Effect of Yoga on psychological, cognitive and glycemic control in patients with T2DM and Depression: Two arm parallel 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
- 320
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Yoga on depression in patients with T2DM
研究概览
简要总结
The studywill assess effect of yoga and meditation on depression, anxiety, diabetesrelated distress, cognitive deficits, glycemic control and metabolic riskfactors in patients with Type 2 diabetes who have comorbid depression atbaseline. The study is a randomized controlled trial with parallel arm comparator[prescription of 30 minutes of walking]. The study has been powered to 90% todetect even 10% difference in depression scores between the two arms. The studyhas a component of intervention phase of 4 months in which yoga will be taughtand supervised by Yoga therapists and a component of sustainability phase, inwhich the patients will have no further supervised yoga sessions. Since, thisstudy is pragmatic in nature, we will see whether there is benefit of yoga onmultiple domains in diabetes after intervention phase. The aim ofsustainability phase will evaluate whether the effects can be sustained aftersupervision is over. The end of 8 months evaluation will help in knowing themedium term effects of yoga.
Thecurrent study will do comprehensive assessment of cognitive deficits bypsychological tests. This sort of comprehensive work has never been done beforeglobally.
Thebroader aim of this study is to have deeper understanding of yoga in Type2 diabetes, and then subsequently try to see yoga as first choice oralternative to physical activity for these patients, which may help in bettermanaging their diabetes, enhance their work related performance andinter-personal interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Type 2 diabetes 2 Age > 30 years 3 Willing to come for Yoga sessions/study visits in AIIMS as per module 4 On basis of HbA1c depending upon type of therapy a)≥ 7.5% to ≤ 9% if only on oral drugs ± basal insulin b)≥ 7.5% to ≤ 10 %, if on premix insulin for ≥ 6 months, and glycemic status has not been successfully optimized despite on regular follow up of recruiting clinic for atleast 6 months and 4 clinical visits c)≥ 7.5% to any degree of hyperglycemia, if on multiple dose insulin for ≥ 6 months and glycemic status has not been successfully optimized, despite on regular follow up of recruiting clinic for atleast 6 months and 4 clinical visits 5 Eligibility on basis of patient health questionnaire-9 (PHQ-9)Patients with mild to moderate depression (PHQ-9 score from 5-14) are eligible.
- •Details of PHQ-9 are given ahead.
排除标准
- •1 Terminal illness 2 Known case of cancer 3 Nephropathy with CKD stage 4 and 5 4 Severe Non proliferative diabetic retinopathy, proliferative diabetic retinopathy, or macular edema 5 Any cardiovascular event requiring hospitalization in last 6 months 6 Active diabetic foot ulcer 7 Hospitalization for more than 24 hours within one month or 2 such episodes in last 6 months 8 Any death of first degree relative in last 6 months 9 PHQ-9 score < 5 or > 14 10 Suicidal thoughts nearly everyday i.e score of 3 for question 9 of PHQ-9 questionnaire 11 Patients with dementia (Montreal cognitive assessment or MOCA score < 19.
结局指标
主要结局
To evaluate the effect of Yoga on depression in patients with T2DM
时间窗: At 4 months
次要结局
- To evaluate the effect of Yoga on cognitive functions in patients with T2DM(At 4 and 8 months)
- To evaluate the effect of Yoga on glycemic control in patients with T2DM(At 4 and 8 months)
- To evaluate the effect of Yoga on depression in patients with T2DM(At 8 months)
- To evaluate the effect of Yoga on anxiety in patients with T2DM(At 4 and 8 months)
- To evaluate the effect of Yoga on diabetes related distress in patients with T2DM(At 4 and 8 months)
- To evaluate the effect of Yoga on other cardiovascular risk factors like weight, body mass index, blood pressure and lipid profile(At 4 and 8 months)