Gene Expression [ Time Frame: May 2017 - Dec 2017 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046095
|Contact: Stuart M Phillips, PhD||905-525-9140 ext firstname.lastname@example.org|
|Exercise Metabolism Research Laboratory, McMaster Univeristy|
|Hamilton, Ontario, Canada, L8S 4K1|
|Principal Investigator:||Stuart M Phillips, PhD||McMaster University|