Health TrialsbyHealthPanel

Mitigating Neural Hypoexcitability and Weakness During Disuse in Women

ConditionMuscle Weakness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorKansas State University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women between 40-65 years of age

Baseline handgrip strength >16Kg

Disqualifiers

Personal or family history of blood clots

Current use of anticoagulant medications

Neuromuscular or metabolic diseases (e.g., multiple sclerosis, diabetes)

Arthritis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wrist immobilization

    Device

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

  • Resistance training

    Behavioral

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

  • Resistance training rehabilitation

    Behavioral

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Intervention Group (TRAIN)Experimental treatment 3 interventions
Group B: Control Group (CON)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Handgrip Strength

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

Time frame
Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
2

Wrist Extension Strength

Peak torque (Nm) of the wrist extensor muscles measured using isokinetic dynamometry

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

Wrist Flexion Strength

Peak torque (Nm) of the wrist flexor muscles measured using isokinetic dynamometry.

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

Secondary outcomes

1

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.

Time frame
Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
2

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.

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

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.

Time frame
Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.
4

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.

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

Other outcomes

1

Menopausal Hormone Profile

Serum concentrations of estradiol, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) will be assessed from venous blood draws.

Time frame
Baseline
2

Physical Activity Levels

Physical activity levels, including daily step count and energy expenditure will be assessed using triaxial accelerometers (ActiGraph wGT3X-BT) worn on the dominant wrist.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kansas State University

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov
Apply now