Myocardial RevascularizationNCT04790656
Interventional Effects on Myocardial Revascularization Post-surgical Patients
A study testing Conventional Therapy and Cycle ergometer combine with CPAP in people with Myocardial Revascularization, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Revascularization
- What is being tested?
- Conventional Therapy and Cycle ergometer combine with CPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2020to 20 Aug 2021
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who have undergone myocardial revascularization surgery
- An ejection fraction of greater than40%
- Post operative mechanical ventilation for <12hours
- No definite diagnosis of chronic obstructive pulmonary disease and asthma
Who cannot join
- With complications in post operative period (e.g., Artial fibrillation, prolonged mechanical ventilation)
- Hemodynamically unstable patients
- Intolerance to CPAP(continuous positive airway)mask
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi institute of cardiology
Rawalpindi, Punjab Province, 43600
About this study
Official title: Effects of Continuous Positive Airway Pressure (CPAP)and Physical Exercise on Cycle Ergometer in Myocardial Revascularization Post-surgical Patients
The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization
Read the detailed description
Physical exercise on a cycle ergometer combine with CPAP as an adjunct to the rehabilitation of hospitalized subjects who will undergo myocardial revascularization will be safe, decrease the length of stay in the ICU, and help maintain functional capacity
- Conditions
- Myocardial Revascularization
- Being tested
- Conventional Therapy, Cycle ergometer combine with CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TherapyOther
Subjects will randomly placed into intervention group and control group . In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.
Cycle ergometer combine with CPAPOther
Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days . The maximum exercise time for postoperative day 2 will be 20 min, and 30 min for the third and fourth postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy | Active comparator | The control program will consist of progressive exercises according to each postoperative day. Two daily sessions with an average duration of 25 min will be performed. In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP. Receives: Other: Conventional Therapy |
| Cycle ergometer combine with CPAP | Experimental | Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days Receives: Other: Cycle ergometer combine with CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg scale
The Modified Borg Dyspnoea Scale is most commonly used to assess symptoms of breathlessness. Despite being a subjective measure of exercise intensity, RPE scales provide valuable information when used correctly.
Measured: 4th day
6 min walk distance
The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Measured: 4th day
1 min sit to stand test
Vaidya et al reported that 1-minute STS test is a simple and sensitive test and appears to be a practical, reliable, valid, and responsive alternative for measuring exercise capacity, particularly where space and time are limited
Measured: 4th day
Digital Monovacumeter
The manovacuometer is a simple, quick and non-invasive test which measures the maximal respiratory pressures (MRS).Digital manovacuometer is a reliable and valid instrument for assessing maximum inspiratory pressure and maximum expiratory pressure in healthy subjects
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start14 Oct 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial RevascularizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, Phd*, Principal investigator, Riphah college of rehabilitation and allied health sciences - Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790656
- Sponsor's protocol ID
- REC/00874 Arjumand Bano
- Status last verified
- Sep 2021
- First submitted
- 6 Mar 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Positive Airway Pressure (CPAP)and Physical Exercise on Cycle Ergometer in Myocardial Revascularization Post-surgical Patients
- ClinicalTrials.gov ID
- NCT04790656
- Acronym / sponsor ID
- REC/00874 Arjumand Bano
- Conditions
- Myocardial Revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 10 Mar 2021 (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.
The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization
Detailed description
Physical exercise on a cycle ergometer combine with CPAP as an adjunct to the rehabilitation of hospitalized subjects who will undergo myocardial revascularization will be safe, decrease the length of stay in the ICU, and help maintain functional capacity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Other: Conventional TherapyThe control program will consist of progressive exercises according to each postoperative day. Two daily sessions with an average duration of 25 min will be performed. In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP. |
| Cycle ergometer combine with CPAP | Experimental | Other: Cycle ergometer combine with CPAPPhysical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who have undergone myocardial revascularization surgery
- An ejection fraction of greater than40%
- Post operative mechanical ventilation for <12hours
- No definite diagnosis of chronic obstructive pulmonary disease and asthma
Key exclusion criteria (3 listed)
- With complications in post operative period (e.g., Artial fibrillation, prolonged mechanical ventilation)
- Hemodynamically unstable patients
- Intolerance to CPAP(continuous positive airway)mask
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 |
|---|---|---|
| Conventional TherapySubjects will randomly placed into intervention group and control group . In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP. | Other | Conventional Therapy |
| Cycle ergometer combine with CPAPPhysical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days . The maximum exercise time for postoperative day 2 will be 20 min, and 30 min for the third and fourth postoperative days. | Other | Cycle ergometer combine with CPAP |
Primary outcome
Modified Borg scale
Time frame: 4th day
The Modified Borg Dyspnoea Scale is most commonly used to assess symptoms of breathlessness. Despite being a subjective measure of exercise intensity, RPE scales provide valuable information when used correctly.
6 min walk distance
Time frame: 4th day
The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
1 min sit to stand test
Time frame: 4th day
Vaidya et al reported that 1-minute STS test is a simple and sensitive test and appears to be a practical, reliable, valid, and responsive alternative for measuring exercise capacity, particularly where space and time are limited
Digital Monovacumeter
Time frame: 4th day
The manovacuometer is a simple, quick and non-invasive test which measures the maximal respiratory pressures (MRS).Digital manovacuometer is a reliable and valid instrument for assessing maximum inspiratory pressure and maximum expiratory pressure in healthy subjects
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 23 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Myocardial Revascularization
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
Not yet recruiting
The CORE Platform Trial
Coronary Revascularization, Coronary Artery Disease
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
Not yet recruiting
Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
Postoperative Atrial Fibrillation
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.
Anam Aftab, Phd* principal investigator
Riphah college of rehabilitation and allied health sciences - Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Therapy and Cycle ergometer combine with CPAP in people with Myocardial Revascularization, 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 4 inclusion and 3 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 23 Sep 2021. 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?
Modified Borg scale (time frame: 4th day). The study lists 4 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 23 Sep 2021.