Cystic Fibrosis
Conditions
Keywords
Cystic fibrosis High-frequency chest wall oscillation Concurrent training
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
Interventions
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
BEHAVIORALConcurrent 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
Sponsors
Riphah International University
Study design
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cough Severity | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Function | Baseline and after 8 weeks of intervention | Pulmonary function will be measured using spirometry, including FEV1 and FVC values |
Countries
Pakistan
Contacts
CONTACTMuhammad Iqbal Tariq, Phd*
PRINCIPAL_INVESTIGATORArjumand Bano, MSPT
Riphah International University
Outcome results
None listed