NCT05115643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

October 10, 2021

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in right and left primary motor cortex thickness

    Comparison between before and after 2 weeks of left arm immobilization

  • Change in whole brain resting state functional connectivity

    Comparison between before and after 2 weeks of left arm immobilization

Other Outcomes (4)

  • 2-day caloric and macronutrient intake, before immobilization

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

  • 2-day caloric and macronutrient intake, during immobilization

    Measured during the last 2 days of left arm immobilization

  • Ovarian hormone concentrations (estradiol, progesterone)

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

  • +1 more other outcomes

Study Arms (2)

Immobilized arm

EXPERIMENTAL

Left arm of participant

Behavioral: Immobilization

Non-immobilized arm

NO INTERVENTION

Right arm of participant

Interventions

ImmobilizationBEHAVIORAL

Immobilization of left arm using a brace and sling.

Immobilized arm

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism and Nutrition Research Laboratory

Montreal, Quebec, H2W 1S4, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 10, 2021

First Posted

November 10, 2021

Study Start

October 8, 2021

Primary Completion

April 21, 2022

Study Completion

April 21, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations