Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough, Sputum, Exercise Tolerance and Respiratory Muscle Strength in Cystic Fibrosis Patients
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Cough Severity
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
Eligibility Criteria
- Ages
- 16 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: High-Frequency Chest Wall Oscillation (Device)
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
Intervention: Concurrent Training (Behavioral)
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.
Intervention: High-Frequency Chest Wall Oscillation (Device)
Outcomes
Primary Outcomes
Change in Cough Severity
Time Frame: Baseline and after 8 weeks of intervention
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
Time Frame: Baseline and after 8 weeks of intervention
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(Baseline and after 8 weeks of intervention)