The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients

Baduanjin Exercise on Maintenance Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Shoulder Joint Disorder; CKD-MBD
• Intervention / Treatment: Other: Baduanjin exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baduanjin exercise group; 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.	Other: Baduanjin exercise; 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.
No Intervention: Control group; Patients in this group maintain their conventional therapy and daily life activities, and there is no intervention given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Chair: Li Yuan, MD, Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2021-K151-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared after request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No