Covid19NCT04445376
Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.
A study testing Physical Exercises in people with Covid19, run by Government College University Faisalabad at 1 site in Pakistan.
Trial summary
In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Physical Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jul 2020to 3 Oct 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recovered from COVID 19 disease (PCR report).
- Sub-normal performance as compared to normative data.
- Do not have any Respiratory Problem.
- Consent to participate in the study.
- Able to understand and perform the exercise.
- Age from 18 to 75.
- Dyspnea due to COVID19.
- Modified Borg Dyspnea Scale score at least 2 but less than 7.
Who cannot join
- Not suffered from COVID 19.
- Respiratory Problem.
- Resting Blood Pressure greater than 160/100 instead of taking medicine
- Greater than 1-month post COVID19 Recovery.
- Cardiorespiratory comorbidities which limit participation in exercise.
- Any Musculoskeletal problem which limit participation in Training.
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- Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2mm, symptomatic aortic stenosis, complex arrhythmias).
- Unstable angina
- Orthostatic blood pressure decrease of >20 mmHg with symptoms
- Hypertropic cardiomyopathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bin Inam Rehabilitation Center.
Faisalābad, Punjab Province, 38000
About this study
Official title: Effect of Aerobic Exercises on Cardio-respiratory Fitness and Quality of Life in Recovered COVID 19 Recovered Patients.
In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients to measure the improvement.
Read the detailed description
In December 2019, the first reports emerged of a novel severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) in Wuhan, China. The virus, which causes atypical pneumonia progressing to acute lung injury and acute respiratory distress syndrome (ARDS) in some individuals, was named COVID-19. The burden of fibrotic lung disease following SARS-CoV-2 infection is likely to be high; therefore, given the scale of the pandemic, the global burden of fibrotic lung disease will probably increase considerably. The aim of this study is to check the cardiorespiratory fitness level and the effect of Physical therapy intervention to improve the Cardiorespiratory fitness level in patients recovered from COVID-19. Quality of life has also been affected due to COVID19 due to decreased Cardiorespiratory fitness level, and this study also aims to improve the quality of life of people recovered from COVID19.
- Conditions
- Covid19
- Being tested
- Physical Exercises
- Keywords
- Cardiorespiratory fitness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExercisesOther
Aerobic Training and Breathing Exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Ventilatory) | Experimental | Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week. Receives: Other: Physical Exercises |
| Intervention (Non ventilatory) | Experimental | Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week. Receives: Other: Physical Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
To measure the cardio-respiratory fitness.
Measured: 5 weeks
Modified Borg Dyspnea Scale
It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
Measured: 5 weeks
Secondary outcomes (1)
SF-36 QUESTIONNAIRE
The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start3 Jul 2020
- Primary completion10 Sep 2020
- Study completion3 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishtiaq Ahmed, Government College University Faisalabad
- Investigators
- Ishtiaq Ahmed, DPT, Principal investigator, Government College University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445376
- Sponsor's protocol ID
- 313
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
PubMed 32422178Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
PubMed 32764112
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercises on Cardio-respiratory Fitness and Quality of Life in Recovered COVID 19 Recovered Patients.
- ClinicalTrials.gov ID
- NCT04445376
- Acronym / sponsor ID
- 313
- Conditions
- Covid19
- Keywords
- Cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 3 Oct 2020 (actual)
- First posted
- 24 Jun 2020 (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.
In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients to measure the improvement.
Detailed description
In December 2019, the first reports emerged of a novel severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) in Wuhan, China. The virus, which causes atypical pneumonia progressing to acute lung injury and acute respiratory distress syndrome (ARDS) in some individuals, was named COVID-19. The burden of fibrotic lung disease following SARS-CoV-2 infection is likely to be high; therefore, given the scale of the pandemic, the global burden of fibrotic lung disease will probably increase considerably. The aim of this study is to check the cardiorespiratory fitness level and the effect of Physical therapy intervention to improve the Cardiorespiratory fitness level in patients recovered from COVID-19. Quality of life has also been affected due to COVID19 due to decreased Cardiorespiratory fitness level, and this study also aims to improve the quality of life of people recovered from COVID19.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Ventilatory) | Experimental | Other: Physical ExercisesBreathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week. |
| Intervention (Non ventilatory) | Experimental | Other: Physical ExercisesBreathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Recovered from COVID 19 disease (PCR report).
- Sub-normal performance as compared to normative data.
- Do not have any Respiratory Problem.
- Consent to participate in the study.
- Able to understand and perform the exercise.
Key exclusion criteria (10 listed)
- Not suffered from COVID 19.
- Respiratory Problem.
- Resting Blood Pressure greater than 160/100 instead of taking medicine
- Greater than 1-month post COVID19 Recovery.
- Cardiorespiratory comorbidities which limit participation in exercise.
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 |
|---|---|---|
| Physical ExercisesAerobic Training and Breathing Exercises. | Other | Intervention (Non ventilatory), Intervention Group (Ventilatory) |
Primary outcome
6 minute walk test
Time frame: 5 weeks
To measure the cardio-respiratory fitness.
Modified Borg Dyspnea Scale
Time frame: 5 weeks
It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
1 secondary outcome
SF-36 QUESTIONNAIRE
Time frame: 5 weeks
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 8 Oct 2020.
- Background: PubMed 32422178George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
- Background: PubMed 32764112Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
- 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.
Ishtiaq Ahmed, DPT principal investigator
Government College 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 Physical Exercises in people with Covid19, run by Government College University Faisalabad 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 8 inclusion and 10 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 8 Oct 2020. 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. 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?
6 minute walk test (time frame: 5 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?
On the ClinicalTrials.gov record for NCT04445376, which also lists 2 linked publications.
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 8 Oct 2020.