RehabilitationNCT06346379
The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients
A study testing Baduanjin exercise in people with Rehabilitation and Physical Fitness, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rehabilitation, Physical Fitness, Bone Density
- What is being tested?
- Baduanjin exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old;
- Having received MHD treatment in this dialysis center for more than 3 months and maintaining stable condition;
- Having normal comprehension ability, clear verbal expression, informed consent and willingness to participate in this study.
- Having free movement ability, and being able to tolerate Baduanjin exercise after cardiopulmonary exercise test;
- Right-handed, with fistula in the non-dominant hand;
Who cannot join
- Patients who usually practice traditional Chinese medicine exercises such as tai chi;
- Patients who are recently complicated with severe infections, active malignant tumors, severe cardiopulmonary insufficiency, gastrointestinal bleeding, nervous system diseases and cannot tolerate exercise;
- Patients with various orthopedic, neurological, and other diseases that cause muscle and joint deformities that affect grip strength measurement;
- Patients with senile dementia, hearing impairment, comprehension abnormalities, mental disorders, unclear verbal expression or unwilling to participate in this study;
- 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;
- Patients who are participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Li Yuan, 0086-051381168416, yuanlint@163.com
Yuan Zhang, 0086-051381168411, 49260183@qq.com
About this study
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.
Read the 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.
- Being tested
- Baduanjin exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exerciseBehavioural
Baduanjin has 8 movement forms, which are easy to learn without special equipment.These advantages make Baduanjin a suitable exercise 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.During the exercise of Baduanjin, the knees are half bent and the body center of gravity is stable between the feet, which can effectively develop the strength and endurance of skeletal muscle groups, improving the physical fitness and Bone mineral density.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercise | 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 Baduanjin practice, and 5 minutes of cool-down exercises. Receives: Behavioral: Baduanjin exercise |
| Control group | No intervention | Patients in this group maintain their conventional therapy and daily life activities, and there is no intervention given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength measurement
Grip strength can reflect the strength of hand muscles. The grip strength of both hands of patients was measured using a domestic gripper.The patient took an upright position and grasped the handle with the maximum force. When the display on the machine stopped changing, the value was recorded. The test was repeated three times, and the maximum value was taken to record the results.
Measured: 0 month, 6month, 12month，18month
Five-times Sit-to-Stand Test (FTSST)
The five-times sit-to-stand test is used to evaluate the functional strength of the lower limbs. MHD patients sat on a 46cm chair without armrests, with their feet on the ground and their backs not resting on the chair. Their hands were crossed on their shoulders. They stood up from the chair as quickly as possible without arm support. They completed five sitting and standing movements, and the completion time was recorded.During the test, the patient kept his hands crossed and his knees completely straightened.Three tests were completed, with a one-minute rest between tests. The average value of the three tests was statistically analyzed.
Measured: 0 month, 6month, 12month，18month
Timed "up and go" test (TUGT)
The timed "up and go" test is often used to evaluate functional mobility such as balance and walking required in daily life.MHD patients were seated in a back chair with armrests (the seat was about 46cm high, and the armrest was about 21cm high). A guide line was placed on the ground 3m away from the chair. After the test began, the patient left the chair, stood firmly and walked forward for 3m as fast as possible, crossed the guide line, turned around, and returned to the chair to sit down. The walking aids were not allowed during the test.The test was conducted 3 times in total, with a 1-minute rest between adjacent tests. The average value of the 3 tests was taken for statistical analysis.
Measured: 0 month, 6month, 12month，18month
The sitting forward flexion test
The sitting forward flexion test is often used to evaluate the flexibility of the lower limbs of patients.The patient straightened the knee joint, sat on the flat ground with both feet flat on the test board, bent forward, straightened both arms forward, and gradually pushed the cursor with both middle fingertips to the farthest possible distance.The measuring device was 0 point along the plane of the foot pedal board, negative inward, positive forward, in centimeters. The knee joint could not be bent during the test, and sudden force could not be applied.The test was conducted 3 times in total, and the best result was taken for statistical analysis.
Measured: 0 month, 6month, 12month，18month
The Standing on one-leg with eyes closed test (SOLECT)
The Standing on one-leg with eyes closed test evaluates the stability of the static posture by quantitative measurement, reflecting the balance ability of patients.The patient spread both hands, closed his eyes, and stood on one leg, with the other leg bent so that the angles between the two legs were 90 degrees. Time was recorded from the time when the foot left the ground, and the shaking stopped when the foot left the ground or stood up. The average of the three times was used for statistical analysis.
Measured: 0 month, 6month, 12month，18month
Bone mineral density test
The signals received by the scanning system after the double-energy DXA line penetrated the body were transmitted to the supporting software to calculate the average bone mineral density content (g/cm2) of the whole body, the left femur Ward triangle area, and the lumbar spine (L2~L4).
Measured: 0 month, 6month, 12month，18month
Secondary outcomes (2)
Changes in the Short Form-36(SF-36)
Changes from the Short Form-36 (SF-36) and European Quality of Life Five Dimension（EQ-5D-5L）scale at 0 months, 6 months, 12 months. The SF-36 score is used to evaluate an individual's health status and quality of life. The SF-36 score expressed as a number between 0 and 100, with higher numbers indicating better health.
