The Effect of Exercise based Rehabilitation for recovery after post-acute COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- The primary outcome measures of 6 Minute Walk Test (6MWT), Chest expansion measurement and 30 seconds Sit to Stand test(30STST) are used to assess the cardio-respiratory exercise endurance and functional status of the subjects
Study Overview
Brief Summary
**Background:**COVID-19 is a multi-system disease that causes impaired lung and physical function, reduced quality of life with emotional distress. It is observed that sequelae of symptoms such as fatigue, muscle weakness, sleep difficulties, anxiety and depression persisted for 6 to 9 months after infection in COVID-19 patients. The persistence of complications following COVID-19 may lead to substantial morbidity as there is no clear plan for the management of such patients.
Multiple symptoms persisting about 3 months after the onset of symptoms in COVID19 patients either in hospitalised or non-hospitalised patients suggested the presence of a “post-COVID-19 syndrome†implying a long term healthcare needs in patients with both “mild†and “severe†COVID-19.
Method:
Group A: Subjects randomised to 8 weeks of home- based exercise program supervised through tele-rehabilitation by using a smart phone/tablet which will be used to facilitate communication through video calls between the therapist and subjects and to share exercise protocol and educational material to the patient.
Group B: Subjects randomised to 8 weeks of home based unsupervised exercise program received through an exercise manual provided at the time of their baseline assessment. They will use the exercise manual to guide through the exercise program.
Outcome: After doing the baseline assessment of the subjects prior to intervention with exercise based rehabilitation in both groups a staggered follow-up of these groups will be done at 4 weeks, 8 weeks and 12 weeks using the following primary outcome measures of 6 Minute Walk Test (6MWT), Chest expansion measurement and 30 seconds Sit to Stand Test (30STST) to assess the cardio-respiratory exercise endurance and functional status of the subjects. The secondary outcome measures of mMRC- dyspnea scale, Modified Borg Scale and SF-36 quality of life questionnaire will be used to assess the associated factors like dyspnea, rate of perceived exertion and quality of life
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Post Acute COVID-19 Subjects who are being able to ambulate without assistance or assistive devices and Subjects familiar with use of smart phones/tablets.
Exclusion Criteria
- •Resting Heart rate >120 beats/minute, Blood pressure <90/60 mmHg or >140/90 mmHg, Blood oxygen saturation <95%, Unstable Cardiovascular diseases/Pacemakers, Neuromuscular Disorders, Severe Lower limb impairment and Severe Cognitive Impairment.
Outcomes
Primary Outcomes
The primary outcome measures of 6 Minute Walk Test (6MWT), Chest expansion measurement and 30 seconds Sit to Stand test(30STST) are used to assess the cardio-respiratory exercise endurance and functional status of the subjects
Time Frame: All the parameters taken prior to intervention would be reassessed at 4 weeks, 8 weeks and 12 weeks of intervention
Secondary Outcomes
- The secondary outcome measures of mMRC-dyspnea scale, Modified Borg RPE Scale and SF- 36 quality of life questionnaire will be used to assess the associated factors like dyspnea, rate of perceived exertion and quality of life(All the parameters taken prior to intervention would be reassessed at 4weeks, 8weeks and 12 weeks of intervention)