Clinical trial NCT06346379: The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients
Official title: The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Physical Fitness
Bone Density
Hemodialysis Complication
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 50
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 physical fitness and bone density in maintenance hemodialysis (MHD) patients. 50 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 physical fitness and bone density in MHD patients. A total of 50 MHD patients will be included and randomized into an intervention group of 25 cases and a control group of 25 cases. The intervention group undergo 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 three days a week, while the control group maintain routine treatment and daily activities. Measure the indicators of each group at baseline, months 6, 12,18. The evaluation of physical fitness is based on the scores (which include muscle strength measurement; five-times sit-to-stand test; timed "up and go" test; sitting forward flexion test; standing on one-leg with eyes closed test ). The bone mineral density test is based on the result of the double-energy DXA line. 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:

1. Age between 18 and 75 years old;
2. Having received MHD treatment in this dialysis center for more than 3 months and maintaining stable condition;
3. Having normal comprehension ability, clear verbal expression, informed consent and willingness to participate in this study.
4. Having free movement ability, and being able to tolerate Baduanjin exercise after cardiopulmonary exercise test;
5. Right-handed, with fistula in the non-dominant hand;

Exclusion Criteria:

1. Patients who usually practice traditional Chinese medicine exercises such as tai chi;
2. Patients who are recently complicated with severe infections, active malignant tumors, severe cardiopulmonary insufficiency, gastrointestinal bleeding, nervous system diseases and cannot tolerate exercise;
3. Patients with various orthopedic, neurological, and other diseases that cause muscle and joint deformities that affect grip strength measurement;
4. Patients with senile dementia, hearing impairment, comprehension abnormalities, mental disorders, unclear verbal expression or unwilling to participate in this study;
5. Patients with hemoglobin \<70g/L, carbon dioxide binding capacity \<13mmol/L, and blood potassium \>6.5mmol/L in laboratory tests and no significant improvement after treatment;
6. Patients who are participating in other clinical studies.

Primary outcomes:
measure: Muscle strength measurement
timeFrame: 0 month, 6month, 12month，18month
measure: Five-times Sit-to-Stand Test (FTSST)
timeFrame: 0 month, 6month, 12month，18month
measure: Timed "up and go" test (TUGT)
timeFrame: 0 month, 6month, 12month，18month
measure: The sitting forward flexion test
timeFrame: 0 month, 6month, 12month，18month
measure: The Standing on one-leg with eyes closed test (SOLECT)
timeFrame: 0 month, 6month, 12month，18month
measure: Bone mineral density test
timeFrame: 0 month, 6month, 12month，18month
Secondary outcomes:
measure: Changes in the Short Form-36(SF-36)
timeFrame: 0 month, 6month, 12month，18month
measure: Changes in the Hospital Anxiety and Depression Scale （HADS）
timeFrame: 0 month, 6month, 12month，18month
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
role: STUDY_CHAIR
References: