- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115643
Brain and Muscle Plasticity During Immobilization
Examining Changes in Muscle Size and Strength, Neuromuscular Function, and Brain Plasticity During Limb Immobilization in Women
Patients in rehabilitation may undergo periods of prolonged limb immobilization in response to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling the affected limb can decrease significantly, possibly resulting in physical impairment or lower quality of life during the recovery phase. Prior immobilization studies have shown that the rate and degree of decline in muscle strength exceeds that of muscle size, indicating that determinants of muscle strength unrelated to muscle size may further contribute to functional changes during immobilization.
The purpose of this study is to describe the changes in muscle strength, muscle size, corticospinal excitability, voluntary activation, M1 cortical thickness, and resting state functional connectivity following a 2-week limb immobilization period in young women.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2W 1S4
- Exercise Metabolism and Nutrition Research Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biologically female
- Right-hand dominant
- Body mass index between 18.5-30 kg/m^2 (inclusive)
- Regular menstrual cycle
- Be able to maintain a habitual diet throughout the duration of the study
Exclusion Criteria:
- Use of tobacco
- Pregnancy
- A history of brain trauma
- Suffers from a neurological disease or movement disorder
- Peripheral nerve damage
- Use of medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatory drugs, or prescription strength acne medications)
- Diagnosed with or suspects having a psychiatric illness
- Use of dietary supplements known to affect muscle size (i.e., creatine, fish oil)
- Past or present diagnosis of an eating disorder by a physician or registered dietician
- Possesses any metal implants (e.g. artificial joints, pacemakers, stents) or non-removeable medical devices that are contraindicative for magnetic resonance imaging (e.g. insulin pumps)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Immobilized arm
Left arm of participant
|
Immobilization of left arm using a brace and sling.
|
|
NO_INTERVENTION: Non-immobilized arm
Right arm of participant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in isometric elbow flexion and extension peak torque, both arms
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Measured using an isokinetic dynamometer; peak torque during static contraction of the elbow flexors and extensors
|
Comparison between before and after 2 weeks of left arm immobilization
|
|
Change in isokinetic elbow flexion and extension peak torque, both arms
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Measured using an isokinetic dynamometer; peak torque during dynamic contraction of the elbow flexors and extensors
|
Comparison between before and after 2 weeks of left arm immobilization
|
|
Change in cross-sectional area of the elbow flexor and extensor muscles, both arms
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Obtained from magnetic resonance images of each arm
|
Comparison between before and after 2 weeks of left arm immobilization
|
|
Change in volume of the elbow flexor and extensor muscles, both arms
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Obtained from magnetic resonance images of each arm
|
Comparison between before and after 2 weeks of left arm immobilization
|
|
Voluntary activation of biceps brachii, both arms
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Measured using peripheral nerve stimulation and an isokinetic dynamometer; estimation of the capacity to voluntarily activate the force-generating elements of the biceps brachii during maximal effort elbow flexion
|
Comparison between before and after 2 weeks of left arm immobilization
|
|
Change in corticospinal excitability of biceps brachii, both arms
Time Frame: Comparison between before immobilization and 24 hours of left arm immobilization, and before and after 2 weeks of left arm immobilization
|
Measured using transcranial magnetic stimulation; estimation of the efficacy of the corticospinal tract to relay electrical signals to the biceps brachii muscle
|
Comparison between before immobilization and 24 hours of left arm immobilization, and before and after 2 weeks of left arm immobilization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in right and left primary motor cortex thickness
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Obtained from magnetic resonance image of the brain
|
Comparison between before and after 2 weeks of left arm immobilization
|
|
Change in whole brain resting state functional connectivity
Time Frame: Comparison between before and after 2 weeks of left arm immobilization
|
Obtained from magnetic resonance image of the brain
|
Comparison between before and after 2 weeks of left arm immobilization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-day caloric and macronutrient intake, before immobilization
Time Frame: Measured during the 2-day period right before left arm immobilization
|
Obtained using self-reported dietary intake records
|
Measured during the 2-day period right before left arm immobilization
|
|
2-day caloric and macronutrient intake, during immobilization
Time Frame: Measured during the last 2 days of left arm immobilization
|
Obtained using self-reported dietary intake records
|
Measured during the last 2 days of left arm immobilization
|
|
Ovarian hormone concentrations (estradiol, progesterone)
Time Frame: Measured on day of left arm immobilization, before putting on the arm brace
|
Obtained using blood samples
|
Measured on day of left arm immobilization, before putting on the arm brace
|
|
Ovarian hormone concentrations (estradiol, progesterone)
Time Frame: Measured after 2 weeks of left arm immobilization
|
Obtained using blood samples
|
Measured after 2 weeks of left arm immobilization
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A00-M01-21A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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