The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation - a Matched-Pair Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Upper body strength
研究概览
简要总结
The goal of this clinical trial is to assess the effects of eccentric arm-crank (KREHA) training compared to standard clinical routine strength (STAN) training in individuals undergoing primary spinal cord injury (SCI) rehabilitation.
The main questions this trail aims to answer are:
- what are the effects of the training on upper body strength, aerobic performance, muscle volume, functional independence, and health-related quality of life?
- is the KREHA training feasible to implement into the rehabilitation routine?
Participants will:
- perform either 20 KREHA sessions or 20 STAN sessions within 12 weeks
- perform a test battery to collect data on training effects before (pretest) and after (posttest) the study intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •informed consent as confirmed per signature.
- •traumatic or disease-related SCI.
- •participating in the routine strength training program during primary SCI rehabilitation at the study center (generally this is initiated around one month after SCI onset).
- •wheelchair dependency during activities of daily living, defined by a score of 0-2 in the SCIM subsection regarding "Mobility in the house".
- •passed sports medical assessment and having sufficient biceps/triceps function to perform arm-crank training, as determined by an experienced sports medicine physician
排除标准
- •inflammatory or neurodegenerative diseases (including multiple sclerosis or Guillain-Barré syndrome).
- •comorbidities or other health issues that may interfere with study participation, inability or contraindications to undergo the investigated intervention.
- •MRI contraindications (magnetic metal parts or electronic implants such as pacemakers in the body).
- •pregnancy (anamnestic).
研究组 & 干预措施
Eccentric arm-crank (KREHA) training
The eccentric training intervention consists of 20 training sessions performed on a symmetric arm-crank (Krafttraining mittels exzentrischer Handkurbel, KREHA) device. The training sessions have a duration of approximately 30 min and will be completed within twelve weeks, with a maximum of three sessions per week.
干预措施: Eccentric (KREHA) training (Procedure)
Standard clinical routine strength (STAN) training
The standard strength training intervention consists of a total of 20 training sessions at the gym of the study center, performed following clinical routine procedures. The training sessions have a duration of approximately 60 min and will be completed within twelve weeks, with around three sessions per week.
干预措施: Standard clinical routine strength (STAN) training (Procedure)
结局指标
主要结局
Upper body strength
时间窗: < 1 week pre and 12 weeks post intervention start.
Change in upper body strength will be measured by a one-repetition maximum (1RM) bench press (in kg). The maximum amount of weight that can be pushed upwards for one repetition, while lying in a supine position on a weight training bench.
次要结局
- Arm circumference(< 1 week pre and 12 weeks post intervention start.)
- Upper body strength(< 1 week pre and 12 weeks post intervention start.)
- Handgrip strength(< 1 week pre and 12 weeks post intervention start.)
- Aerobic performance(< 1 week pre and 12 weeks post intervention start.)
- Muscle volume(< 1 week pre and 12 weeks post intervention start.)
- Functioning during activities of daily living(< 1 week pre and 12 weeks post intervention start.)
- Health-related quality of life(< 1 week pre and 12 weeks post intervention start.)