Cystic FibrosisNCT07519460
Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough,in Cystic Fibrosis Patients
A study testing High-Frequency Chest Wall Oscillation and Concurrent Training in people with Cystic Fibrosis, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- High-Frequency Chest Wall Oscillation and Concurrent Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2026to 29 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Gulab Devi Hospital, Mayo Hospital Lahore.
Lahore, Punjab Province, 40100
Arjumand Bano, MS-CPPT, 03059551883, arjumand.bano@riphah.edu.pk
FILZA BUKHARI, MS-CPPT
About this study
Official title: Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough, Sputum, Exercise Tolerance and Respiratory Muscle Strength in Cystic Fibrosis Patients
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.
Read the 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
- Conditions
- Cystic Fibrosis
- Being tested
- High-Frequency Chest Wall Oscillation, Concurrent Training
- Keywords
- Cystic fibrosis High-frequency chest wall oscillation Concurrent training
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency Chest Wall OscillationDevice
Also called SmartVest, Monarch Airway Clearance System
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 TrainingBehavioural
Also called Aerobic and Resistance 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: High-Frequency Chest Wall Oscillation; Behavioral: Concurrent Training |
| 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. Receives: Device: High-Frequency Chest Wall Oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startApr 2026 (estimated)
- Primary completion28 May 2026 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519460
- Sponsor's protocol ID
- REC/RCR & AHS/25/0319
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough, Sputum, Exercise Tolerance and Respiratory Muscle Strength in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT07519460
- Acronym / sponsor ID
- REC/RCR & AHS/25/0319
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis High-frequency chest wall oscillation Concurrent training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HFCWO + Concurrent Training | Experimental | Device: High-Frequency Chest Wall Oscillation, Behavioral: Concurrent TrainingParticipants 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 |
| HFCWO Alone | Active comparator | Device: High-Frequency Chest Wall OscillationParticipants 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. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- Active hemoptysis or pneumothorax.
- Risk of hemodynamic instability or severe hypoxia.
- Acute airway infection.
- Cognitive disorders affecting compliance.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Frequency Chest Wall OscillationAlso: SmartVest, Monarch Airway Clearance SystemHigh-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 | Device | HFCWO + Concurrent Training, HFCWO Alone |
| Concurrent TrainingAlso: Aerobic and Resistance TrainingConcurrent 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 | Behavioural | HFCWO + Concurrent Training |
Primary outcome
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.
1 secondary outcome
Change in Pulmonary Function
Time frame: Baseline and after 8 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjumand Bano, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Frequency Chest Wall Oscillation and Concurrent Training in people with Cystic Fibrosis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Iqbal Tariq, Phd* (333826752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cough Severity (time frame: Baseline and after 8 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.