The effectiveness of modified yoga techniques in improving clinical and psychosocial parameters among adults with Autoimmune Myasthenia Gravis A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- 1. The Quality of Life of patients with Autoimmune Myasthenia Gravis measured by Myasthenia Gravis Quality of Life 15 (MG-QoL15) scale
研究概览
简要总结
This is a Collaborative study ( RCT) will be done on the part of PhD study of Department of Swasthavritta, Government Ayurveda College Tripunithura ( study centre) with Department of Neurology Sree Chitra Tirunal Institute of Medical Sciences and Technology Thiruuananthapram ( Collaborating centre). 70 participants with Auto immune Myasthenia Gravis, satisfying inclusion and exclusion criteria will be selected from SCTIMST by consecutive sampling and online Yoga sessions will be done at Government Ayurveda College Tripunithura. The 70 participants will be allocated to Study and Control group, 35 in each group, by SNOSE randomization. Concealed allocation and randomization will be done on the day of recruitment by the PhD scholar . All the subjects will have a unique code the key to which will be kept with PhD scholar. Both groups will be suggested to follow their conventional treatment and in addition to that the study group will be received 3month online yoga practices . There will be two sessions , morning and evening. only 3-5 participants will be selected for one session. Total study duration is 4 years .
The primary outcomes are QOL15r and FSS scale will be assessed on 0th and 91st day directly at SCTIMST and on 45th day by online questionnaire filled by patient. The secondary outcomes are HADS ,Perceived Stress Scale, ( assessment 0th 45th and 91st day ) and QMG, MGC, MG-ADL, STOP BANG and other Structured questionnaires will be assessed on 0th and 45th day of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with class II MG, II a MG, II b MG, III MG, III a MG, III b MG, IV MG, IV a MG, clinical classification of the Myasthenia Gravis Foundation of America (MGFA)
- •Patient with mild and moderate QMG score
- •MG-ADL more than 2score
- •Myasthenia Gravis patient complaints with Fatigue
- •Subject within the age group 20 to 60 years in both sex
- •Patients willing for regular follow up and evaluation during the period of study
- •Dose of immunotherapy stable in last 2 months prior to recruitment.
排除标准
- •Pregnant woman and lactating mother
- •Patients having malignancy, severe systemic illness, COPD
- •Patient unable to perform yoga postures from minimum required yoga procedure
- •Patients who are not giving consent.
结局指标
主要结局
1. The Quality of Life of patients with Autoimmune Myasthenia Gravis measured by Myasthenia Gravis Quality of Life 15 (MG-QoL15) scale
时间窗: Study Duration 4 years. Assessment will be done on 0th and 91st day of the study.
2. Fatigue of patients with Autoimmune Myasthenia Gravis measured by Fatigue Severity Scale (FSS)
时间窗: Study Duration 4 years. Assessment will be done on 0th and 91st day of the study.
次要结局
- The anxiety and depression of patients with Autoimmune Myasthenia Gravis measured by HADS scale and stress by Perceived stress scale(Assessment will be done on 0th day, 45th day and 91st day of the study.)
- Sleep apnea in patients with Autoimmune Myasthenia Gravis measured by STOP-BANG Sleep Apnea Questionnaire(0th and 91st day of the study)
- Activities of Daily Living (MG-ADL), MG QMG score, Myasthenia Gravis Composite (MGC)(0th and 91st of the study)
- Relapse rate, Frequency of infection and Reducing steroid doses in these subjects by standard questionnaire in patients with Autoimmune Myasthenia Gravis(0th 45th and 91st day of the study)
研究者
Dr Renjumol VS
Government Ayurveda College Tripunithura