Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
Primary Purpose
COVID-19, Post Intensive Care Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic Exercise Training
Home Plan
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Aerobic exercise, COVID-19 Survivors, Post Intensive Care Syndrome
Eligibility Criteria
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.
Sites / Locations
- Allama Iqbal International Hospital & Mega Medical Complex.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control group
Arm Description
Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks
Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05341648
First Posted
March 8, 2022
Last Updated
November 24, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05341648
Brief Title
Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
Official Title
Effects of Aerobic Exercise Program in Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Post Intensive Care Syndrome
Keywords
Aerobic exercise, COVID-19 Survivors, Post Intensive Care Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Home Plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression
Description
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)
Time Frame
6 weeks
Title
6 min walk test: Distance (meters)
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allama Iqbal International Hospital & Mega Medical Complex.
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
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