Post-cardiac SurgeryNCT06317376
Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery
A study testing MICT with Aerobic exercise on treadmill and standard hospital protocol in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients. 2. To determine the effect of MICT on aerobic Capacity of CABG patients. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- MICT with Aerobic exercise on treadmill and standard hospital protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 18 Jan 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females post CABG patients with ages of 40 to 60 years postoperatively.
- The patient with Post Op-Day 5.
Who cannot join
- Patients who have a history of other Cardiac disorders that interfere with daily life before surgery and those having congenital cardiac anomalies, Tetralogy of Fallot.
- Musculoskeletal and neurological disorders.
- Age more than 60 and less than 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Group-based Cardiac Rehabilitation on Pulmonary Function and Aerobic Capacity of Patients With Coronary Artery Bypass Graft Surgery
- To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.
- To determine the effect of MICT on aerobic Capacity of CABG patients.
- Conditions
- Post-cardiac Surgery
- Being tested
- MICT with Aerobic exercise on treadmill, standard hospital protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICT with Aerobic exercise on treadmillOther
MICT 3 session per week with Aerobic exercise on treadmill for 30 minute with moderate intensity.
standard hospital protocolOther
standard hospital protocol
| Study group | Role | What they receive |
|---|---|---|
| experimental group (MICT) | Experimental | MICT 3 session per week with Aerobic exercise on treadmill for 30 minute with moderate intensity. Receives: Other: MICT with Aerobic exercise on treadmill |
| control group (standard protocol) | Other | Perform standard hospital protocol 2-3 session per week Receives: Other: standard hospital protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg rating of perceived exertion scale
This scale is used to measure the appearance of the body in the reacttowith the exertion according to the vital sign and symptoms like increased heart rate, respiratory rate, sweating and muscle tiredness. This scale is ranged from 6 to 20 ranking, in thesrankingsng 6 represents "no exertion at all" and twenty reported "maximal exertion during activity". If participants reporta as 12 to 14 score othe n Borg scale this indicate that exertion is at moderate level during exertion. This scale will be used to measure the level of fatigue over all activity of life
Measured: 4 weeks
6min walk test
6 min walk test is used to measure the functional status of the individuals. It will be done on both groups to measure the functional status.
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Sep 2023
- Primary completion15 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Razzaq, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317376
- Sponsor's protocol ID
- REC/014131 Maria Haseen
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2024
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group-based Cardiac Rehabilitation on Pulmonary Function and Aerobic Capacity of Patients With Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06317376
- Acronym / sponsor ID
- REC/014131 Maria Haseen
- Conditions
- Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 19 Mar 2024 (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 determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.
- To determine the effect of MICT on aerobic Capacity of CABG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group (MICT) | Experimental | Other: MICT with Aerobic exercise on treadmillMICT 3 session per week with Aerobic exercise on treadmill for 30 minute with moderate intensity. |
| control group (standard protocol) | Other | Other: standard hospital protocolPerform standard hospital protocol 2-3 session per week |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and females post CABG patients with ages of 40 to 60 years postoperatively.
- The patient with Post Op-Day 5.
Key exclusion criteria (3 listed)
- Patients who have a history of other Cardiac disorders that interfere with daily life before surgery and those having congenital cardiac anomalies, Tetralogy of Fallot.
- Musculoskeletal and neurological disorders.
- Age more than 60 and less than 40
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 |
|---|---|---|
| MICT with Aerobic exercise on treadmillMICT 3 session per week with Aerobic exercise on treadmill for 30 minute with moderate intensity. | Other | experimental group (MICT) |
| standard hospital protocolstandard hospital protocol | Other | control group (standard protocol) |
Primary outcome
Borg rating of perceived exertion scale
Time frame: 4 weeks
This scale is used to measure the appearance of the body in the reacttowith the exertion according to the vital sign and symptoms like increased heart rate, respiratory rate, sweating and muscle tiredness. This scale is ranged from 6 to 20 ranking, in thesrankingsng 6 represents "no exertion at all" and twenty reported "maximal exertion during activity". If participants reporta as 12 to 14 score othe n Borg scale this indicate that exertion is at moderate level during exertion. This scale will be used to measure the level of fatigue over all activity of life
6min walk test
Time frame: 4weeks
6 min walk test is used to measure the functional status of the individuals. It will be done on both groups to measure the functional status.
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 19 Mar 2024.
- 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.
Maria Razzaq, MS 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 MICT with Aerobic exercise on treadmill and standard hospital protocol in people with Post-cardiac Surgery, 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 2 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 19 Mar 2024. 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?
Borg rating of perceived exertion scale (time frame: 4 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 19 Mar 2024.