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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baduanjin exercise group | Experimental | Before starting dialysis,Patients perform Baduanjin exercises. All Baduanjin training is provided by a professional doctor who has received training on BaduanJin and obtained certificate. Each session is approximately 30 minutes in duration, consisting of 5 minutes of warm-up exercises, 20 minutes of Baduanjinpractice, and 5 minutes of cool-down exercises. |
|
| Control group | No Intervention | Patients in this group maintain their conventional therapy and daily life activities, and there is no intervention given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baduanjin exercise | Other | Baduanjin has 8 movement forms, which are relatively less demanding. Assistive equipment is also not necessary during Baduanjin. These advantages make Baduanjin a suitable form of exercise training for dialysis patients.The movements involved in Baduanjin require the individual to reach beyond the base of support, change the base of support between bilateral and unilateral stance, and perform movements in a sustained squatting posture. These maneuvers challenge balance and require muscle strength to be executed successfully. In 8 movement forms of Baduanjin all include shoulder joint function exercises, thus making Baduanjin a potentially useful method for improving activity level and arm strength. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Yuan, MD | Affiliated Hospital of Nantong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226000 | China |
Data can be shared after request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2021 | Mar 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2021 | Mar 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| 0 month,6 month,12 month,18 month |
| 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 |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |