Muscle WeaknessMiNDNCT07166198
Mitigating Neural Hypoexcitability and Weakness During Disuse in Women
A study testing Wrist immobilization, Resistance training and Resistance training rehabilitation in people with Muscle Weakness, run by Kansas State University at 1 site in United States.
Trial summary
Clinical trial The goal of this clinical trial is to learn how muscle weakness and atrophy develop during short periods of arm immobilization and whether a type of exercise called cross-education can help reduce these effects in women at midlife. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Wrist immobilization, Resistance training and Resistance training rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between 40-65 years of age
- Baseline handgrip strength >16Kg
Who cannot join
- Personal or family history of blood clots
- Current use of anticoagulant medications
- Neuromuscular or metabolic diseases (e.g., multiple sclerosis, diabetes)
- Arthritis
- Osteoporosis or osteopenia
- History of myocardial infarction within the past year
Show all 22Show fewer
- Chronic pain ≥3/10 for ≥3 months
- Uncontrolled hypertension (≥140/90 mmHg)
- Upper extremity surgery within the past year
- Use of assistive hand or arm device within the past year
- Fall involving the upper extremities within the past year
- Upper extremity injuries preventing safe participation
- Current use of muscle relaxants, benzodiazepines, or similar drugs
- Smoking within the past 6 months
- History of drug or alcohol abuse within the past year
- Severe anxiety or claustrophobia
- Pregnancy (current or planned)
- Allergies to medical adhesives
- High risk of sarcopenia (per SARC-F)
- Contraindications to TMS or MRI
- Upper-body resistance training within the past 6 months
- Inability/unwillingness to refrain from resistance training during study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julio Hernandez-Pavon, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Neuromuscular Physiology Laboratory
Manhattan, Kansas, 66506
Joshua Carr, PhD, 785-532-0700, joshuacarr@ksu.edu
About this study
Clinical trial The goal of this clinical trial is to learn how muscle weakness and atrophy develop during short periods of arm immobilization and whether a type of exercise called cross-education can help reduce these effects in women at midlife.
The main questions it aims to answer are:
Read more
What changes happen in the nervous system that lead to weakness when a wrist is immobilized?
Can training the opposite arm help maintain muscle strength, muscle size, and nervous system function in the immobilized arm?
Researchers will compare women who have their wrist immobilized with or without opposite-arm resistance training.
Participants will:
Wear a wrist cast on one arm for 7 days
Complete strength training with the opposite arm or no training, depending on their group
Attend study visits for strength and nervous system testing
Have non-invasive tests (like magnetic brain stimulation, muscle recordings, and muscle imaging) to measure how the nervous system and muscle responds
Read the detailed description
This clinical trial employs a two-phase, parallel-group randomized controlled design targeting midlife women (ages 40-65), stratified by menopausal status. Participants will be randomized to either a cross-education training group (TRAIN) or a standard care control group (CONTROL).
Phase 1 (Immobilization and Cross-Education Intervention):
To induce rapid declines in neuromuscular function, participants will undergo unilateral wrist immobilization of the non-dominant arm using a hard cast for 7 days. During this period, the TRAIN group will complete three resistance training sessions with the non-immobilized arm, while the CONTROL group will remain inactive. The intervention protocol emphasizes maximal effort contractions. The protocol was developed from prior laboratory work and proof-of-concept interventions, with the goal of maximizing the cross-education response.
Phase 2 (Rehabilitation and Recovery):
Following cast removal, both groups will complete a 2-week standardized rehabilitation program (3 sessions per week) designed to restore wrist strength and function in the previously immobilized arm. Rehabilitation training includes progressive resistance exercise to target recovery of neuromuscular performance.
- Conditions
- Muscle Weakness
- Being tested
- Wrist immobilization, Resistance training, Resistance training rehabilitation
- Keywords
- Resistance Training, Neuroplasticity, Muscle Disuse, Wrist immobilization, Women's Health
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist immobilizationDevice
The wrist immobilization will use a medical device (wrist cast) to immobilize the left, non-dominant wrist for 7 days.
Resistance trainingBehavioural
The cross-education intervention will consist of resistance training on the dominant hand.
