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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: HFCWO + Concurrent TrainingExperimental treatment 2 interventions
Group B: HFCWO AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and after 8 weeks of intervention
2

Change in Exercise Tolerance

Exercise tolerance will be measured by distance covered during the 6-minute walk test to assess functional exercise capacity.

Time frame
Baseline and after 8 weeks of intervention

Secondary outcomes

1

Change in Pulmonary Function

Pulmonary function will be measured using spirometry, including FEV1 and FVC values

Time frame
Baseline and after 8 weeks of intervention

Other outcomes

Sponsors and contacts

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