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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05115643
Other study ID # A00-M01-21A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2021
Est. completion date April 21, 2022

Study information

Verified date May 2022
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 21, 2022
Est. primary completion date April 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Immobilization
Immobilization of left arm using a brace and sling.

Locations

Country Name City State
Canada Exercise Metabolism and Nutrition Research Laboratory Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 2-day caloric and macronutrient intake, before immobilization Obtained using self-reported dietary intake records Measured during the 2-day period right before left arm immobilization
Other 2-day caloric and macronutrient intake, during immobilization Obtained using self-reported dietary intake records Measured during the last 2 days of left arm immobilization
Other Ovarian hormone concentrations (estradiol, progesterone) Obtained using blood samples Measured on day of left arm immobilization, before putting on the arm brace
Other Ovarian hormone concentrations (estradiol, progesterone) Obtained using blood samples Measured after 2 weeks of left arm immobilization
Primary Change in isometric elbow flexion and extension peak torque, both arms 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
Primary Change in isokinetic elbow flexion and extension peak torque, both arms 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
Primary Change in cross-sectional area of the elbow flexor and extensor muscles, both arms Obtained from magnetic resonance images of each arm Comparison between before and after 2 weeks of left arm immobilization
Primary Change in volume of the elbow flexor and extensor muscles, both arms Obtained from magnetic resonance images of each arm Comparison between before and after 2 weeks of left arm immobilization
Primary Voluntary activation of biceps brachii, both arms 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
Primary Change in corticospinal excitability of biceps brachii, both arms 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 Change in right and left primary motor cortex thickness Obtained from magnetic resonance image of the brain Comparison between before and after 2 weeks of left arm immobilization
Secondary Change in whole brain resting state functional connectivity Obtained from magnetic resonance image of the brain Comparison between before and after 2 weeks of left arm immobilization
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