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

NCT07519460 | Not Yet Recruiting

• 1 other identifier: REC/RCR & AHS/25/0319
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis High-frequency chest wall oscillation Concurrent training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Pulmonary Function

  Baseline and after 8 weeks of intervention

Study Arms (2)

HFCWO + Concurrent Training

EXPERIMENTAL

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; Behavioral: Concurrent Training

HFCWO Alone

ACTIVE COMPARATOR

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

Interventions

High-Frequency Chest Wall Oscillation DEVICE

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

Also known as: SmartVest, Monarch Airway Clearance System

HFCWO + Concurrent Training; HFCWO Alone

Concurrent Training BEHAVIORAL

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

Also known as: Aerobic and Resistance Training

HFCWO + Concurrent Training

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Hospital, Mayo Hospital Lahore.

Lahore, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Chest Wall Oscillation; Resistance Training

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Arjumand Bano, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Iqbal Tariq, Phd*

CONTACT

333826752; iqbal.tariq@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned into two parallel groups. Group A will receive high-frequency chest wall oscillation (HFCWO) combined with concurrent training, while Group B will receive HFCWO alone for 8 weeks. Outcomes will be measured at baseline and after intervention to compare treatment effects.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 1, 2026
• Primary Completion: May 28, 2026
• Study Completion: May 29, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)