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临床试验/NCT07155642
NCT07155642已完成不适用

Effects of Yoga and Conventional Physiotherapy Programs on Fatigue, Balance, Walking and Quality of Life in Multiple Sclerosis Patients.

Istanbul Rumeli University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
MS Walking Scale (MSWS-12)

研究概览

简要总结

Objective

The objective of this study will be to compare the effects of an eight-week Yin-based yoga program and conventional physiotherapy on fatigue, balance, gait, and quality of life in individuals with Multiple Sclerosis (MS).

Methods

Twenty patients with MS will be randomly assigned to either a yoga group (n = 10) or a physiotherapy group (n = 10). Both groups will participate in supervised sessions lasting 60 minutes per day, three days per week, over an eight-week period.

The yoga intervention will be Yin-based, incorporating centering, yoga postures, breathing exercises, and relaxation.

The physiotherapy program will consist of aerobic training, strengthening and spinal stabilization exercises, balance and coordination activities, and stretching.

Outcome measures will include the Fatigue Severity Scale (FSS) for fatigue, the Berg Balance Scale (BBS) for balance, the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for gait, and the Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54) for physical and mental health-related quality of life.

详细描述

Intervention Protocol Yoga Program

The yoga intervention will be implemented in small groups of up to five participants, three times per week for a duration of eight weeks. Sessions will be led by a physiotherapist experienced in working with multiple sclerosis (MS) patients and certified in yoga practice. Each session will last 60 minutes and will consist of four structured components:

Centering/Meditation (5-10 minutes):

Participants will perform breath-focused meditation in a comfortable seated position, using cushions if required. The duration will begin at 5 minutes during the first week and will gradually increase to 8-10 minutes by the third week. Participants will be instructed to count their breaths up to ten, restarting from one if their focus drifts.

Yin and Yang Yoga Poses (40 minutes):

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • •Being between 18-65 years of age.
  • •Voluntarily giving informed consent to participate in the study.
  • •Having either Relapsing-Remitting MS (RRMS) or Secondary Progressive MS (SPMS) type.
  • •An Expanded Disability Status Scale (EDSS) score of 5.5 or below.
  • •No MS exacerbation within the last 4 weeks.
  • •Possessing the willingness, ability, and cognitive intactness to participate in the interventions.

排除标准

  • •Using medication specifically for fatigue.
  • •Presence of major sleep disorders, clinical depression, hypothyroidism, or B12 deficiency.
  • •Severe balance problems (e.g., Central Vestibular Disorders (CVO), peripheral neuropathy, Meniere's disease, vertigo).
  • •Having received corticosteroid treatment within the last 4 weeks.
  • •Pregnancy.
  • •Serious cardiovascular disease, hypertension, or orthopedic limitations.
  • •Presence of Carpal Tunnel Syndrome.

研究组 & 干预措施

yoga

Experimental

Participants in the yoga group received a total of 8 weeks of intervention, conducted 3 days a week, for 60 minutes per day. The program components were:

  • 8 minutes of meditation practice.
  • 40 minutes of Yin and Yang yoga postures. (It's highly recommended to briefly explain what "Yin and Yang yoga postures" specifically entail in the full paper's methodology section, e.g., "Yin yoga focuses on holding passive poses for longer durations to target deep connective tissues, while Yang yoga incorporates more active, flowing sequences to build strength and flexibility.")
  • 2 minutes of breathing exercises (pranayama).
  • 10 minutes of deep relaxation (savasana).

干预措施: yoga (Other)

Conventional Physiotherapy

Active Comparator

Participants in the conventional physiotherapy group also underwent an 8-week program, 3 days a week, for 60 minutes per day. This program included:

  • Aerobic exercises.
  • Stretching exercises.
  • Strengthening exercises.
  • Spinal stabilization exercises.
  • Balance exercises.

干预措施: conventional physiotheraphy (Other)

结局指标

主要结局

MS Walking Scale (MSWS-12)

时间窗: 3 months

The MSWS-12 is a 12-item self-reported questionnaire that assesses the impact of MS on walking ability over the past two weeks. Items are rated on a 5-point scale (1: almost never, 5: extremely). Higher scores indicate greater perceived walking limitations or difficulties

MS Quality of Life-54 (MSQOL-54)

时间窗: 3 months

The MSQOL-54 is a disease-specific quality of life questionnaire for MS patients. It comprises 31 questions divided into three sub-dimensions: psychological, physical, and psychosocial quality of life. Lower scores indicate a higher quality of life

MS Walking Scale (MSWS-12)

时间窗: 3 months

The MSWS-12 is a 12-item self-reported questionnaire that assesses the impact of MS on walking ability over the past two weeks. Items are rated on a 5-point scale (1: almost never, 5: extremely). Higher scores indicate greater perceived walking limitations or difficulties

MS Quality of Life-54 (MSQOL-54)

时间窗: 3 months

The MSQOL-54 is a disease-specific quality of life questionnaire for MS patients. It comprises 31 questions divided into three sub-dimensions: psychological, physical, and psychosocial quality of life. Lower scores indicate a higher quality of life

次要结局

  • Fatigue Severity Scale (FSS)(3 months)
  • Berg Balance Scale (BBS)(3 months)
  • Fatigue Severity Scale (FSS)(3 months)
  • Berg Balance Scale (BBS)(3 months)

研究者

发起方
Istanbul Rumeli University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nursel Oziri

PhD

Istanbul Rumeli University

研究点 (1)

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