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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Function | Pulmonary function will be measured using spirometry, including FEV1 and FVC values | Baseline and after 8 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Iqbal Tariq, Phd* | Contact | 333826752 | iqbal.tariq@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Arjumand Bano, MSPT | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulab Devi Hospital, Mayo Hospital Lahore. | Lahore | Punjab Province | 40100 | Pakistan |
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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.
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Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
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| 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 |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D035641 | Chest Wall Oscillation |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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