Peak Expiratory Flow RateNCT07875049
Additional Effects of Flutter With Conventional Chest Physiotherapy on Peak Expiratory Flow Rate and Chest Expansion in Post CABG Patients With COPD
A study testing Conventional Chest Physiotherapy and Flutter device with conventional chest physiotherapy in people with Peak Expiratory Flow Rate and Coronary Artery Bypass Graft Surgery, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations to facilitate mobilization and clearance of respiratory secretions. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Conventional Chest Physiotherapy and Flutter device with conventional chest physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-70 years undergoing elective CABG
- Pre-existing COPD (mild- moderate), clinically diagnosed COPD
- Early post-operative (24-72 hrs.), extubated and hemodynamically stable
- No mechanical ventilation beyond 24 hrs., stable vitals (HR: 60-100bpm, SBP :110-130mmhg), no vasopressors.
- Follow commands, provide consent and perform assessments.
Who cannot join
- Patients undergoing emergency CABG or revision/repeat CABG procedure
- Patients with severe COPD or intersitial lung disease
- Contraindications positive expiratoey pressure (PEP) therapy (e.g, untreated pneumothorax, hemoptysis or recent esophageal surgery).
- Hemodynamically unstable patients post-operatively.
- Patients with neurological, musculoskeletal or cognitive impairments.
- Patients with active infections, malignancy.
- Patients with severe or uncontrolled comorbidities(e.g; renal failure).
- Patients in BiPAP.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Rawalpindi, 46000
Syeda Sumaira Batool, MS-CCPT, +923328868680, sumaira.batool@fui.edu.pk
About this study
Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations to facilitate mobilization and clearance of respiratory secretions. Conventional chest physiotherapy includes deep breathing exercises, incentive spirometry, airway-clearance techniques, splinted coughing and early mobilization to promote lung expansion and secretion clearance. A total of 94 patients aged 40-70 years with mild-to-moderate COPD undergoing elective coronary artery bypass grafting (CABG) will be enrolled in this randomized controlled trial and will be randomly allocated into two groups, with 47 participants in each group. The intervention group will receive conventional chest physiotherapy combined with Flutter therapy, while the control group will receive conventional chest physiotherapy alone. Both groups will receive supervised treatment for 5 consecutive postoperative days, with 3 sessions per day, resulting in 15 treatment sessions. Baseline assessment will be performed on postoperative day 1 before commencement of the intervention, and post-intervention assessment will be conducted on postoperative day 5. The study will compare the effects of Flutter-assisted conventional chest physiotherapy versus conventional chest physiotherapy alone on postoperative peak expiratory flow rate, chest expansion and airway clearance.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is associated with persistent respiratory symptoms, airflow limitation and increased mucus secretion and retention. Patients undergoing coronary artery bypass grafting (CABG) are also at risk of developing postoperative pulmonary complications. The co-existence of COPD may further affect the postoperative respiratory recovery and airway clearance. Conventional chest physiotherapy (CPT) is commonly used in the postoperative management of CABG patients to facilitate lung expansion, improve ventilation and promote Airway clearance. Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations and is used to facilitate mobilization and airway clearance. The present randomized controlled trial is designed to investigate the additional effects of Flutter therapy when combined with CPT in post-CABG patients with COPD. A total of 84 participants will be included in the study and randomly allocated into two groups. Group A will serve as the control group and will receive CPT alone. Group B will serve as the intervention group and will receive CPT in combination with Flutter therapy. Selection of subjects will be done by using non-probability purposive sampling technique. The sample size was calculated using G* power software version 3.1. Normality testing will be done by using Shapiro-Wilk Test. Based on the normality test, difference within groups will be determined using paired t-test (Wilcoxon Signed Rank) whereas difference between two groups will be determined using independent t-test (Mann Whitney U). Data will be analyzed using SPSS v. 21.0. The intervention will be administered for five consecutive days during the postoperative period. Three treatment sessions will be provided each day, resulting in a total of 15 treatment sessions for each participant. Participants in the control group will receive CPT according to the study protocol whereas in the intervention group will receive the same CPT program with the addition of Flutter therapy. The treatment procedures will be administered according to the predefined study protocol throughout the intervention period. The study assessments will be performed according to the specified assessment schedule. Assessment will be conducted before the intervention and after completion of the five-day treatment period. The outcome assessor will be blinded to the group allocation. This blinding will be maintained during assessment to minimize potential assessment bias between the control and intervention groups. The study will therefore provide a comparison between CPT alone and CPT with Flutter therapy in post-CABG patients with COPD. The comparison is intended to determine the additional effects associated with incorporating Flutter therapy into CPT during the postoperative treatment period. The study will focus on the changes observed following the specified treatment program and will provide evidence regarding the additional role of Flutter therapy as an adjunct to CPT in this patient population. All study procedures will be conducted in accordance with the predefined study protocol. Data generated during the study will be recorded systematically and analyzed according to the statistical procedures specified in the research protocol.
