Development and feasibility of integrated yoga therapy module for patients suffering with Multiple sclerosis. A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CCRYN
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To develop an Integrated Yoga Module for patients diagnosed with mild to moderate symptoms of relapsing remitting multiple sclerosis and who is ambulatory.
研究概览
简要总结
Multiple sclerosis (MS) is the most common autoimmune inflammatory demyelinating disease of the central nervous system leading to severe disability. A wide range of symptoms can cause significant functional limitations leading to poor quality of life. Pharmacological treatments are symptomatic and delay the progression of disability. Their role is limited in reversing mobility disability or restoring ambulatory function in persons with MS. In recent years more individuals with MS have been pursuing complementary and alternative medicine (CAM) to manage symptoms of the disease and Yoga is the most popular one in use. Studies have suggested yoga to be a holistic, cost-effective safe and potential intervention in the management of MS. However, there is no clear guideline or specific yoga module designed for MS in the literature. In this context, we intend to develop a yoga module that is safe and effective for MS and study its feasibility in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •A diagnosis of CDMS clinically defined multiple sclerosis using revised McDonald criteria 2010 2017 revision).
- •Relapsing-remitting multiple sclerosis Minimum education with the ability to read and write Consent to take part in the study EDSS Expanded Disability Status Scale score between 0 and 6 On stable medication for at least 6 weeks.
排除标准
- •Any condition which the investigator feels that the patient is unsuitable.
- •Patients with Progressive course which resulted in early disability.
- •Patients of Expanded Disability Status Scale (EDSS) score 7 and above Patients with Mini-Mental State Examination (MMSE) score more than or equal to
- •Women with h/o of menorrhagia Dysfunctional uterine bleeding.
- •Neurological disorders (Epilepsy and Parkinsonism) and other neuro-degenerative disorders with MS complex.
- •Patients with substance dependence (except nicotine).
- •Pregnant and lactating women or women planning for pregnancy.
- •Patients with uncontrolled Type 2 Diabetes mellitus (FBS >126 mg/dl PPBS > 200 mg/dl.
- •Subjects on β-blockers thiazide diuretics corticosteroids HRT.
- •Subjects with Uncontrolled Hypertension (with or without medication).
- •Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S.Creatinine > greater than ULL) uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).
- •Patients with evidence of malignancy.
- •Patients with recent H/O fever.
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis Psycho-Neuroendocrinal disorders etc.) Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Practice of a structured yoga module in the past 3 months (three or more times per week) prior to the study.
结局指标
主要结局
To develop an Integrated Yoga Module for patients diagnosed with mild to moderate symptoms of relapsing remitting multiple sclerosis and who is ambulatory.
时间窗: Baseline,10 days,1 month
To study its feasibility and acceptability in this population.
时间窗: Baseline,10 days,1 month
次要结局
- Not applicable(NA)