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临床试验/NCT06314321
NCT06314321已完成不适用

Baduanjin Exercise on Maintenance Hemodialysis Patients

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Shoulder joint internal rotation function

研究概览

简要总结

The aim of this study is to examine the effect of 18-month Baduanjin exercise on shoulder joint function in maintenance hemodialysis (MHD) patients. 60 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities.

详细描述

The aim of this study is to observe the therapeutic effect of Baduanjin on improving shoulder joints in MHD patients. A total of 60 maintenance hemodialysis patients will be included and randomized into an intervention group of 30 cases and a control group of 30 cases. The intervention group underwent a 30 minute Baduanjin exercise under the guidance of a professional doctor before the dialysis day, including a 5-minute warm-up exercise, a 20 minute Baduanjin exercise, and a 5-minute relaxation exercise. The intervention group practice Baduanjin three days a week, while the control group maintain routine treatment and daily activities. Measure the indicators of each group at baseline, months 6, 12, and 18. The evaluation of shoulder joint function is based on the shoulder Constant score (which includes three dimensions: pain, daily living activities, and active range of motion); The quality of life score is based on the SF-12 score, and the emotional score is based on the Anxiety and Depression Scale.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18 years old, ≤ 75 years old
  • Maintenance dialysis treatment for ≥ 3 months, three times a week
  • The six minute walking experiment were used to screen patients for suitability for Baduanjin
  • Right handedness, fistula in left hand

排除标准

  • The vascular pathway is a tunnel catheter with a polyester sheath
  • The vascular pathway is a right arteriovenous fistula
  • Known infectious diseases
  • Individuals with primary or secondary muscle diseases, mental abnormalities, lack of autonomous behavior ability, and lack of cooperation with clinical observation and treatment.

结局指标

主要结局

Shoulder joint internal rotation function

时间窗: 0 month,6 month,12 month,18 month

The patient takes a standing position and measures the distance between the fingers and vertebrae of the hemodialysis patient's fistulae and non fistulae hands, that is, the patient moves their thumb with the backhand as much as possible along the midline of the back, and uses a tape measure to measure the closest distance from the tip of their thumb to the spinous process of the 7th cervical vertebra. Relevant data is organized and recorded.

Muscle strength measurement

时间窗: 0 month,6 month,12 month,18 month

Grip strength can reflect the strength of the hand muscles, and a grip strength meter is used to measure the grip strength of the patient's hands separately. The patient takes a standing position, holds the handle with maximum force, and records the value when the number on the machine display screen no longer changes. Test three times, take the maximum value, and record the relevant results.

Area of biceps brachii muscle

时间窗: 0 month,6 month,12 month,18 month

Measure the thickness of the biceps brachii muscle in two groups of patients through skeletal muscle ultrasound examination.

Shoulder joint function score

时间窗: 0 month,6 month,12 month,18 month

Using the adjusted version of the CMS scoring scale, the total score is 75 points, including pain (15 points), daily living ability (ADL, 20 points), and joint range of motion (ROM, 40 points).

次要结局

  • Changes in the Short Form-36 (SF-36) and European Quality of Life Five Dimension(EQ-5D-5L)(0 month,6 month,12 month,18 month)
  • Changes in the Hospital Anxiety and Depression Scale (HADS)(0 month,6 month,12 month,18 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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