Resistance training rehabilitationBehavioural
The resistance training rehabilitation will occur for the non-dominant hand following the immobilization phase for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (TRAIN) | Experimental | This group will receive the experimental intervention Receives: Device: Wrist immobilization; Behavioral: Resistance training; Behavioral: Resistance training rehabilitation |
| Control Group (CON) | Active comparator | This group will not receive the experimental intervention Receives: Device: Wrist immobilization; Behavioral: Resistance training rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
Maximal handgrip strength (Kg) using an isometric handgrip dynamometer.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Wrist Extension Strength
Peak torque (Nm) of the wrist extensor muscles measured using isokinetic dynamometry
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Wrist Flexion Strength
Peak torque (Nm) of the wrist flexor muscles measured using isokinetic dynamometry.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Secondary outcomes (6)
Wrist Muscle Cross-Sectional Area and Volume (CT Imaging)
Muscle cross-sectional area (cm²) and volume (cm³) of the wrist extensors and flexors, assessed using computed tomography (CT). Scans will be obtained at standardized anatomical landmarks of the forearm. Cross-sectional images will be segmented and analyzed with imaging software to quantify muscle size. The primary outcome is mean muscle cross-sectional area, with muscle volume derived from consecutive slices. These measures provide indices of muscle size and atrophy/hypertrophy over time.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Motor Evoked Potential (MEP) Amplitude
Amplitude (mV) of motor-evoked potentials elicited by single-pulse TMS applied over the primary motor cortex of the left wrist and recorded from the extensor carpi radialis muscle. Larger amplitudes reflect greater corticospinal excitability.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Short-Interval Intracortical Inhibition (SICI)
Short-interval intracortical inhibition assessed by paired-pulse TMS with a subthreshold conditioning stimulus followed by a suprathreshold test stimulus at an interstimulus interval of 2-5 ms. Outcome is the percent suppression of MEP amplitude relative to unconditioned trials.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Long-Interval Intracortical Inhibition (LICI)
Assessed using paired-pulse TMS with a suprathreshold conditioning stimulus followed by a suprathreshold test stimulus at an interstimulus interval of 50-200 ms. LICI is quantified as the percent suppression of conditioned motor-evoked potential (MEP) amplitude relative to unconditioned MEPs.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Intracortical Facilitation (ICF)
Assessed using paired-pulse TMS with a subthreshold conditioning stimulus followed by a suprathreshold test stimulus at an interstimulus interval of 8-20 ms. ICF is quantified as the percent increase of conditioned MEP amplitude relative to unconditioned MEPs.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Active Motor Threshold (AMT)
Defined as the lowest TMS stimulus intensity (expressed as a percentage of maximum stimulator output) required to evoke MEPs ≥200 μV in at least 5 out of 10 consecutive trials during voluntary contraction of the target muscle at 10% of maximal effort. AMT reflects corticospinal excitability during an active state.
Measured: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 May 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-phase, parallel-group randomized controlled design targeting midlife women aged 40-65 years, stratified by menopausal status.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Joshua Carr, Kansas State University
- Investigators
- Joshua Carr, Ph.D., Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166198
- Sponsor's protocol ID
- 12503
- Other IDs
- 5P20GM113109-09
- Acronym
- MiND
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results of publications (e.g., outcome measures, demographics, adverse events) will be deposited in a publicly accessible data repository (Open Science Framework). Data will be available following publication of primary results. Supporting materials, including the study protocol and statistical analysis plan, will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Neural Hypoexcitability and Weakness During Disuse in Women
- ClinicalTrials.gov ID
- NCT07166198
- Acronym / sponsor ID
- MiND / 12503
- Conditions
- Muscle Weakness
- Keywords
- Resistance Training, Neuroplasticity, Muscle Disuse, Wrist immobilization, Women's Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Sep 2025 (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.
Clinical trial The goal of this clinical trial is to learn how muscle weakness and atrophy develop during short periods of arm immobilization and whether a type of exercise called cross-education can help reduce these effects in women at midlife.
The main questions it aims to answer are:
What changes happen in the nervous system that lead to weakness when a wrist is immobilized?
