Effect of Integrated Yoga Module on Patients with Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To study the effects of Integrated Yoga Module on Balance, fatigue, Anxiety and Depression in RRMS patients using
研究概览
简要总结
Need for the study in India
Advancement in diagnostic tools and disease awareness, MS increasingly diagnosed in India.
MS not only affects the patient but also affects the patient’s family both mentally and economically.
Yoga interventions used in the previous studies have been heterogenous.
Except Vasudevan et al., 2021 (location Chennai) no other experimental published data is available from our country on the study of yoga in MS.
There is need for region specific studies across various states in India, as a diverse geographic and demographic characteristic of Indian population may impact the effectiveness of yoga Interventions for MS patients, requiring tailored approaches to address these factors.
Therefore, the aim of the study is to make preliminary investigation to rule the feasibility and reliability of effectiveness of integrated yoga module (By Palukuru et al., 2021) for practice in RRMS patient for MS symptoms management and improving quality of life.
Note: The DASS-21 (Depression Anxiety and Stress-21) scale was used instead of HADS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Diagnosed RRMS by Neurologist and in remission.
- •â€¢Written informed concent.
排除标准
- •â€¢Any condition which the investigator feels that the patient is unsuitable.
- •â€¢SPMS, PPMS, PRMS.
- •â€¢Pregnant and lactating women or women planning for pregnancy.
- •â€¢Lever and kidney failure.
- •â€¢Suffering from lung disease.
- •â€¢Suffering from epilepsy or parkinsonism.
- •â€¢Patients with profound cognitive impairment.
- •â€¢Psychiatric or cardiac disorder.
- •â€¢Participation in similar intervention in last 3 months.
结局指标
主要结局
To study the effects of Integrated Yoga Module on Balance, fatigue, Anxiety and Depression in RRMS patients using
时间窗: Baseline, 6 weeks and 12 weeks | post-intervention
1. Balance - Berg Balance Scale (BBS).
时间窗: Baseline, 6 weeks and 12 weeks | post-intervention
2. Fatigue – Fatigue Severity Scale (FSS)
时间窗: Baseline, 6 weeks and 12 weeks | post-intervention
3. Anxiety and Depression – Hospital Anxiety and Depression Scale (HADS).
时间窗: Baseline, 6 weeks and 12 weeks | post-intervention
次要结局
- Physical pain and Quality of Life – Questionnaire MSQoL-54.(Baseline, 6 weeks and 12 weeks)
研究者
Bharti Patel
Gujarat Vidyapith