Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough,in Cystic Fibrosis Patients

Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough, Sputum, Exercise Tolerance and Respiratory Muscle Strength in Cystic Fibrosis Patients

This randomized clinical trial aims to evaluate the effects of high-frequency chest wall oscillation (HFCWO) combined with concurrent training on cough, sputum clearance, exercise tolerance, and respiratory muscle strength in patients with Cystic Fibrosis. A total of 24 participants meeting inclusion criteria will be randomly allocated into two groups: Group A will receive HFCWO plus concurrent training, while Group B will receive HFCWO alone for 8 weeks. Outcomes will be measured before and after intervention using the 6-minute walk test, spirometry, Leicester Cough Questionnaire, sputum volume, and the Cystic Fibrosis Questionnaire-Revised. The study will be conducted at Pulmonary Rehabilitation Unit, Gulab Devi Hospital and Mayo Hospital, Lahore. Statistical analysis will be performed using IBM SPSS Statistics, with significance set at p < 0.05.

Study Overview

• Status: Not yet recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: High-Frequency Chest Wall Oscillation; Behavioral: Concurrent Training

Detailed Description

This randomized clinical trial will evaluate the effects of high-frequency chest wall oscillation (HFCWO) combined with concurrent training on cough, sputum clearance, exercise tolerance, respiratory muscle strength, and quality of life in patients with Cystic Fibrosis. Cystic fibrosis causes thick mucus accumulation in the lungs, leading to chronic infections, airway obstruction, and reduced pulmonary function.

A total of 24 participants will be recruited and randomly divided into two groups. Group A will receive HFCWO combined with aerobic and resistance training, while Group B will receive HFCWO alone for 8 weeks. HFCWO will be applied using the SmartVest/Monarch system for 20 minutes per session, while concurrent training will include treadmill walking and resistance exercises.

Outcome measures will be assessed before and after treatment using the 6-minute walk test, spirometry, Leicester Cough Questionnaire, sputum volume, and the Cystic Fibrosis Questionnaire-Revised. The study will be conducted at Gulab Devi Hospital and Mayo Hospital, and data will be analyzed using IBM SPSS Statistics with significance set at p < 0.05

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Iqbal Tariq, Phd*; Phone Number: 333826752; Email: iqbal.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 40100
      • Gulab Devi Hospital, Mayo Hospital Lahore.
      • Contact: Arjumand Bano, MS-CPPT; Phone Number: 03059551883; Email: arjumand.bano@riphah.edu.pk
      • Principal Investigator: FILZA BUKHARI, MS-CPPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with Cystic Fibrosis, confirmed by genotype or sweat chloride >60 mmol/L.
• Age 16-35 years.
• Both male and female participants.
• Stable clinical condition (no exacerbations in the last 2 weeks).
• Forced expiratory volume in 1 second (FEV₁ ≥ 20% predicted).

Exclusion Criteria:

• Active hemoptysis or pneumothorax.
• Risk of hemodynamic instability or severe hypoxia.
• Acute airway infection.
• Cognitive disorders affecting compliance.
• Pregnancy.
• Cardiac diseases such as heart failure or arrhythmias.
• Neurological or orthopedic illnesses or recent chest injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFCWO + Concurrent Training; Participants in this group will receive high-frequency chest wall oscillation (HFCWO) using the SmartVest/Monarch system at 12-15 Hz and 10-20 cm H₂O pressure for 20 minutes per session, combined with aerobic and resistance training for 8 weeks. Aerobic training will include treadmill walking, and resistance exercises will include lat pulldown, leg press, chest press, shoulder press, and sit-ups	Device: High-Frequency Chest Wall Oscillation; High-frequency chest wall oscillation will be administered using the SmartVest/Monarch system at a frequency of 12-15 Hz and pressure of 10-20 cm H₂O for 20 minutes per session in an upright sitting position, three times per week for 8 weeks. The intervention is used to mobilize airway secretions and improve mucus clearance in patients with Cystic Fibrosis; Other Names: SmartVest, Monarch Airway Clearance System; Behavioral: Concurrent Training; Concurrent training will include aerobic treadmill walking at 70-85% of maximum heart rate and resistance exercises including lat pulldown, leg press, chest press, shoulder press, and sit-ups. Sessions will be performed twice weekly for 8 weeks to improve exercise tolerance and respiratory muscle strength; Other Names: Aerobic and Resistance Training
Active Comparator: HFCWO Alone; Participants in this group will receive only high-frequency chest wall oscillation (HFCWO) using the SmartVest/Monarch system at 12-15 Hz and 10-20 cm H₂O pressure for 20 minutes per session for 8 weeks.	Device: High-Frequency Chest Wall Oscillation; High-frequency chest wall oscillation will be administered using the SmartVest/Monarch system at a frequency of 12-15 Hz and pressure of 10-20 cm H₂O for 20 minutes per session in an upright sitting position, three times per week for 8 weeks. The intervention is used to mobilize airway secretions and improve mucus clearance in patients with Cystic Fibrosis; Other Names: SmartVest, Monarch Airway Clearance System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cough Severity	Cough severity will be assessed using the Leicester Cough Questionnaire to evaluate changes in physical, psychological, and social impact of cough after intervention.	Baseline and after 8 weeks of intervention
Change in Exercise Tolerance	Exercise tolerance will be measured by distance covered during the 6-minute walk test to assess functional exercise capacity.	Baseline and after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Function	Pulmonary function will be measured using spirometry, including FEV1 and FVC values	Baseline and after 8 weeks of intervention

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Arjumand Bano, MSPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cystic fibrosis High-frequency chest wall oscillation Concurrent training
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cystic Fibrosis; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Respiratory Therapy; Exercise; Resistance Training; Chest Wall Oscillation
• Other Study ID Numbers: REC/RCR & AHS/25/0319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No