Mitigating Neural Hypoexcitability and Weakness During Disuse in Women

NCT07166198 | Not Yet Recruiting FDA Device

• 2 other identifiers: 125035P20GM113109-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Muscle Weakness

Keywords

Resistance Training; Neuroplasticity; Muscle Disuse; Wrist immobilization; Women's Health

Outcome Measures

Primary Outcomes (3)

• Handgrip Strength

  Maximal handgrip strength (Kg) using an isometric handgrip dynamometer.

  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

  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.

  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)

  Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.

• Motor Evoked Potential (MEP) Amplitude

  Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.

• Short-Interval Intracortical Inhibition (SICI)

  Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.

• Long-Interval Intracortical Inhibition (LICI)

  Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.

• Intracortical Facilitation (ICF)

  Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.

Other Outcomes (2)

• Menopausal Hormone Profile

  Baseline

• Physical Activity Levels

  Phase 1 (1 week immobilization) and Phase 2 (2-3 weeks rehabilitation)

Study Arms (2)

Intervention Group (TRAIN)

EXPERIMENTAL

This group will receive the experimental intervention

Device: Wrist immobilization; Behavioral: Resistance training; Behavioral: Resistance training rehabilitation

Control Group (CON)

ACTIVE COMPARATOR

This group will not receive the experimental intervention

Device: Wrist immobilization; Behavioral: Resistance training rehabilitation

Interventions

Resistance training BEHAVIORAL

The cross-education intervention will consist of resistance training on the dominant hand.

Intervention Group (TRAIN)

Wrist immobilization DEVICE

The wrist immobilization will use a medical device (wrist cast) to immobilize the left, non-dominant wrist for 7 days.

Control Group (CON); Intervention Group (TRAIN)

Resistance training rehabilitation BEHAVIORAL

The resistance training rehabilitation will occur for the non-dominant hand following the immobilization phase for all participants.

Control Group (CON); Intervention Group (TRAIN)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 40-65 years of age
• Baseline handgrip strength \>16Kg

You may not qualify if:

• 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
• 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
• Use of body composition-altering medications (e.g., testosterone, GLP-1 agonists) in past 6 months
• Current use of muscle relaxants, benzodiazepines, or similar drugs
• Smoking within the past 6 months

Sponsors & Collaborators

• Kansas State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Neuromuscular Physiology Laboratory

Manhattan, Kansas, 66506, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joshua Carr, Ph.D.

  Kansas State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Carr, Ph.D.

CONTACT

785-532-0700; joshuacarr@ksu.edu

Julio Hernandez-Pavon, Ph.D.

CONTACT

juliohpavon@ksu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-phase, parallel-group randomized controlled design targeting midlife women aged 40-65 years, stratified by menopausal status.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available following publication of primary results.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan) will be available on the Open Science Framework (OSF) repository following publication of primary results. Data will be accessible to all registered OSF users without restriction. Users will be able to download the datasets and associated documentation directly from the project repository page.

Locations

US (1)