Muscle AtrophyNCT05115643
Brain and Muscle Plasticity During Immobilization
A study testing Immobilization in people with Muscle Atrophy, run by McGill University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- Immobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 8 Oct 2021to 21 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism and Nutrition Research Laboratory
Montreal, Quebec, H2W 1S4
About this study
Official title: 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.
- Conditions
- Muscle Atrophy
- Being tested
- Immobilization
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmobilizationBehavioural
Immobilization of left arm using a brace and sling.
| Study group | Role | What they receive |
|---|---|---|
| Immobilized arm | Experimental | Left arm of participant Receives: Behavioral: Immobilization |
| Non-immobilized arm | No intervention | Right arm of participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Comparison between before and after 2 weeks of left arm immobilization
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
Measured: 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
Obtained from magnetic resonance images of each arm
Measured: Comparison between before and after 2 weeks of left arm immobilization
Change in volume of the elbow flexor and extensor muscles, both arms
Obtained from magnetic resonance images of each arm
Measured: Comparison between before and after 2 weeks of left arm immobilization
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
Measured: Comparison between before and after 2 weeks of left arm immobilization
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
Measured: Comparison between before immobilization and 24 hours of left arm immobilization, and before and after 2 weeks of left arm immobilization
Secondary outcomes (2)
Change in right and left primary motor cortex thickness
Obtained from magnetic resonance image of the brain
Measured: Comparison between before and after 2 weeks of left arm immobilization
Change in whole brain resting state functional connectivity
Obtained from magnetic resonance image of the brain
Measured: Comparison between before and after 2 weeks of left arm immobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start8 Oct 2021
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Churchward-Venne, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115643
- Sponsor's protocol ID
- A00-M01-21A
- Status last verified
- May 2022
- First submitted
- 10 Oct 2021
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Changes in Muscle Size and Strength, Neuromuscular Function, and Brain Plasticity During Limb Immobilization in Women
- ClinicalTrials.gov ID
- NCT05115643
- Acronym / sponsor ID
- A00-M01-21A
- Conditions
- Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilized arm | Experimental | Behavioral: ImmobilizationLeft arm of participant |
| Non-immobilized arm | No intervention | –Right arm of participant |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Use of tobacco
- Pregnancy
- A history of brain trauma
- Suffers from a neurological disease or movement disorder
- Peripheral nerve damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmobilizationImmobilization of left arm using a brace and sling. | Behavioural | Immobilized arm |
Primary outcome
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
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
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
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
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
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
2 secondary outcomes
Change in right and left primary motor cortex thickness
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immobilization in people with Muscle Atrophy, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in isometric elbow flexion and extension peak torque, both arms (time frame: Comparison between before and after 2 weeks of left arm immobilization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.