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Brain and Muscle Plasticity During Immobilization

Primary Purpose

Muscle Atrophy

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Immobilization

About this trial

This is an interventional basic science trial for Muscle Atrophy

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Exercise Metabolism and Nutrition Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immobilized arm

Non-immobilized arm

Arm Description

Left arm of participant

Right arm of participant

Outcomes

Primary Outcome Measures

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

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

Change in cross-sectional area of the elbow flexor and extensor muscles, both arms

Obtained from magnetic resonance images of each arm

Change in volume of the elbow flexor and extensor muscles, both arms

Obtained from magnetic resonance images of each arm

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

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

Secondary Outcome Measures

Change in right and left primary motor cortex thickness

Obtained from magnetic resonance image of the brain

Change in whole brain resting state functional connectivity

Obtained from magnetic resonance image of the brain

Full Information

NCT ID

NCT05115643

First Posted

October 10, 2021

Last Updated

May 17, 2022

Sponsor

McGill University

1. Study Identification

Unique Protocol Identification Number

NCT05115643

Brief Title

Brain and Muscle Plasticity During Immobilization

Official Title

Examining Changes in Muscle Size and Strength, Neuromuscular Function, and Brain Plasticity During Limb Immobilization in Women

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

October 8, 2021 (Actual)

Primary Completion Date

April 21, 2022 (Actual)

Study Completion Date

April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Atrophy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immobilized arm

Arm Type

Experimental

Arm Description

Left arm of participant

Arm Title

Non-immobilized arm

Arm Type

No Intervention

Arm Description

Right arm of participant

Intervention Type

Behavioral

Intervention Name(s)

Immobilization

Intervention Description

Immobilization of left arm using a brace and sling.

Primary Outcome Measure Information:

Title

Change in isometric elbow flexion and extension peak torque, both arms

Description

Measured using an isokinetic dynamometer; peak torque during static contraction of the elbow flexors and extensors

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Title

Change in isokinetic elbow flexion and extension peak torque, both arms

Description

Measured using an isokinetic dynamometer; peak torque during dynamic contraction of the elbow flexors and extensors

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Title

Change in cross-sectional area of the elbow flexor and extensor muscles, both arms

Description

Obtained from magnetic resonance images of each arm

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Title

Change in volume of the elbow flexor and extensor muscles, both arms

Description

Obtained from magnetic resonance images of each arm

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Title

Voluntary activation of biceps brachii, both arms

Description

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Title

Change in corticospinal excitability of biceps brachii, both arms

Description

Measured using transcranial magnetic stimulation; estimation of the efficacy of the corticospinal tract to relay electrical signals to the biceps brachii muscle

Time Frame

Comparison between before immobilization and 24 hours of left arm immobilization, and before and after 2 weeks of left arm immobilization

Secondary Outcome Measure Information:

Title

Change in right and left primary motor cortex thickness

Description

Obtained from magnetic resonance image of the brain

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Title

Change in whole brain resting state functional connectivity

Description

Obtained from magnetic resonance image of the brain

Time Frame

Comparison between before and after 2 weeks of left arm immobilization

Other Pre-specified Outcome Measures:

Title

2-day caloric and macronutrient intake, before immobilization

Description

Obtained using self-reported dietary intake records

Time Frame

Measured during the 2-day period right before left arm immobilization

Title

2-day caloric and macronutrient intake, during immobilization

Description

Obtained using self-reported dietary intake records

Time Frame

Measured during the last 2 days of left arm immobilization

Title

Ovarian hormone concentrations (estradiol, progesterone)

Description

Obtained using blood samples

Time Frame

Measured on day of left arm immobilization, before putting on the arm brace

Title

Ovarian hormone concentrations (estradiol, progesterone)

Description

Obtained using blood samples

Time Frame

Measured after 2 weeks of left arm immobilization

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Exercise Metabolism and Nutrition Research Laboratory

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S4

Country

Canada

12. IPD Sharing Statement

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Brain and Muscle Plasticity During Immobilization

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