Mitigating Neural Hypoexcitability and Weakness During Disuse in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Handgrip Strength
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 40-65 years of age
- •Baseline handgrip strength >16Kg
排除标准
- •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
- •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
研究组 & 干预措施
Intervention Group (TRAIN)
This group will receive the experimental intervention
干预措施: Wrist immobilization (Device)
Intervention Group (TRAIN)
This group will receive the experimental intervention
干预措施: Resistance training (Behavioral)
Intervention Group (TRAIN)
This group will receive the experimental intervention
干预措施: Resistance training rehabilitation (Behavioral)
Control Group (CON)
This group will not receive the experimental intervention
干预措施: Resistance training rehabilitation (Behavioral)
Control Group (CON)
This group will not receive the experimental intervention
干预措施: Wrist immobilization (Device)
结局指标
主要结局
Handgrip Strength
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Active Motor Threshold (AMT)(Baseline, immediately post-immobilization at 1 week, and post-rehabilitation at 3 weeks.)
研究者
Joshua Carr
Assistant Professor
Kansas State University