Can training the opposite arm help maintain muscle strength, muscle size, and nervous system function in the immobilized arm?
Researchers will compare women who have their wrist immobilized with or without opposite-arm resistance training.
Participants will:
Wear a wrist cast on one arm for 7 days
Complete strength training with the opposite arm or no training, depending on their group
Attend study visits for strength and nervous system testing
Have non-invasive tests (like magnetic brain stimulation, muscle recordings, and muscle imaging) to measure how the nervous system and muscle responds
Detailed description
This clinical trial employs a two-phase, parallel-group randomized controlled design targeting midlife women (ages 40-65), stratified by menopausal status. Participants will be randomized to either a cross-education training group (TRAIN) or a standard care control group (CONTROL).
Phase 1 (Immobilization and Cross-Education Intervention):
To induce rapid declines in neuromuscular function, participants will undergo unilateral wrist immobilization of the non-dominant arm using a hard cast for 7 days. During this period, the TRAIN group will complete three resistance training sessions with the non-immobilized arm, while the CONTROL group will remain inactive. The intervention protocol emphasizes maximal effort contractions. The protocol was developed from prior laboratory work and proof-of-concept interventions, with the goal of maximizing the cross-education response.
Phase 2 (Rehabilitation and Recovery):
Following cast removal, both groups will complete a 2-week standardized rehabilitation program (3 sessions per week) designed to restore wrist strength and function in the previously immobilized arm. Rehabilitation training includes progressive resistance exercise to target recovery of neuromuscular performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-phase, parallel-group randomized controlled design targeting midlife women aged 40-65 years, stratified by menopausal status.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (TRAIN) | Experimental | Device: Wrist immobilization, Behavioral: Resistance training, Behavioral: Resistance training rehabilitationThis group will receive the experimental intervention |
| Control Group (CON) | Active comparator | Device: Wrist immobilization, Behavioral: Resistance training rehabilitationThis group will not receive the experimental intervention |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women between 40-65 years of age
- Baseline handgrip strength >16Kg
Key exclusion criteria (22 listed)
- Personal or family history of blood clots
- Current use of anticoagulant medications
- Neuromuscular or metabolic diseases (e.g., multiple sclerosis, diabetes)
- Arthritis
- Osteoporosis or osteopenia
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 |
|---|---|---|
| Wrist immobilizationThe wrist immobilization will use a medical device (wrist cast) to immobilize the left, non-dominant wrist for 7 days. | Device | Control Group (CON), Intervention Group (TRAIN) |
| Resistance trainingThe cross-education intervention will consist of resistance training on the dominant hand. | Behavioural | Intervention Group (TRAIN) |
| Resistance training rehabilitationThe resistance training rehabilitation will occur for the non-dominant hand following the immobilization phase for all participants. | Behavioural | Control Group (CON), Intervention Group (TRAIN) |
Primary outcome
Handgrip Strength
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Maximal handgrip strength (Kg) using an isometric handgrip dynamometer.
Wrist Extension Strength
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Peak torque (Nm) of the wrist extensor muscles measured using isokinetic dynamometry
Wrist Flexion Strength
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Peak torque (Nm) of the wrist flexor muscles measured using isokinetic dynamometry.
6 secondary outcomes
Wrist Muscle Cross-Sectional Area and Volume (CT Imaging)
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Motor Evoked Potential (MEP) Amplitude
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Short-Interval Intracortical Inhibition (SICI)
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Long-Interval Intracortical Inhibition (LICI)
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Intracortical Facilitation (ICF)
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Active Motor Threshold (AMT)
Time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results of publications (e.g., outcome measures, demographics, adverse events) will be deposited in a publicly accessible data repository (Open Science Framework). Data will be available following publication of primary results. Supporting materials, including the study protocol and statistical analysis plan, will also be shared.
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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.
Julio Hernandez-Pavon, Ph.D. contact
Joshua Carr, Ph.D. principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist immobilization, Resistance training and Resistance training rehabilitation in people with Muscle Weakness, run by Kansas State University at 1 site in United States.
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 2 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Carr, Ph.D. (785-532-0700, joshuacarr@ksu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip Strength (time frame: Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.). The study lists 3 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 10 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.