A Study on the Clinical Efficacy and Safety Evaluation of Mindfulness Meditation During Dialysis Combined With Pre-Dialysis Progressive Resistance Training for Hemodialysis Patients With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in 30-second Chair Stand Test (CS30)
研究概览
简要总结
Objective: To investigate the clinical efficacy and safety of mindfulness meditation during dialysis combined with pre-dialysis progressive resistance training (PRT) for sarcopenia in patients undergoing maintenance hemodialysis (MHD).
Methods: In the randomized controlled trial, 76 MHD patients with sarcopenia were divided into three groups: control group (CG), sports group (SG), and intervention group (IG). All groups received standard dialysis, health education, and dietary guidance. The SG received pre-dialysis PRT, while the IG added mindfulness meditation during dialysis. Efficacy and safety were evaluated at baseline and after 12 weeks. Ultrasound assessments of muscle mass were conducted at baseline, week 4, week 8, and week 12.
详细描述
Control Group: Received routine hemodialysis treatment. Sports Group: Received pre-dialysis resistance training in addition to routine treatment.
Combined Intervention Group: Received mindfulness meditation training during dialysis in addition to exercise therapy.
The study was designed as a single-blind trial. The outcome assessors were blinded to group allocation to reduce assessment bias, particularly in the evaluation of subjective measures such as sleep quality, anxiety, and depression.
Interventions and Methods: Including 4 parts: Part 1 comprehensive assessment and preliminary education; Part 2 testing of one repetition maximum (1RM); Part 3 pre-dialysis resistance training; Part 4 mindfulness meditation training during dialysis.
Comprehensive Assessment and Preliminary Education: Collection of general information (including gender, age, dialysis age, primary disease, etc.). Health education, dietary guidance (calorie intake 30-35kj/kg/d; protein intake 1.0-1.2g/kg/d; maintain weight gain during dialysis within 3%-5% of dry weight). Establishment of a joint intervention team (including 2 meditation instructors, 1 rehabilitation therapist, 2 specialists, and 2 nurses). One week before the trial, patients were introduced to the theoretical knowledge, specific methods, and precautions of mindfulness meditation and PRT training. According to the "Expert Consensus on Exercise Rehabilitation for Chinese Adult Patients with Chronic Kidney Disease" , all participants had no serious complications or comorbidities and were all medium-low risk patients who could undergo incremental moderate-high intensity RT (1 RM 70-85% exercise load).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the updated Asian diagnostic criteria for sarcopenia
- •Stable vital signs and general physical condition
- •Willing and able to cooperate with supervised exercise training
- •Regular hemodialysis 3 times per week for at least 3 months
排除标准
- •Acute cardiovascular or cerebrovascular events within the previous 3 months
- •Cognitive dysfunction affecting study cooperation and exercise completion
- •Severe osteoarticular or limb movement disorders preventing standardized exercise training
- •Active systemic infection
结局指标
主要结局
Change in 30-second Chair Stand Test (CS30)
时间窗: 12 weeks
The range of the test result is 0-30 repetitions. Higher values indicate better lower limb muscle strength and physical function. The change value before and after 12-week intervention is the evaluation index
Change in Handgrip Strength
时间窗: 12 weeks
The unit of handgrip strength is kg. Higher values indicate improved upper limb muscle strength. The change value before and after 12-week intervention is the evaluation index
Change in 6-Minute Walking Test (6MWT)
时间窗: 12 weeks
The unit of walking distance is meters. Longer walking distance indicates better exercise tolerance and physical endurance. The change value before and after 12-week intervention is the evaluation index.
Change in Stair Climbing Test
时间窗: 12 weeks
The unit of test result is seconds. Shorter completion time indicates improved lower limb motor function. The change value before and after 12-week intervention is the evaluation index.
Change in 10-Time Sit-to-Stand Test (TT10SU)
时间窗: 12 weeks
The unit of test result is seconds. Shorter completion time indicates better lower limb muscle function. The change value before and after 12-week intervention is the evaluation index.
Change in Timed Up and Go Test (TUGT)
时间窗: 12 weeks
The unit of test result is seconds. Shorter completion time indicates better balance and mobility function. The change value before and after 12-week intervention is the evaluation index.
Change in skeletal muscle thickness measured by ultrasound
时间窗: 4 weeks
The unit of skeletal muscle thickness is cm. Greater muscle thickness indicates improved muscle mass. The change value before and after 12-week intervention is the evaluation index.
Change in quality of life assessed by standardized scale
时间窗: 12 weeks
Higher scores of the standardized quality of life scale represent improved quality of life and physical performance. The change value before and after 12-week intervention is the evaluation index.
次要结局
未报告次要终点