COVID-19NCT05341648
Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
A study testing Aerobic Exercise Training and Home Plan in people with COVID-19 and Post Intensive Care Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- COVID-19, Post Intensive Care Syndrome
- What is being tested?
- Aerobic Exercise Training and Home Plan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal International Hospital & Mega Medical Complex.
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Aerobic Exercise Program in Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
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).
Read the 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.
- Conditions
- COVID-19, Post Intensive Care Syndrome
- Being tested
- Aerobic Exercise Training, Home Plan
- Keywords
- Aerobic exercise, COVID-19 Survivors, Post Intensive Care Syndrome
- Medical subject headings
- COVID-19, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
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
Home PlanOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks Receives: Other: Aerobic Exercise Training |
| Control group | Placebo comparator | Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks Receives: Other: Home Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start30 Apr 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341648
- Sponsor's protocol ID
- Rec/01089 Saad Tariq
- Status last verified
- Nov 2022
- First submitted
- 8 Mar 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Program in Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
- ClinicalTrials.gov ID
- NCT05341648
- Acronym / sponsor ID
- Rec/01089 Saad Tariq
- Conditions
- COVID-19, Post Intensive Care Syndrome
- Keywords
- Aerobic exercise, COVID-19 Survivors, Post Intensive Care Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Aerobic Exercise TrainingAerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks |
| Control group | Placebo comparator | Other: Home PlanHome plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingWarm-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 | Other | Experimental Group |
| 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. | Other | Control group |
Primary outcome
Hospital Anxiety and Depression
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehwish Waseem, MSPT(CPPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training and Home Plan in people with COVID-19 and Post Intensive Care Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.