- Conditions
- Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery, Chronic Obstructive Pulmonary Disease
- Being tested
- Conventional Chest Physiotherapy, Flutter device with conventional chest physiotherapy
- Keywords
- Conventional Chest Physiotherapy, Chest Expansion, Flutter
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest PhysiotherapyProcedure or surgery
- Diaphragmatic Breathing Description: Slow deep breathing emphasizing diaphragmatic movement performed for10 repetitions × 3 sets per session.
- Incentive Spirometry Description: Sustained maximal inspiration using an incentive spirometer 10 repetitions × 3 sets per session.
- Chest Percussion Description: Rhythmic clapping of the chest wall with a cupped, 02-03 minutes on Day 1, 03-05 minutes on Days 2-5.
- Splinted Coughing Description: Controlled coughing with support to the surgical incision using a pillow or hands to facilitate secretion clearance while minimizing discomfort as needed/occasional during the session.
- Early Mobilization Description: Gradual progression of physical activity during the postoperative period, including sitting, standing and ambulation, as tolerated.
A 05-day protocol will be followed.
Flutter device with conventional chest physiotherapyDevice
Flutter therapy will be administered as an adjunct to conventional chest physiotherapy using a portable, oscillating positive expiratory pressure (OPEP) device, for 3 sessions per day for 5 consecutive postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Group A: conventional chest physiotherapy | Active comparator | Participants allocated to Group A (control group) will receive conventional chest physiotherapy during the early postoperative period following CABG. The intervention will comprise deep breathing exercises, incentive spirometry, airway-clearance techniques, splinted coughing and early mobilization. Treatment will be administered under supervision for 5 consecutive postoperative days, with 3 sessions per day, resulting in a total of 15 treatment sessions. The techniques will be performed according to the standardized study protocol and adapted to the participant's postoperative clinical status and tolerance Receives: Procedure: Conventional Chest Physiotherapy |
| Group B: Flutter therapy | Experimental | Participants allocated to Group B (intervention group) will receive conventional chest physiotherapy combined with Flutter therapy during the early postoperative period following CABG. Flutter therapy will be administered as an adjunct to conventional chest physiotherapy using an oscillating positive expiratory pressure (OPEP) device to facilitate airway secretion clearance. Treatment will be supervised for 5 consecutive postoperative days, with 3 sessions per day, resulting in a total of 15 sessions. The intervention will be adapted according to the participant's postoperative clinical status and tolerance. Receives: Device: Flutter device with conventional chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow Rate
Peak expiratory flow rate will be assessed using a peak flow meter. Three expiratory trials will be performed, and the highest recorded value will be documented in liters per minute (L/min).
Measured: 5 days
Chest Expansion
Measured using measuring tape at the axillary, mid thoracic/sternal, and xiphoid levels by recording chest circumference at inspiration and expiration.
Measured: 5 days
Secondary outcomes (3)
Total Expectorated Sputum Volume (mL)
Airway clearance will be assessed by measuring the total volume of expectorated sputum collected, recorded in milliliters (mL). Sputum volume will be recorded during the five-day assessment period.
Measured: 5 days
Dyspnea
Dyspnea will be assessed using the Modified Borg Scale to quantify the participant's perceived intensity of breathlessness. The participants will rate their perceived level of dyspnea using the scale at the specified assessment time points.
