Hemodialysis Complication Clinical Trial
Official title:
Baduanjin Exercise on Maintenance Hemodialysis Patients
Verified date | March 2024 |
Source | Affiliated Hospital of Nantong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 20, 2024 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Nantong University | Nantong | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital of Nantong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shoulder joint function score | 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). | 0 month,6 month,12 month,18 month | |
Primary | Shoulder joint internal rotation function | 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. | 0 month,6 month,12 month,18 month | |
Primary | Muscle strength measurement | 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. | 0 month,6 month,12 month,18 month | |
Primary | Area of biceps brachii muscle | Measure the thickness of the biceps brachii muscle in two groups of patients through skeletal muscle ultrasound examination. | 0 month,6 month,12 month,18 month | |
Secondary | Changes in the Short Form-36 (SF-36) and European Quality of Life Five Dimension(EQ-5D-5L) | Changes from the Short Form-36 (SF-36) and European Quality of Life Five Dimension(EQ-5D-5L)scale at 0 months, 8 months, 12 months. The SF-12 score is used to evaluate an individual's health status and quality of life. The SF-12 score expressed as a number between 0 and 100, with higher numbers indicating better health. EQ-5D-5L evaluate quality of life from five aspects: action ability, self-care, daily activities, pain or discomfort, anxiety or depression. The score range generally ranges from less than 0 to 1, and the higher the score, the better the state; The VAS score range is 0-100, with higher scores indicating better health status. | 0 month,6 month,12 month,18 month | |
Secondary | Changes in the Hospital Anxiety and Depression Scale (HADS) | Changes from HADS Index at at 0 months, 8 months, 12 months. HADS consists of 14 items, of which 7 items assess depression and 7 items assess anxiety. The scores for anxiety and depression range from 0 to 21, with higher scores indicating more severe symptoms. | 0 month,6 month,12 month,18 month |
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