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

Not Applicable

Completed

• Conditions: COVID-19; Post Intensive Care Syndrome
• Interventions: Other: Home Plan; Other: Aerobic Exercise Training

• Registration Number: NCT05341648
• Lead Sponsor: Riphah International University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Study Start: 2022-04-30
• Status Verified: 2022-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Home Plan	Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks
Experimental Group	Aerobic Exercise Training	Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks

Primary Outcome Measures

Name	Time	Method
6 min walk test: Distance (meters)	6 weeks	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.
Hospital Anxiety and Depression	6 weeks	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)

Trial Locations

Locations (1)

Allama Iqbal International Hospital & Mega Medical Complex.; 🇵🇰 Rawalpindi, Punjab, Pakistan