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Trial record 50 of 614 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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
Sponsor:
Information provided by (Responsible Party):
Stuart Phillips, McMaster University

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.

Condition or disease Intervention/treatment Phase
Muscle Atrophy Disuse Atrophy (Muscle) of Lower Leg Other: Unilateral Resistance Exercise Procedure: Immobilization Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
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
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.
Procedure: Immobilization
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Contact: Stuart M Phillips, PhD 905-525-9140 ext 24465 phillis@mcmaster.ca

Locations
Canada, Ontario
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Stuart M Phillips, PhD McMaster University

Responsible Party: Stuart Phillips, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT03046095     History of Changes
Other Study ID Numbers: 02051986
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data will not be available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stuart Phillips, McMaster University:
Muscle Hypertrophy
Muscle Atrophy
Resistance Training
Immobilization

Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Muscular Diseases
Atrophy
Muscular Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases
Neuromuscular Diseases