Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)

Study Overview
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Brief Summary
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To investigate the effects of aerobic exercise program on physical activity, aerobic capacity, anxiety& depression in Covid-19 survivors discharged from Intensive Care Unit. There is evidence in the literature that post-intensive case survivors who have been mechanically ventilated will likely experience short- and medium-term consequences in the form of Post Intensive Care Syndrome (PICS).

Detailed Description
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The notion that patients surviving intensive care and mechanical ventilation for several weeks can be discharged home without further medical attention is a dangerous illusion. Post-Intensive Care Syndrome and other severe conditions will require not only adequate screening but early rehabilitation and other interventions. So, this focused control trial will contribute particularly to determining the Effects of the Aerobic Exercise Program in Covid-19 Survivors with Post-Intensive Care Syndrome.

Official Title
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Effects of Aerobic Exercise Program in Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)

Conditions
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COVID-19, Post Intensive Care Syndrome

Intervention / Treatment
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* Other: Aerobic Exercise Training
* Other: Home Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergo mechanical ventilation in the ICU. Recovered from Covid-19 & Discharged from ICU within the past 2 months. Hospital Anxiety and Depression Scale (HADS)>8. Scale≥ 2 on MRC Dyspnoea Scale. Subjects consenting to participate in the study. Exclusion Criteria: Positive Covid-19 Test. COPD and other respiratory diseases. Pre-existing psychotic dementia-type illness. Acute neurologic diseases (meningitis, ischemic hemorrhagic stroke). Patients with chronic systemic disease.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks | Other: Aerobic Exercise Training<br>* Warm-up: 5 minutes Aerobic Training Treadmill/cycle ergometer Frequency:3 days a week Intensity:40-70% of HR max(Start from 40% than increment to as per patient tolerance) Total Duration:6 weeks. Duration of each session:15-30 mins. Cool-down: 5 minutes<br>|
| Placebo Comparator: Control group<br>Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks | Other: Home Plan<br>* Positions to ease breathlessness Controlled breathing/Deep breathing*10 Reps* TD,s Progressive Muscle Relaxation Exercises. ROM & Flexibility Exercises. 3 days a week for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression | Changes from baseline till 6 weeks, Assessed through Hospital Anxiety and Depression Scale (HADS): Questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Scoring is as followed: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) | 6 weeks | 
| 6 min walk test: Distance (meters) | Changes from the baseline till the 6th week, 6 min walk test (6 MWT) was used to measure Functional capacity. It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic exercise, COVID-19 Survivors, Post Intensive Care Syndrome