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

NCT07875049 | Recruiting

• 1 other identifier: KashafNadeemCPT/FUCP-27
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Conventional Chest Physiotherapy; Chest Expansion; Flutter

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  5 days

Secondary Outcomes (3)

• Total Expectorated Sputum Volume (mL)

  5 days

• Dyspnea

  5 days

• Breathlessness, Cough and Sputum Scale (BCSS) Total Score

  5 days

Study Arms (2)

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

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.

Device: Flutter device with conventional chest physiotherapy

Interventions

Conventional Chest Physiotherapy PROCEDURE

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.

Group A: conventional chest physiotherapy

Flutter device with conventional chest physiotherapy DEVICE

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.

Group B: Flutter therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Rawalpindi, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kashaf Nadeem, MS-CPPT

CONTACT

+923349058792; kashafnadeem460@gmail.com

Syeda Sumaira Batool, MS-CPPT

CONTACT

+923328868680; sumaira.batool@fui.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 15, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

PA (1)