Effects of High-Frequency Chest Wall Oscillation Combined With Concurrent Training on Cough, Sputum, Exercise Tolerance and Respiratory Muscle Strength in Cystic Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Cough Severity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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
干预措施: 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
干预措施: 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.
干预措施: High-Frequency Chest Wall Oscillation (Device)
结局指标
主要结局
Change in Cough Severity
时间窗: 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
时间窗: 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.
次要结局
- Change in Pulmonary Function(Baseline and after 8 weeks of intervention)