Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Qigong, Complementary Therapies
Brief summary
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.
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.
Interventions
OTHERQi gong Baduanjin Exercises
The protocol includes eight traditional movements, such as: * Raising Hands to the Sky (9 repeats) * Drawing the Bow to Hit the Hawk (9 left, 9 right repeats) * Separating Heaven and Earth (9 repeats) * The Wise Owl Looking Back. (9 left, 9 right repeats) * Shaking the Head and Tail (9 left, 9 right repeats) * Bending to Touch the Feet (9 repeats) * Clenching Fists and Gathering Energy with a Fierce Look (9 left, 9 right repeats) * Shaking the Body by Hitting the Heels (9 repeats) Each exercise sequence will be performed with warm-up (deep breathing) and cool-down (focusing on energy flow). The Qigong group will participate in a Qigong session 3 days a week,30-45 minutes, led by a physiotherapist, after their conventional rehabilitation program (3 days a week, with each session lasting 1,5 hours).Breathing in and out will be performed in coordination with qigong movements.
: 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.
Sponsors
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomized controlled clinical trial There are two arms Conventional Rehabilitation Protocol: 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. Chinese Medicine Exercise Protocol: The protocol includes eight traditional movements, such as: * Raising Hands to the Sky, * Drawing the Bow to Hit the Hawk, * Separating Heaven and Earth, * The Wise Owl Looking Back, * Shaking the Head and Tail, * Bending to Touch the Feet, * Clenching Fists and Gathering Energy with a Fierce Look, * Shaking the Body by Hitting the Heels. Each exercise sequence will be performed with warm-up (deep breathing) and cool-down (focusing on energy flow). The Qigong group will
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Multiple Sclerosis Impact Scale-29 (MSIS-29) | before therapy and after therapy (6 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Berg Balance Scale (BBS) | Before therapy and after therapy (6 weeks) | 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. |
| Barthel Index | Before therapy and after therapy (6 weeks) | 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. |
| Beck Depression Inventory (BDI) | Before therapy and after therapy (6 weeks) | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSevgi Ikbali Afsar, Professor
Baskent University Hospital Ankara
Outcome results
None listed