Respiratory RehabilitationNCT05736770
Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients
A study testing Respiratory rehabilitation and out of bed mobilization and conventional treatment in people with Respiratory Rehabilitation, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of conventional preoperative respiratory rehabilitation and specific preoperative respiratory rehabilitation program on pulmonary functions in coronary artery bypass graft patients. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Respiratory Rehabilitation
- What is being tested?
- Respiratory rehabilitation and out of bed mobilization and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 21 Aug 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective Coronary Artery Bypass Grafting (CABG) surgery for Triple vessel coronary artery disease (TVCAD), double vessel coronary artery disease (DVCAD), single vessel coronary artery disease (SVCAD) and left main stem (LMS) disease.
- Patients who cover at least 400 steps on 6-minute walk test.
- Patients with ejection fraction 45% or more
Who cannot join
- Acute ailments i.e., patient's cardiac condition deteriorating.
- Cardiac emergency (shock, acute MI)
- Presence of neurological disorders e.g., altered state of consciousness, paralysis.
- Redo surgeries
- Any musculoskeletal disorder e.g., amputation of limb, problems of balance and risks of fall, muscles weakness grade 3 or less, osteoporosis; leading to limitation in exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-operative Respiratory Rehabilitation on Post- Operative Outcomes in Coronary Artery Bypass Graft Patients
To compare the effects of conventional preoperative respiratory rehabilitation and specific preoperative respiratory rehabilitation program on pulmonary functions in coronary artery bypass graft patients.
Read the detailed description
After cardiac surgeries many postoperative changes occur that lead to pulmonary complication such as respiratory changes, functional capacity of lungs and gaseous changes that leads to hypoxemia and ischemic injury of lungs. CABG, although a successful procedure, post operative pulmonary complications still pursue a big challenge to the health and fitness of the patients. Although post operative complications have been managed in in-patient setup post CABG, there are pre-operative measures on the rise to prevent the complications to occur after CABG.
This study will contribute in describing the rate of improvement in pulmonary functions with rehabilitation program including preoperative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume-based incentive spirometry as compared to the conventional treatment of flow-based incentive spirometry and chest percussion in prevention of post operative pulmonary complications occurring after CABG leading to delayed recovery of patients.
- Conditions
- Respiratory Rehabilitation
- Being tested
- Respiratory rehabilitation and out of bed mobilization, conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rehabilitation and out of bed mobilizationOther
The Respiratory rehabilitation and out of bed mobilization group will perform following exercises: pre operative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume based incentive spirometery
conventional treatmentOther
The conventional exercise program group will perform :Flow based Incentive spirometery, Chest percussion if needed
| Study group | Role | What they receive |
|---|---|---|
| Respiratory rehabilitation and out of bed mobilization group | Experimental | The Respiratory rehabilitation and out of bed mobilization group will perform 4 exercises. Receives: Other: Respiratory rehabilitation and out of bed mobilization |
| Conventional exercise program group | Active comparator | The conventional exercises program will perform conventional exercises Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The normal test values range between 80% and 120% of the average (predicted) values.
Measured: 4th postoperative day of coronary artery bypass graft (CABG)
Forced Vital Capacity (FVC)
Forced Vital Capacity measures the total volume of air that you were able to blow forcefully into the mouthpiece following a full inhalation
Measured: 4th postoperative day of coronary artery bypass graft (CABG)
Ratio of Forced expiratory volume in 1 second and Forced Vital Capacity (FEV1/FVC)
FEV1/FVC: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value. In healthy adults of the same gender, height, and age, the normal Predicted percentage should be between 70% and 85.
Measured: 4th postoperative day of coronary artery bypass graft (CABG)
Secondary outcomes (2)
6-minute walk test (6MWT)
six minutes walk test (6MWT) is test used to measure functional exercise capacity of patients with cardiovascular and/or pulmonary disease. In this test, patient performs walk for 6 minutes while time being counted on stopwatch. The patient can take rest between the walk, but the timer keeps on running and the rest period is counted. At the end of the test, patient's level of exertion is noted, and the distance measured is recorded. The 6MWT distance values for a healthy person are 400-700m.
Measured: 4th postoperative day of coronary artery bypass graft (CABG)
Borg scale
The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness and fatigue during physical work. Patients are asked to tell the whole feeling of exertion including leg pain and shortness of breath and it is marked on a number from 6-20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion".
