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NCT Number: NCT07519460

Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough,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.

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Key information

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Hospital, Mayo Hospital Lahore.

Lahore, Punjab Province, 40100, Pakistan

Location contact

Arjumand Bano, MS-CPPT

CONTACT

[email protected]

03059551883

FILZA BUKHARI, MS-CPPT

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: SmartVest, Monarch Airway Clearance System

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

Other names: Aerobic and Resistance Training

Primary outcomes

  1. 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.

  2. 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

  1. Change in Pulmonary Function

    Time frame: Baseline and after 8 weeks of intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Iqbal Tariq, Phd*

CONTACT

[email protected]

333826752

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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