The Effect of Qigong on Functional Outcomes, Balance, General Well-Being, and Depression in Patients Diagnosed With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The Multiple Sclerosis Impact Scale-29 (MSIS-29)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conventional rehabilitation therapy (Other)
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:
- 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 participate in a 45-minute additional Qigong session (three times a week), led by a physiotherapist, after their conventional rehabilitation program.
干预措施: Qi gong Baduanjin Exercises (Other)
结局指标
主要结局
The Multiple Sclerosis Impact Scale-29 (MSIS-29)
时间窗: 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.
次要结局
- The Berg Balance Scale (BBS)(Before therapy and after therapy (6 weeks))
- Barthel Index(Before therapy and after therapy (6 weeks))
- Beck Depression Inventory (BDI)(Before therapy and after therapy (6 weeks))
研究者
Ozlem Kuculmez
Asist. prof. dr.
Baskent University