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

January 10, 2025 updated by: Affiliated Hospital of Nantong University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226000
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Patients in this group maintain their conventional therapy and daily life activities, and there is no intervention given.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0 month, 6month, 12month，18month
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.
0 month, 6month, 12month，18month
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.
0 month, 6month, 12month，18month
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.
0 month, 6month, 12month，18month
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.
0 month, 6month, 12month，18month
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).
0 month, 6month, 12month，18month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the Short Form-36(SF-36)
Time Frame: 0 month, 6month, 12month，18month
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.
0 month, 6month, 12month，18month
Changes in the Hospital Anxiety and Depression Scale （HADS）
Time Frame: 0 month, 6month, 12month，18month
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.
0 month, 6month, 12month，18month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital of Nantong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Li Yuan, Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-K086-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared after request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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