Measured: 4th postoperative day of coronary artery bypass graft (CABG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Mar 2023
- Primary completion10 Jun 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory RehabilitationStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Ali Awan, MS-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736770
- Sponsor's protocol ID
- Riphah/RCRS/REC/ 01378
- Status last verified
- Aug 2023
- First submitted
- 13 Jan 2023
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Respiratory Rehabilitation on Post- Operative Outcomes in Coronary Artery Bypass Graft Patients
- ClinicalTrials.gov ID
- NCT05736770
- Acronym / sponsor ID
- Riphah/RCRS/REC/ 01378
- Conditions
- Respiratory Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 21 Feb 2023 (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 compare the effects of conventional preoperative respiratory rehabilitation and specific preoperative respiratory rehabilitation program on pulmonary functions in coronary artery bypass graft patients.
Detailed description
After cardiac surgeries many postoperative changes occur that lead to pulmonary complication such as respiratory changes, functional capacity of lungs and gaseous changes that leads to hypoxemia and ischemic injury of lungs. CABG, although a successful procedure, post operative pulmonary complications still pursue a big challenge to the health and fitness of the patients. Although post operative complications have been managed in in-patient setup post CABG, there are pre-operative measures on the rise to prevent the complications to occur after CABG.
This study will contribute in describing the rate of improvement in pulmonary functions with rehabilitation program including preoperative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume-based incentive spirometry as compared to the conventional treatment of flow-based incentive spirometry and chest percussion in prevention of post operative pulmonary complications occurring after CABG leading to delayed recovery of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory rehabilitation and out of bed mobilization group | Experimental | Other: Respiratory rehabilitation and out of bed mobilizationThe Respiratory rehabilitation and out of bed mobilization group will perform 4 exercises. |
| Conventional exercise program group | Active comparator | Other: conventional treatmentThe conventional exercises program will perform conventional exercises |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective Coronary Artery Bypass Grafting (CABG) surgery for Triple vessel coronary artery disease (TVCAD), double vessel coronary artery disease (DVCAD), single vessel coronary artery disease (SVCAD) and left main stem (LMS) disease.
- Patients who cover at least 400 steps on 6-minute walk test.
- Patients with ejection fraction 45% or more
Key exclusion criteria (5 listed)
- Acute ailments i.e., patient's cardiac condition deteriorating.
- Cardiac emergency (shock, acute MI)
- Presence of neurological disorders e.g., altered state of consciousness, paralysis.
- Redo surgeries
- Any musculoskeletal disorder e.g., amputation of limb, problems of balance and risks of fall, muscles weakness grade 3 or less, osteoporosis; leading to limitation 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 |
|---|---|---|
| Respiratory rehabilitation and out of bed mobilizationThe Respiratory rehabilitation and out of bed mobilization group will perform following exercises: pre operative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume based incentive spirometery | Other | Respiratory rehabilitation and out of bed mobilization group |
| conventional treatmentThe conventional exercise program group will perform :Flow based Incentive spirometery, Chest percussion if needed | Other | Conventional exercise program group |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 4th postoperative day of coronary artery bypass graft (CABG)
The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The normal test values range between 80% and 120% of the average (predicted) values.
Forced Vital Capacity (FVC)
Time frame: 4th postoperative day of coronary artery bypass graft (CABG)
Forced Vital Capacity measures the total volume of air that you were able to blow forcefully into the mouthpiece following a full inhalation
Ratio of Forced expiratory volume in 1 second and Forced Vital Capacity (FEV1/FVC)
Time frame: 4th postoperative day of coronary artery bypass graft (CABG)
FEV1/FVC: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value. In healthy adults of the same gender, height, and age, the normal Predicted percentage should be between 70% and 85.
2 secondary outcomes
6-minute walk test (6MWT)
Time frame: 4th postoperative day of coronary artery bypass graft (CABG)
Borg scale
Time frame: 4th postoperative day of coronary artery bypass graft (CABG)
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 1 Sep 2023.
- 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.
Muhammad Ali Awan, MS-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 Respiratory rehabilitation and out of bed mobilization and conventional treatment in people with Respiratory Rehabilitation, 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 3 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 1 Sep 2023. 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?
Forced expiratory volume in one second (FEV1) (time frame: 4th postoperative day of coronary artery bypass graft (CABG)). The study lists 3 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 1 Sep 2023.