Clinical trial NCT06314321: The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients
Official title: Baduanjin Exercise on Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Shoulder Joint Disorder
CKD-MBD
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder joint function score
timeFrame: 0 month，6 month，12 month，18 month
measure: Shoulder joint internal rotation function
timeFrame: 0 month，6 month，12 month，18 month
measure: Muscle strength measurement
timeFrame: 0 month，6 month，12 month，18 month
measure: Area of biceps brachii muscle
timeFrame: 0 month，6 month，12 month，18 month
Secondary outcomes:
measure: Changes in the Short Form-36 (SF-36) and European Quality of Life Five Dimension（EQ-5D-5L）
timeFrame: 0 month，6 month，12 month，18 month
measure: Changes in the Hospital Anxiety and Depression Scale （HADS）
timeFrame: 0 month，6 month，12 month，18 month
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Li Yuan, MD
role: STUDY_CHAIR
References: