The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients

NCT ID: NCT06346379

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Rehabilitation Physical Fitness Bone Density Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baduanjin exercise

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.

Group Type EXPERIMENTAL

Baduanjin exercise

Intervention Type BEHAVIORAL

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Baduanjin exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Yuan

Role: STUDY_CHAIR

Affiliated Hospital of Nantong University

Locations

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Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Yuan

Role: CONTACT

0086-051381168416

Yuan Zhang

Role: CONTACT

0086-051381168411

Facility Contacts

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Li Yuan

Role: primary

0086-051381168416

Yuan Zhang

Role: backup

0086-051381168411

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2023-K086-01

Identifier Type: -

Identifier Source: org_study_id

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