Efficacy of a Customized Yoga Therapy Module for People Living with Early Parkinsonism - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
- 试验地点
- 8
- 主要终点
- The primary outcome measure would be MDS-UPDRS motor and non-motor functions. The secondary outcome measures will be cognitive scores by Addenbrooks outcome of Quality of life measured by the Parkinsons disease rating scale,Quality of Sleep, postural imbalance, and the gastro intestinal dysfunction on the first month, at the end of 3 months and 6 months. Adverse effects will also be noted in both groups by the PI
研究概览
简要总结
Efficacy of a Customized Yoga Therapy Module for People Living With Early Parkinsonism—A Controlled Clinical Trial
Today yoga and its therapy are used widely in modern medicine as an adjuvant therapy. Our study, "Efficacy of a Customized Yoga Therapy Module for People Living With Early Parkinsonism—A Controlled Clinical Trial" focuses on improving the health of the geriatric population, especially those who suffer from the early stages of H&YI-III stage Parkinsonism disease. This research project is an interventional study using a cluster sampling method without randomization, conducted as a controlled clinical trial involving 130 participants (65:65) in stages 1-3 of Hoehn and Yahr over a six-month intervention period.
Study populations are from the aged homes of Mangalore city and the geriatric trusts aged between 45 and 80. Initially, a medical camp will be conducted to screen the PD population in the aged homes as well as in the trust. The Department of Geriatric Medicine, Yenepoya Medical College Hospital, will carry out this PD screening test. The study will be explained clearly to the participants with detailed information and we get their voluntariness and willingness to participate in the study with the consent form signature. The selected potential persons from the initial to intermediate stages will be divided into study and control groups, 65:65, using the cluster sampling method as per inclusion and exclusion criteria. No randomization is applied. There will not be any change in the intake of medicines, and the adverse effects of the dosage changes and other health complaints will be noted during the study period. One hour of customized yoga therapy practice 5 days a week for 6 months will be gradually given week- and month-wise for the interventional group. Both groups will be given a series of geriatric physiotherapy movements for their everyday practices as a standard of care. There will be three interventions: the initial/first month, the intermediate/third month, and the final/sixth month, and the data will be collected accordingly and analyzed statistically. A p-value <0.05 will be considered statistically significant.
Data will be collected using the International Movement Disorder Society questionnaires and other related questionnaires. Since the MDS-UPDRS questionnaires were generated, and permission was received from them, data will be shared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •People with Idiopathic and vascular Parkinsonism aged b/w 55 – 80 are included.
- •Only 1-3 Hoehn &Yahr staging scale of early Parkinsonism who are able to be independent in doing their activities.
- •Able to give written consent and to understand instruction and synchronize the practices, even though aged signs and symptoms are present.
排除标准
- •People with other secondary Parkinsonism, acute disease and disorders, major surgery within two months, practicing already yoga, severe falling episodes and suffering from mental health disorders will be excluded from the study.
结局指标
主要结局
The primary outcome measure would be MDS-UPDRS motor and non-motor functions. The secondary outcome measures will be cognitive scores by Addenbrooks outcome of Quality of life measured by the Parkinsons disease rating scale,Quality of Sleep, postural imbalance, and the gastro intestinal dysfunction on the first month, at the end of 3 months and 6 months. Adverse effects will also be noted in both groups by the PI
时间窗: 6 months of Yoga therapy intervention
次要结局
- The practice of yoga disciplines, strengthens, quietens, and relaxes your body and mind.(You gain good balance, flexibility, mobility, and postural stability. Improved sleep and reduced stress and anxiety. Good cognitive function is seen within a few months of practice. Even the control group is taken care of by providing Physiotherapy stretches.)
研究者
A Lourdu Mary
Yenepoya Deemed to be University