The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients

NCT06314321 | Completed

• 1 other identifier: 2021-K151-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Shoulder Joint Disorder; CKD-MBD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Other: Baduanjin exercise

Control group

NO INTERVENTION

Patients in this group maintain their conventional therapy and daily life activities, and there is no intervention given.

Interventions

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.

Baduanjin exercise group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Yuan, MD

  Affiliated Hospital of Nantong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: February 20, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)