Coronary Artery Bypass GraftNCT05058222
Effect of Deep Breathing Exercises on Post Operative Sleep Duration
A study testing Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise and Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise in people with Coronary Artery Bypass Graft, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Coronary Artery Bypass Graft
- What is being tested?
- Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise and Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2020to 30 Dec 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to read and write
- Stabilization of vital signs [blood pressure, pulse, respiration)
- Patient undergoing OFF Pump Coronary Artery Bypass Graft (CABG) Procedure
Who cannot join
- History of severe mental diseases resulting in hospitalization and drug treatment within the previous 6 months
- Use any kind of other complementary methods such as massage therapy, aromatherapy, etc. to treat sleep disorders for the previous two weeks
- History of sleep or respiration disorders and used CNS medications in the night.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed forces Institute of Cardiology
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effect of Deep Breathing Exercises on Post Operative Sleep Duration and Quality in Patients Undergoing CABG (Coronary Artery Bypass Graft).
This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality. This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality.
Read the detailed description
Subjects will be randomly placed into Control group and Interventional group. The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises. 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 additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days). Deep breathing exercises will start 48 hours after extubation and full education along with the routine care (i.e.: from the fourth to sixth postoperative day).
- Conditions
- Coronary Artery Bypass Graft
- Being tested
- Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise, Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise
- Keywords
- Breathing exercises, Coronary artery bypass, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths ExerciseOther
- The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.
Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths ExerciseOther
- The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).
| Study group | Role | What they receive |
|---|---|---|
| Deep breathing ex (10 reps) Group | Active comparator | The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises. Receives: Other: Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise |
| Deep breathing ex (30 reps) Group | Experimental | The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days). Receives: Other: Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
St Mary's Hospital Sleep Questionnaire (SMHSQ)
To check the quality of sleep over the past 24 hours. This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.
Measured: Baseline
St Mary's Hospital Sleep Questionnaire (SMHSQ)
To check the quality of sleep over the past 24 hours. This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start15 Oct 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT05058222
- Sponsor's protocol ID
- REC/00875 Amna Iqbal
- Status last verified
- Jan 2022
- First submitted
- 6 Mar 2021
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Breathing Exercises on Post Operative Sleep Duration and Quality in Patients Undergoing CABG (Coronary Artery Bypass Graft).
- ClinicalTrials.gov ID
- NCT05058222
- Acronym / sponsor ID
- REC/00875 Amna Iqbal
- Conditions
- Coronary Artery Bypass Graft
- Keywords
- Breathing exercises, Coronary artery bypass, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Sep 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.
This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality. This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality.
Detailed description
Subjects will be randomly placed into Control group and Interventional group. The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises. 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 additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days). Deep breathing exercises will start 48 hours after extubation and full education along with the routine care (i.e.: from the fourth to sixth postoperative day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep breathing ex (10 reps) Group | Active comparator | Other: Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths ExerciseThe control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises. |
| Deep breathing ex (30 reps) Group | Experimental | Other: Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths ExerciseThe intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days). |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to read and write
- Stabilization of vital signs [blood pressure, pulse, respiration)
- Patient undergoing OFF Pump Coronary Artery Bypass Graft (CABG) Procedure
Key exclusion criteria (3 listed)
- History of severe mental diseases resulting in hospitalization and drug treatment within the previous 6 months
- Use any kind of other complementary methods such as massage therapy, aromatherapy, etc. to treat sleep disorders for the previous two weeks
- History of sleep or respiration disorders and used CNS medications in the night.
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 |
|---|---|---|
| Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise• The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises. | Other | Deep breathing ex (10 reps) Group |
| Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise• The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days). | Other | Deep breathing ex (30 reps) Group |
Primary outcome
St Mary's Hospital Sleep Questionnaire (SMHSQ)
Time frame: Baseline
To check the quality of sleep over the past 24 hours. This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.
St Mary's Hospital Sleep Questionnaire (SMHSQ)
Time frame: 3 week
To check the quality of sleep over the past 24 hours. This SMH tool was a 14 item multiple choice and short answer instrument which examined individuals' previous nights sleep.
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 11 Jan 2022.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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 Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise and Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise in people with Coronary Artery Bypass Graft, 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 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 11 Jan 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. 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?
St Mary's Hospital Sleep Questionnaire (SMHSQ) (time frame: Baseline). 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 11 Jan 2022.