Effect of Integrated Approach of Yoga Therapy in Interstitial Lung Disease: A Randomised Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
研究概览
简要总结
The current study will be a single-centre, randomized, assessor-blinded crossover clinical trial to evaluate the effect of an Integrated Approach to Yoga Therapy compared with walking with music in patients with stable interstitial lung disease. Participants will be randomly allocated to one of two parallel sequences. One sequence will receive yoga therapy for 12 weeks, followed by a 15-day washout period, and then walking with music for 12 weeks. The other sequence will receive walking with music first, followed by washout and then yoga therapy. Standard medical care will be continued throughout the study.
The primary outcome will be health-related quality of life assessed using validated respiratory and general health questionnaires. Secondary outcomes will include functional exercise capacity, pulmonary function, dyspnoea, fatigue, anxiety, and depression, sleep quality, breath-holding time, and duration of Bhramari pranayama.
Outcome assessments will be conducted at five timepoints, including two baseline assessments one week apart, post-first intervention, post-washout, and post-second intervention. This crossover design will allow each participant to act as their own control while minimizing inter individual variability and enabling evaluation of treatment time and carryover effects. The study will aim to generate clinical evidence for yoga as a structured non-pharmacological adjunct in the management of interstitial lung disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with stable chronic ILD, including IPF, CTD-ILD, HP, and Undifferentiated ILD, whose diagnosis was made through a multi-disciplinary team discussion.
- •Consent to participate in a 26-week program.
- •An ambulatory patient capable of performing yoga.
排除标准
- •Forced Vital Capacity less than 50 percent Continuous Oxygen therapy b.
- •Diagnosis of pulmonary hypertension c.
- •Other respiratory diseases apart from ILD d.
- •Rapidly Progressive (RP-ILD) or unstable disease e.
- •Diagnosis of Cardio-respiratory failure, advanced malignancy, renal or hepatic failure, neurological diseases such as Parkinson’s, epilepsy and stroke.
- •Pulmonary infection, Acute exacerbation and other respiratory declines within the last 4 weeks g.
- •Recent abdominal surgery h.
- •Pregnant women i.
- •On anxiety/depression-related drugs j.
- •Patients admitted to the hospital (inpatients) k.
- •Patients who are currently on self-medication for ILD or any respiratory condition.
- •Patients who are receiving any form of alternative or complementary therapy, including but not limited to Ayurveda, Unani, Homoeopathy, Naturopathy, Siddha, Tibetan medicine, or other traditional/folk therapies.
- •Co-morbidities which make yoga training impossible n.
- •Who are regular yoga practitioners and engaged in systematic physical activities and mindfulness practice.
研究者
Prakriti Bohra
Swami Vivekananda Yoga Anusandhana Samsthana