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

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05341648

Collaborator

(none)

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Post Intensive Care Syndrome	Other: Aerobic Exercise Training Other: Home Plan	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 30, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks	Other: Aerobic Exercise Training 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
Placebo Comparator: Control group Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks	Other: Home Plan Positions to ease breathlessness Controlled breathing/Deep breathing10 Reps TD,s Progressive Muscle Relaxation Exercises. ROM & Flexibility Exercises. 3 days a week for 6 weeks.

Arm

Intervention/Treatment

Experimental: Experimental Group

Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks

Other: Aerobic Exercise Training

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

Placebo Comparator: Control group

Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks

Other: Home Plan

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.

Outcome Measures

Primary Outcome Measures

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)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allama Iqbal International Hospital & Mega Medical Complex.	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05341648

Other Study ID Numbers:

Rec/01089 Saad Tariq

First Posted:

Apr 22, 2022

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Aerobic exercise

COVID-19 Survivors

Post Intensive Care Syndrome

Additional relevant MeSH terms:

COVID-19

Syndrome

Study Results

No Results Posted as of Apr 22, 2022