Effect of Yoga-based Rehabilitation on pulmonary function in COVID-19 survivors with respiratory sequelae: A PROBE trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Pulmonary Function: Diffusion lung capacity for carbon monoxide (DLCO), Forced Vital capacity (FVC), Forced expiratory volume in first second (FEV1), Total lung capacity (TLC) using Pulmonary function test
Study Overview
Brief Summary
Coronavirus disease recovered cases reveal the varying degrees of radiological abnormalities associated with the deterioration of the pulmonary function which could manifest in a cascade of cardiopulmonary consequences and abnormal lung function. Also, unprecedented change, fear, and uncertainty during the COVID era has implicated in emotional distress, psychosocial dysfunction, and a surge of mental health problems. Yoga improvement in pulmonary function, rehabilitation, Health-Related Quality of Life and reduces Anxiety & Depression, several types of research have demonstrated the benefits of yoga. The current study attempts to explore yoga-based rehabilitation using a validated and customized yoga module. Keeping this in consideration, a randomized controlled open-label, endpoint blind, a clinical trial is planned to evaluate Yoga therapy as an add-on to standard care in Post covid patients.The proposed study design is a prospective randomized open label blinded endpoint trial with 1:1 allocation ratio. The study participant may fall into the intervention arm will give Yoga for 30 mint for 12 weeks.outcome measures on Baseline, after 6 weeks and at the end of 12 weeks of study.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a)Known case of COVID patients with respiratory symptoms on screening (RT-PCR negative or 4 weeks to 8 weeks from the onset of first symptom) b)Patients with forced vital capacity(FVC)<80% c)Patients of both sex and age of18-75years d)Patients who are able and willing to practice any form of exercise when recruited under the study e)Patients who are not engaged in regular and structured yoga practice.
Exclusion Criteria
- •a)Patients with forced vital capacity FVC<40 % b)Previous pulmonary complications like severe asthma, COPD, bronchiectasis, interstitial lung disease(IL) c)Known cases of CAD with moderate to severe LV dysfunction, patients with a history of CV or neurodegenerative diseases.
- •d)Lactating and pregnant women.
- •e)Patients currently participating in any other clinical trials with intervention.
Outcomes
Primary Outcomes
Pulmonary Function: Diffusion lung capacity for carbon monoxide (DLCO), Forced Vital capacity (FVC), Forced expiratory volume in first second (FEV1), Total lung capacity (TLC) using Pulmonary function test
Time Frame: Baseline, after 6 weeks and at the end of 12 weeks
Secondary Outcomes
- Severity of dyspnea using UCSD Shortness of Breath Questionnaire.(Exercise capacity using 6-minute walk test)