Measured: 5 days
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Respiratory symptom severity will be assessed using the Breathlessness, Cough and Sputum Scale (BCSS), a three-item questionnaire evaluating breathlessness, cough, and sputum symptoms. Each item is scored from 0 to 4, giving a total score ranging from 0 to 12. A score of 0 indicates no symptoms, whereas higher total scores indicate greater respiratory symptom severity and a worse outcome.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start11 Feb 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peak Expiratory Flow RateStudies 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
- Model description
- This is a randomized controlled trial having two groups. One group (control group) will receive conventional chest physiotherapy alone and the second group (intervention group) will receive conventional chest physiotherapy along with Flutter therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875049
- Sponsor's protocol ID
- KashafNadeemCPT/FUCP-27
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Flutter With Conventional Chest Physiotherapy on Peak Expiratory Flow Rate and Chest Expansion in Post CABG Patients With COPD
- ClinicalTrials.gov ID
- NCT07875049
- Acronym / sponsor ID
- KashafNadeemCPT/FUCP-27
- Conditions
- Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery, Chronic Obstructive Pulmonary Disease
- Keywords
- Conventional Chest Physiotherapy, Chest Expansion, Flutter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 15 Oct 2026 (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.
Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations to facilitate mobilization and clearance of respiratory secretions. Conventional chest physiotherapy includes deep breathing exercises, incentive spirometry, airway-clearance techniques, splinted coughing and early mobilization to promote lung expansion and secretion clearance. A total of 94 patients aged 40-70 years with mild-to-moderate COPD undergoing elective coronary artery bypass grafting (CABG) will be enrolled in this randomized controlled trial and will be randomly allocated into two groups, with 47 participants in each group. The intervention group will receive conventional chest physiotherapy combined with Flutter therapy, while the control group will receive conventional chest physiotherapy alone. Both groups will receive supervised treatment for 5 consecutive postoperative days, with 3 sessions per day, resulting in 15 treatment sessions. Baseline assessment will be performed on postoperative day 1 before commencement of the intervention, and post-intervention assessment will be conducted on postoperative day 5. The study will compare the effects of Flutter-assisted conventional chest physiotherapy versus conventional chest physiotherapy alone on postoperative peak expiratory flow rate, chest expansion and airway clearance.
Detailed description
Chronic obstructive pulmonary disease (COPD) is associated with persistent respiratory symptoms, airflow limitation and increased mucus secretion and retention. Patients undergoing coronary artery bypass grafting (CABG) are also at risk of developing postoperative pulmonary complications. The co-existence of COPD may further affect the postoperative respiratory recovery and airway clearance. Conventional chest physiotherapy (CPT) is commonly used in the postoperative management of CABG patients to facilitate lung expansion, improve ventilation and promote Airway clearance. Flutter therapy is an oscillating positive expiratory pressure (OPEP) technique that combines positive expiratory pressure with airway oscillations and is used to facilitate mobilization and airway clearance. The present randomized controlled trial is designed to investigate the additional effects of Flutter therapy when combined with CPT in post-CABG patients with COPD. A total of 84 participants will be included in the study and randomly allocated into two groups. Group A will serve as the control group and will receive CPT alone. Group B will serve as the intervention group and will receive CPT in combination with Flutter therapy. Selection of subjects will be done by using non-probability purposive sampling technique. The sample size was calculated using G* power software version 3.1. Normality testing will be done by using Shapiro-Wilk Test. Based on the normality test, difference within groups will be determined using paired t-test (Wilcoxon Signed Rank) whereas difference between two groups will be determined using independent t-test (Mann Whitney U). Data will be analyzed using SPSS v. 21.0. The intervention will be administered for five consecutive days during the postoperative period. Three treatment sessions will be provided each day, resulting in a total of 15 treatment sessions for each participant. Participants in the control group will receive CPT according to the study protocol whereas in the intervention group will receive the same CPT program with the addition of Flutter therapy. The treatment procedures will be administered according to the predefined study protocol throughout the intervention period. The study assessments will be performed according to the specified assessment schedule. Assessment will be conducted before the intervention and after completion of the five-day treatment period. The outcome assessor will be blinded to the group allocation. This blinding will be maintained during assessment to minimize potential assessment bias between the control and intervention groups. The study will therefore provide a comparison between CPT alone and CPT with Flutter therapy in post-CABG patients with COPD. The comparison is intended to determine the additional effects associated with incorporating Flutter therapy into CPT during the postoperative treatment period. The study will focus on the changes observed following the specified treatment program and will provide evidence regarding the additional role of Flutter therapy as an adjunct to CPT in this patient population. All study procedures will be conducted in accordance with the predefined study protocol. Data generated during the study will be recorded systematically and analyzed according to the statistical procedures specified in the research protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group (control group) will receive conventional chest physiotherapy alone and the second group (intervention group) will receive conventional chest physiotherapy along with Flutter therapy.
