Baduanjin Exercise on Maintenance Hemodialysis Patients
Phase: NA
Conditions: Hemodialysis Complication, Shoulder Joint Disorder, CKD-MBD
Sponsor: Affiliated Hospital of Nantong University

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The Effect of Baduanjin on Shoulder 
Function in Maintenance Hemodialysis 
Patients 
 
Affiliated Hospital of Nantong University 
 
2021-11-30 
 
 

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The Effect of Baduanjin on Shoulder Function in 
Maintenance Hemodialysis Patients  
                                 
 
1.Research Background 
 
Chronic kidney disease bone mineral metabolism disorders exist in maintenance 
dialysis (MHD) patients, with a high incidence of bone and joint pain of 58.7%. At the 
same time, the motor ability of patients with chronic kidney disease decreases as the 
disease progresses, and MD patients gradually experience muscle atrophy, decreased 
upper limb motor ability, slow walking, and slow sitting and standing. Long term lack of 
exercise further exacerbates bone and joint lesions. Studies have shown that exercise 
can improve joint function, alleviate joint pain, increase muscle strength, and improve 
inflammation in MD patients. However, due to the lack of relevant evidence-based 
evidence, exercise rehabilitation has not yet been included in routine clinical care plans. 
Clinical needs for rehabilitation exercise research data suitable for the national 
conditions of MHD patients, in order to recommend reasonable, feasible, and easily 
acceptable exercise methods for the Chinese people. Baduanjin is a health preservation 
technique in ancient China that combines breathing and physical exercise. It is a multi 
element intervention method that integrates physical, psychological, emotional, spiritual, 
and behavioral factors, with moderate exercise volume and belongs to the category of 
aerobic exercise. Although studies have suggested that Baduanjin has a good 
rehabilitation treatment effect in people with shoulder joint dysfunction, there is still a 
lack of application data in MHD patients. This study aims to follow evidence-based 
medicine methods to observe the improvement of shoulder joint function in 
maintenance dialysis patients using Baduanjin, providing theoretical basis and data 
support for the exercise rehabilitation and personalized treatment of MHD patients. 
References 
1. Zhang L, Fang W, Wang L, et al. Prevalence of chronic kidney disease in China: 
a cross-sectional survey. Lancet 2012; 380: 214-214. 
2. Roshanravan B, Gamboa J and Wilund K. Exercise and CKD: Skeletal Muscle 
Dysfunction and PracticalApplication of Exercise to Prevent and Treat Physical 
Impairments in CKD. American Journal of Kidney Diseases2017: 837-852. 
3. Zelle DM, Klaassen G, Adrichem EV, et al. Physical inactivity: a risk factor and 
target for intervention in renal care. Nature Reviews Nephrology 2017; 13: 152-168. 

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4. Zhang H, Qian YL, Li C, et al. Brain-Derived Neurotrophic Factor in the 
Mesolimbic Reward Circuitry Mediates Nociception in Chronic Neuropathic Pain. 
Biological Psychiatry 2017: S0006322317313537. 
 
2.Research Content 
2.1 Research Purpose  
Main objective: To observe the effect of Baduanjin on the shoulder joint function of 
maintenance dialysis patients. 
Secondary objective: To observe the effect of Baduanjin on the quality of life and 
emotions of MHD patients. 
2.2 Study 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. 
2.3 Grouping 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 

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 Individuals with primary or secondary muscle diseases, mental abnormalities, lack 
of autonomous behavior ability, and lack of cooperation with clinical observation and 
treatment. 
2.4 Outcome Measures 
Primary Outcome Measure: 
1) 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). 
2) 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. 
3) 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. 
4) Area of biceps brachii muscle 
Measure the thickness of the biceps brachii muscle in two groups of patients through 
skeletal muscle ultrasound examination. 
Secondary Outcome Measures: 
1) 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 

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higher scores indicating better health status. 
2) 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. 
 
2.5 Statistical analysis, confidentiality plan 
In terms of statistical analysis, SPSS 23.0 statistical software is used to establish 
a database and perform statistical processing. Descriptive statistical analysis, 
qualitative indicators are described as percentages, and quantitative indicators are 
described as mean ± standard deviation. The data is subjected to normality testing and 
corresponding testing methods are adopted based on whether it follows a normal 
distribution. Qualitative data comparison adopts chi square test. Quantitative data 
conforms to normal distribution, t-test is used for comparison between two groups, and 
nonparametric test is used for abnormal distribution and P<0.05 is considered 
statistically significant. 
 
2.6 Preservation and Confidentiality of Information 
The researcher preserves all research data, including confirmation of all 
participants (able to effectively verify different record materials, such as hospital original 
records), all original informed consent forms with subject signatures, all case 
observation forms, detailed records of evaluation indicators, etc. 
The results of this project may be published in medical journals, but we will keep the 
information of the subjects confidential in accordance with legal requirements. Unless 
required by relevant laws, the personal information of the subjects will not be disclosed. 
When necessary, research supervision and management departments, hospital ethics 
committees and their relevant personnel may access patient information in accordance 
with regulations. 
 
3. Exit and Termination Criteria 
1) Those who do not receive regular exercise guidance from doctors, which affects the 
accuracy and effectiveness of research; 
2) Those who experience adverse events and are not suitable for further observation; 
The doctor determines that it is not suitable to continue observing the patient; 

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3) The subject experiences certain serious complications or complications, death or 
loss of follow-up, and is deemed unsuitable for further observation by the doctor; 
4) During the research process, participants experienced endpoint events such as 
cardiovascular and cerebrovascular events and death. 
 
 
4 Ethical issues 
4.1 Ethical Approval 
This clinical research protocol complies with the relevant provisions of the Helsinki 
Declaration regarding the protection of subject rights.This protocol, written informed 
consent form, and materials directly related to the subjects must be submitted to the 
ethics committee for written approval before the study can be officially conducted. If this 
protocol has been revised during the clinical research implementation process, it must 
be submitted to the ethics committee for approval before implementation, and these 
changes cannot be implemented without the approval of the ethics committee, unless 
they are made to eliminate obvious and direct risks to the subjects. When such 
situations occur, they will be reported to the ethics committee. If important new 
information related to the study is found, the informed consent form must be modified 
in writing and submitted to the ethics committee for approval before obtaining the 
consent of the subjects again. Each clinical research center agrees that before the start 
of this research project, the ethics committee of the team leader unit shall review the 
research plan. The ethics committees of each sub center may choose to file or review 
it themselves. If necessary (such as serious adverse events or protocol violations), the 
ethics committees of each center shall convene a meeting in a timely manner for review 
and report the review conclusions to the ethics committees of other centers. 
4.2 Informed consent 
The researcher must provide the subject or their legal representative with an easily 
understandable and approved informed consent form by the ethics committee, 
providing the subject or their legal representative with a complete and comprehensive 
explanation of the detailed information related to the clinical study, including the 
research purpose, research procedures, potential benefits and risks, subject rights and 
obligations, etc., and letting the patient know that they have the right to withdraw from 
the study at any time, After ensuring that patients fully understand and have sufficient 
time to consider and receive satisfactory responses to the questions raised, they agree 
and sign an informed consent form before starting clinical research. During the 

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participant period, all updated versions of the informed consent form and written 
information will be provided to the participants. The informed consent form should be 
kept as an important document in clinical research for future reference. 
 
 
5.Principal investigator 
Yuan Li  Affiliated Hospital of Nantong University，yuanlint@163.com 
Zhang Yuan   Affiliated Hospital of Nantong University，49260183@qq.com 
Shi Zhaoyu   Affiliated Hospital of Nantong University，15251307956@163.com