About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Active hemoptysis or pneumothorax.
Risk of hemodynamic instability or severe hypoxia.
Acute airway infection.
Cognitive disorders affecting compliance.
Trial design
Parallel
Treatments tested in this trial
High-Frequency Chest Wall Oscillation
DeviceHigh-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
Concurrent Training
BehavioralConcurrent 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Change in Exercise Tolerance
Exercise tolerance will be measured by distance covered during the 6-minute walk test to assess functional exercise capacity.
Secondary outcomes
Change in Pulmonary Function
Pulmonary function will be measured using spirometry, including FEV1 and FVC values
Sponsors and contacts
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