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Additional Effects of Flutter With Conventional Chest Physiotherapy on Peak Expiratory Flow Rate and Chest Expansion in Post CABG Patients With COPD

Additional Effects of Flutter With Conventional Chest Physiotherapy on Peak Expiratory Flow Rate and Chest Expansion in Post CABG Patients With COPD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07875049
Enrollment
84
Registered
2026-10-15
Start date
2026-02-11
Completion date
2026-12-20
Last updated
2026-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery, Chronic Obstructive Pulmonary Disease

Keywords

Conventional Chest Physiotherapy, Chest Expansion, Flutter

Brief 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. 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.

Interventions

1. 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.

DEVICEFlutter device with conventional chest physiotherapy

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.

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded to group allocation throughout the assessment period. The assessor will not be involved in intervention delivery or participant allocation and will perform the outcome assessments independently to minimize the risk of measurement and observer bias. Due to the nature of the physiotherapy interventions, blinding of participants and the treating physiotherapist will not be feasible.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Peak Expiratory Flow Rate5 daysPeak 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 Expansion5 daysMeasured using measuring tape at the axillary, mid thoracic/sternal, and xiphoid levels by recording chest circumference at inspiration and expiration.

Secondary

MeasureTime frameDescription
Total Expectorated Sputum Volume (mL)5 daysAirway 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.
Dyspnea5 daysDyspnea 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.
Breathlessness, Cough and Sputum Scale (BCSS) Total Score5 daysRespiratory 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.

Countries

Pakistan

Contacts

CONTACTKashaf Nadeem, MS-CPPT
kashafnadeem460@gmail.com+923349058792
CONTACTSyeda Sumaira Batool, MS-CPPT
sumaira.batool@fui.edu.pk+923328868680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 16, 2026