Measured: 0 month, 6month, 12month，18month
Changes in the Hospital Anxiety and Depression Scale （HADS）
Changes from HADS Index at at 0 months, 6 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.
Measured: 0 month, 6month, 12month，18month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Yuan, Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346379
- Sponsor's protocol ID
- 2023-K086-01
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared after request
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06346379
- Acronym / sponsor ID
- 2023-K086-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercise | Experimental | Behavioral: Baduanjin exerciseBefore 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 Baduanjin practice, and 5 minutes of cool-down exercises. |
| Control group | No intervention | –Patients in this group maintain their conventional therapy and daily life activities, and there is no intervention given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years old;
- Having received MHD treatment in this dialysis center for more than 3 months and maintaining stable condition;
- Having normal comprehension ability, clear verbal expression, informed consent and willingness to participate in this study.
- Having free movement ability, and being able to tolerate Baduanjin exercise after cardiopulmonary exercise test;
- Right-handed, with fistula in the non-dominant hand;
Key exclusion criteria (6 listed)
- Patients who usually practice traditional Chinese medicine exercises such as tai chi;
- Patients who are recently complicated with severe infections, active malignant tumors, severe cardiopulmonary insufficiency, gastrointestinal bleeding, nervous system diseases and cannot tolerate exercise;
- Patients with various orthopedic, neurological, and other diseases that cause muscle and joint deformities that affect grip strength measurement;
- Patients with senile dementia, hearing impairment, comprehension abnormalities, mental disorders, unclear verbal expression or unwilling to participate in this study;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin exerciseBaduanjin has 8 movement forms, which are easy to learn without special equipment.These advantages make Baduanjin a suitable exercise 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.During the exercise of Baduanjin, the knees are half bent and the body center of gravity is stable between the feet, which can effectively develop the strength and endurance of skeletal muscle groups, improving the physical fitness and Bone mineral density. | Behavioural | Baduanjin exercise |
Primary outcome
Muscle strength measurement
Time frame: 0 month, 6month, 12month，18month
Grip strength can reflect the strength of hand muscles. The grip strength of both hands of patients was measured using a domestic gripper.The patient took an upright position and grasped the handle with the maximum force. When the display on the machine stopped changing, the value was recorded. The test was repeated three times, and the maximum value was taken to record the results.
Five-times Sit-to-Stand Test (FTSST)
Time frame: 0 month, 6month, 12month，18month
The five-times sit-to-stand test is used to evaluate the functional strength of the lower limbs. MHD patients sat on a 46cm chair without armrests, with their feet on the ground and their backs not resting on the chair. Their hands were crossed on their shoulders. They stood up from the chair as quickly as possible without arm support. They completed five sitting and standing movements, and the completion time was recorded.During the test, the patient kept his hands crossed and his knees completely straightened.Three tests were completed, with a one-minute rest between tests. The average value of the three tests was statistically analyzed.
Timed "up and go" test (TUGT)
Time frame: 0 month, 6month, 12month，18month
The timed "up and go" test is often used to evaluate functional mobility such as balance and walking required in daily life.MHD patients were seated in a back chair with armrests (the seat was about 46cm high, and the armrest was about 21cm high). A guide line was placed on the ground 3m away from the chair. After the test began, the patient left the chair, stood firmly and walked forward for 3m as fast as possible, crossed the guide line, turned around, and returned to the chair to sit down. The walking aids were not allowed during the test.The test was conducted 3 times in total, with a 1-minute rest between adjacent tests. The average value of the 3 tests was taken for statistical analysis.
The sitting forward flexion test
Time frame: 0 month, 6month, 12month，18month
The sitting forward flexion test is often used to evaluate the flexibility of the lower limbs of patients.The patient straightened the knee joint, sat on the flat ground with both feet flat on the test board, bent forward, straightened both arms forward, and gradually pushed the cursor with both middle fingertips to the farthest possible distance.The measuring device was 0 point along the plane of the foot pedal board, negative inward, positive forward, in centimeters. The knee joint could not be bent during the test, and sudden force could not be applied.The test was conducted 3 times in total, and the best result was taken for statistical analysis.
The Standing on one-leg with eyes closed test (SOLECT)
Time frame: 0 month, 6month, 12month，18month
The Standing on one-leg with eyes closed test evaluates the stability of the static posture by quantitative measurement, reflecting the balance ability of patients.The patient spread both hands, closed his eyes, and stood on one leg, with the other leg bent so that the angles between the two legs were 90 degrees. Time was recorded from the time when the foot left the ground, and the shaking stopped when the foot left the ground or stood up. The average of the three times was used for statistical analysis.
Bone mineral density test
Time frame: 0 month, 6month, 12month，18month
The signals received by the scanning system after the double-energy DXA line penetrated the body were transmitted to the supporting software to calculate the average bone mineral density content (g/cm2) of the whole body, the left femur Ward triangle area, and the lumbar spine (L2~L4).
2 secondary outcomes
Changes in the Short Form-36(SF-36)
Time frame: 0 month, 6month, 12month，18month
Changes in the Hospital Anxiety and Depression Scale （HADS）
Time frame: 0 month, 6month, 12month，18month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No. Data can be shared after request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Yuan study chair
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise in people with Rehabilitation and Physical Fitness, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yuan (0086-051381168416, yuanlint@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength measurement (time frame: 0 month, 6month, 12month，18month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.