- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473180
Effects of Qigong Therapy in MS Patients
The Effect of Qigong on Functional Outcomes, Balance, General Well-Being, and Depression in Patients Diagnosed With Multiple Sclerosis
Chinese medical exercises (Qigong) are part of traditional Chinese medicine and martial arts, consisting of exercise sequences originating from China. These exercises have been used in China for thousands of years to maintain physical and psychological health and treat diseases. They have increasingly become a focus of modern medicine. Qigong is a practice that integrates concentration, visualization, breathing, posture, and movement techniques. Its goal is to enhance, activate, develop, and balance life energy (Qi).
Study Type: Randomized controlled clinical trial. Upon reviewing the literature, no study was found comparing the practical application of Qigong exercises with conventional rehabilitation methods. This study aims to investigate the effects of Qigong on the overall well-being and balance of Multipl Sklerosis patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION AND GENERAL INFORMATION Chinese medical exercises (Qigong) are part of traditional Chinese medicine and martial arts, consisting of exercise sequences originating from China. These exercises have been used in China for thousands of years to maintain physical and psychological health and treat diseases. They have increasingly become a focus of modern medicine. Qigong is a practice that integrates concentration, visualization, breathing, posture, and movement techniques. Its goal is to enhance, activate, develop, and balance life energy (Qi).
Many neurological diseases, which are the focus of Physical Medicine and Rehabilitation specialists, reduce the quality of life of patients due to chronic disability and dependency, along with associated psychosocial disorders such as anxiety and depression. The goal of neurological rehabilitation, which aims to achieve "optimal biopsychosocial well-being", aligns with the objectives of mind-body medicine. Indeed, the components of mind-body medicine are frequently used in neurological rehabilitation today.
Upon reviewing the literature, no study was found comparing the practical application of Qigong exercises with conventional rehabilitation methods in MS. This study aims to investigate the effects of Qigong on the overall well-being and balance of MS patients.
MATERIALS AND METHODS Study Type: Randomized controlled clinical trial. Sample: Patients visiting the Physical Medicine and Rehabilitation outpatient clinic at Başkent University, who are enrolled in a rehabilitation program and consent to participate, will be included.
The minimum required sample size for the "Student's t-test" to achieve 80% power with a 95% confidence level is n=128 (64 in the Qigong group and 64 in the control group). For "Repeated Measures ANOVA," the minimum required sample size is n=148 (74 in each group).
Thus, the total minimum sample size for the study is 148 participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Baskent University Medical faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-65 years, diagnosed with MS according to McDonald criteria,
- Expanded Disability Status Scale (EDSS) ≤5, able to walk independently or with minimal assistance,
- No relapse or treatment changes in the last 30 days.
Exclusion Criteria:
- Participation in a mixed exercise program containing traditional Chinese exercises (Tai Chi, Qigong, Yoga, etc.) in the past 3 months,
- Severe cardiopulmonary or musculoskeletal problems that could contraindicate traditional Chinese exercises,
- Communication barriers due to cognitive issues,
- Progressive comorbid conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Therapy
Patients in the conventional rehabilitation group will participate in a rehabilitation program at least 3 days a week, with each session lasting 1.5 hours.
The program will include neurophysiological exercises, strengthening exercises, and balance and coordination exercises, performed in three sets of 10 repetitions.
There will be warm-up and cool-down periods before and after each session.
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: Patients in the conventional rehabilitation group will participate in a rehabilitation program 3 days a week, with each session lasting 1.5 hours.
The program will include neurophysiological exercises, strengthening exercises, and balance and coordination exercises, performed in three sets of 10 repetitions.
There will be warm-up and cool-down periods before and after each session.
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Experimental: Qi gong
This group will take 3 times a week Qi gong therapy with classical conventional therapy. The protocol includes eight traditional movements, such as:
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The protocol includes eight traditional movements, such as:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time Frame: before therapy and after therapy (6 weeks)
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The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a widely used, patient-reported questionnaire designed to assess the physical and psychological impact of multiple sclerosis (MS) on an individual's daily life.
Developed by Hobart and colleagues in 2001, the MSIS-29 consists of 29 items divided into two subscales: 20 items addressing the physical impact of MS and 9 items evaluating the psychological impact.
Each item is rated on a 5-point Likert scale ranging from "not at all" to "extremely," and the total scores are transformed to a 0-100 scale, where higher scores indicate greater impact.
The MSIS-29 is valued for its reliability, sensitivity to change, and ease of use in both clinical practice and research settings.
It provides a comprehensive view of how MS affects a patient's quality of life.
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before therapy and after therapy (6 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Berg Balance Scale (BBS)
Time Frame: Before therapy and after therapy (6 weeks)
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The Berg Balance Scale (BBS) is a widely used clinical tool designed to assess a person's balance and risk of falling, particularly in older adults and individuals with balance impairments due to neurological conditions such as stroke, multiple sclerosis, or Parkinson's disease.
It consists of 14 simple tasks that measure both static and dynamic balance abilities, including activities such as standing up from a sitting position, standing with eyes closed, turning, and reaching forward.
Each task is scored on a 5-point scale (0 to 4), where 0 indicates inability to perform and 4 indicates independent and safe performance, resulting in a maximum total score of 56.
Lower scores indicate greater balance impairment and a higher risk of falls.
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Before therapy and after therapy (6 weeks)
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Barthel Index
Time Frame: Before therapy and after therapy (6 weeks)
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The Barthel Index is a standardized tool used to assess a person's ability to perform basic activities of daily living (ADLs) independently.
It is commonly used in rehabilitation settings, especially for individuals recovering from stroke, spinal cord injuries, or other conditions affecting physical functioning.
The index evaluates 10 daily activities, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers (e.g., from bed to chair), mobility, and stair climbing.
Each activity is scored based on the level of assistance required, with total scores typically ranging from 0 to 100, where higher scores indicate greater independence.
A score of 100 means the individual is fully independent, while lower scores reflect varying levels of dependency.
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Before therapy and after therapy (6 weeks)
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Beck Depression Inventory (BDI)
Time Frame: Before therapy and after therapy (6 weeks)
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The Beck Depression Inventory (BDI) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in adolescents and adults.
Each item is scored on a scale from 0 to 3, with higher scores indicating more severe depressive symptoms.
The total score helps classify depression severity as minimal, mild, moderate, or severe.
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Before therapy and after therapy (6 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sevgi Ikbali Afsar, Professor, Baskent University Hospital Ankara
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Okuculmez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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