| Arm | Type | Receives |
|---|---|---|
| Group A: conventional chest physiotherapy | Active comparator | Procedure: Conventional Chest PhysiotherapyParticipants allocated to Group A (control group) will receive conventional chest physiotherapy during the early postoperative period following CABG. The intervention will comprise deep breathing exercises, incentive spirometry, airway-clearance techniques, splinted coughing and early mobilization. Treatment will be administered under supervision for 5 consecutive postoperative days, with 3 sessions per day, resulting in a total of 15 treatment sessions. The techniques will be performed according to the standardized study protocol and adapted to the participant's postoperative clinical status and tolerance |
| Group B: Flutter therapy | Experimental | Device: Flutter device with conventional chest physiotherapyParticipants allocated to Group B (intervention group) will receive conventional chest physiotherapy combined with Flutter therapy during the early postoperative period following CABG. Flutter therapy will be administered as an adjunct to conventional chest physiotherapy using an oscillating positive expiratory pressure (OPEP) device to facilitate airway secretion clearance. Treatment will be supervised for 5 consecutive postoperative days, with 3 sessions per day, resulting in a total of 15 sessions. The intervention will be adapted according to the participant's postoperative clinical status and tolerance. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40-70 years undergoing elective CABG
- Pre-existing COPD (mild- moderate), clinically diagnosed COPD
- Early post-operative (24-72 hrs.), extubated and hemodynamically stable
- No mechanical ventilation beyond 24 hrs., stable vitals (HR: 60-100bpm, SBP :110-130mmhg), no vasopressors.
- Follow commands, provide consent and perform assessments.
Key exclusion criteria (8 listed)
- Patients undergoing emergency CABG or revision/repeat CABG procedure
- Patients with severe COPD or intersitial lung disease
- Contraindications positive expiratoey pressure (PEP) therapy (e.g, untreated pneumothorax, hemoptysis or recent esophageal surgery).
- Hemodynamically unstable patients post-operatively.
- Patients with neurological, musculoskeletal or cognitive impairments.
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 Chest Physiotherapy1. Diaphragmatic Breathing Description: Slow deep breathing emphasizing diaphragmatic movement performed for10 repetitions × 3 sets per session. 2. Incentive Spirometry Description: Sustained maximal inspiration using an incentive spirometer 10 repetitions × 3 sets per session. 3. Chest Percussion Description: Rhythmic clapping of the chest wall with a cupped, 02-03 minutes on Day 1, 03-05 minutes on Days 2-5. 4. Splinted Coughing Description: Controlled coughing with support to the surgical incision using a pillow or hands to facilitate secretion clearance while minimizing discomfort as needed/occasional during the session. 5. Early Mobilization Description: Gradual progression of physical activity during the postoperative period, including sitting, standing and ambulation, as tolerated. A 05-day protocol will be followed. | Procedure or surgery | Group A: conventional chest physiotherapy |
| Flutter device with conventional chest physiotherapyFlutter therapy will be administered as an adjunct to conventional chest physiotherapy using a portable, oscillating positive expiratory pressure (OPEP) device, for 3 sessions per day for 5 consecutive postoperative days. | Device | Group B: Flutter therapy |
Primary outcome
Peak Expiratory Flow Rate
Time frame: 5 days
Peak expiratory flow rate will be assessed using a peak flow meter. Three expiratory trials will be performed, and the highest recorded value will be documented in liters per minute (L/min).
Chest Expansion
Time frame: 5 days
Measured using measuring tape at the axillary, mid thoracic/sternal, and xiphoid levels by recording chest circumference at inspiration and expiration.
3 secondary outcomes
Total Expectorated Sputum Volume (mL)
Time frame: 5 days
Dyspnea
Time frame: 5 days
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
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 Chest Physiotherapy and Flutter device with conventional chest physiotherapy in people with Peak Expiratory Flow Rate and Coronary Artery Bypass Graft Surgery, run by Foundation University Islamabad 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kashaf Nadeem, MS-CPPT (+923349058792, kashafnadeem460@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow Rate (time frame: 5 days). 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 15 Oct 2026.