SternotomyNCT06476756
Combined Effects of Active Cycle Breathing Technique and Buteyko Technique in Post Sternotomy Patients
A study testing ACTIVE CYCLE OF BREATHING TECHNIQUE and Buteyko techniques in people with Sternotomy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Sternotomy
- What is being tested?
- ACTIVE CYCLE OF BREATHING TECHNIQUE and Buteyko techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2024to 20 Aug 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 40-60 years
- Patient underwent cardiac surgery for first time
- Having speaking, hearing, cognitive ability
- Both genders ( Male and female)
- On mechanical ventilation for less than 24h after surgery
Who cannot join
- • Hemodynamic ally unstable patients
- Patients with reopening of sternum
- Infection patients
- Renal failure
- Arrhythmia
- Patient on mechanical ventilator
- Cancer
- Tuberculosis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi teaching hospital
Lahore, Punjab Province, 54000
Sidra Faisal, MS.CPPT, 03022001847, sidra.faisal@riphah.edu.pk
About this study
Official title: Combined Effects of Active Cycle Breathing Technique and Buteyko Technique on Airway Clearance in Post Sternotomy Patients
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.
Read the detailed description
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques. The three-day trial, starting upon ICU/CCU admission, will measure primary and secondary outcomes before and after each session for both groups. Statistical analysis using SPSS version 25 will be employed post data collection.
- Conditions
- Sternotomy
- Being tested
- ACTIVE CYCLE OF BREATHING TECHNIQUE, Buteyko techniques
- Keywords
- Buteyko
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVE CYCLE OF BREATHING TECHNIQUEOther
Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1.
Buteyko techniquesOther
Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE CYCLE OF BREATHING TECHNIQUE | Experimental | Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1. Receives: Other: ACTIVE CYCLE OF BREATHING TECHNIQUE |
| Buteyko techniques | Experimental | Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1. Receives: Other: Buteyko techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg dyspnea scale
The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.
Measured: base line and 4 week
BREATHLESSNESS, COUGH AND SPUTUM SCALE (BCSS)
The BCSS is a three-item patient-reported questionnaire that rates sputum, cough, and dyspnea . This instrument can identify a disease aggravation with sensitivity and specificity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start10 Mar 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SternotomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1. Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476756
- Sponsor's protocol ID
- REC/RCR & AHS/23/0375
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cappello IA, Candelari M, Pannone L, Monaco C, Bori E, Talevi G, Ramak R, La Meir M, Gharaviri A, Chierchia GB, Innocenti B, de Asmundis C. 3D Printed Surgical Guide for Coronary Artery Bypass Graft: Workflow from Computed Tomography to Prototype. Bioengineering (Basel). 2022 Apr 19;9(5):179. doi: 10.3390/bioengineering9050179.
PubMed 35621457Frak W, Wojtasinska A, Lisinska W, Mlynarska E, Franczyk B, Rysz J. Pathophysiology of Cardiovascular Diseases: New Insights into Molecular Mechanisms of Atherosclerosis, Arterial Hypertension, and Coronary Artery Disease. Biomedicines. 2022 Aug 10;10(8):1938. doi: 10.3390/biomedicines10081938.
PubMed 36009488Kamiya K, Takei M, Nagai T, Miyoshi T, Ito H, Fukumoto Y, Obara H, Kakuma T, Sakuma I, Daida H, Iimuro S, Shimokawa H, Kimura T, Nagai R, Anzai T. Association between Non-Lipid Residual Risk Factors and Cardiovascular Events in Patients with Stable Coronary Artery Disease Treated with Pitavastatin: An Observation from the REAL-CAD Study. J Atheroscler Thromb. 2024 Jan 1;31(1):61-80. doi: 10.5551/jat.64304. Epub 2023 Aug 11.
PubMed 37574272
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Active Cycle Breathing Technique and Buteyko Technique on Airway Clearance in Post Sternotomy Patients
- ClinicalTrials.gov ID
- NCT06476756
- Acronym / sponsor ID
- REC/RCR & AHS/23/0375
- Conditions
- Sternotomy
- Keywords
- Buteyko
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 26 Jun 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.
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.
Detailed description
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques. The three-day trial, starting upon ICU/CCU admission, will measure primary and secondary outcomes before and after each session for both groups. Statistical analysis using SPSS version 25 will be employed post data collection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1. Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.
| Arm | Type | Receives |
|---|---|---|
| ACTIVE CYCLE OF BREATHING TECHNIQUE | Experimental | Other: ACTIVE CYCLE OF BREATHING TECHNIQUEGroup A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1. |
| Buteyko techniques | Experimental | Other: Buteyko techniquesGroup B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 40-60 years
- Patient underwent cardiac surgery for first time
- Having speaking, hearing, cognitive ability
- Both genders ( Male and female)
- On mechanical ventilation for less than 24h after surgery
Key exclusion criteria (8 listed)
- • Hemodynamic ally unstable patients
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 |
|---|---|---|
| ACTIVE CYCLE OF BREATHING TECHNIQUEGroup A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1. | Other | ACTIVE CYCLE OF BREATHING TECHNIQUE |
| Buteyko techniquesGroup B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1. | Other | Buteyko techniques |
Primary outcome
Borg dyspnea scale
Time frame: base line and 4 week
The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.
BREATHLESSNESS, COUGH AND SPUTUM SCALE (BCSS)
Time frame: 4 weeks
The BCSS is a three-item patient-reported questionnaire that rates sputum, cough, and dyspnea . This instrument can identify a disease aggravation with sensitivity and specificity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 35621457Cappello IA, Candelari M, Pannone L, Monaco C, Bori E, Talevi G, Ramak R, La Meir M, Gharaviri A, Chierchia GB, Innocenti B, de Asmundis C. 3D Printed Surgical Guide for Coronary Artery Bypass Graft: Workflow from Computed Tomography to Prototype. Bioengineering (Basel). 2022 Apr 19;9(5):179. doi: 10.3390/bioengineering9050179.
- Background: PubMed 36009488Frak W, Wojtasinska A, Lisinska W, Mlynarska E, Franczyk B, Rysz J. Pathophysiology of Cardiovascular Diseases: New Insights into Molecular Mechanisms of Atherosclerosis, Arterial Hypertension, and Coronary Artery Disease. Biomedicines. 2022 Aug 10;10(8):1938. doi: 10.3390/biomedicines10081938.
- Background: PubMed 37574272Kamiya K, Takei M, Nagai T, Miyoshi T, Ito H, Fukumoto Y, Obara H, Kakuma T, Sakuma I, Daida H, Iimuro S, Shimokawa H, Kimura T, Nagai R, Anzai T. Association between Non-Lipid Residual Risk Factors and Cardiovascular Events in Patients with Stable Coronary Artery Disease Treated with Pitavastatin: An Observation from the REAL-CAD Study. J Atheroscler Thromb. 2024 Jan 1;31(1):61-80. doi: 10.5551/jat.64304. Epub 2023 Aug 11.
- 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.
Sidra Faisal, PP-DPT 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 ACTIVE CYCLE OF BREATHING TECHNIQUE and Buteyko techniques in people with Sternotomy, 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iqbal Tariq, PHD (O3338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg dyspnea scale (time frame: base line and 4 week). 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 NCT06476756, which also lists 3 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 26 Jun 2024.