Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Lung Clearance Index
研究概览
简要总结
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials.
Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.
Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.
Analysis will be based upon differences in outcome measures and in-between study days.
详细描述
Research Question: Does the use of a new assessment tool box (Electronic Impedance Tomography (EIT), Lung Clearance Index (LCI), Impulse Oscillation System (IOS)) give results that are more sensitive to change for the effect of an airway clearance technique (ACT) (the Active Cycle of Breathing Techniques (ACBT)) while having low variability and good repeatability in stable adult patients with cystic fibrosis (CF) than the traditional gold standard outcome measures of forced expiratory volume in one second (FEV1) and sputum wet weight?
Hypothesis: The use of a new outcome assessment tool box will allow more sensitive information about the effects of ACTs in stable adult patients with CF than the current gold standard measures.
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London. Participants will be their own controls. Each participant will attend the research facility for two visits. Prior to starting the study assessment session participants will be questioned to ensure they are in a stable state of their disease (characterised by symptoms and having had no treatment changes for 28 days prior to the visit). All participants will continue with the timing and prescribed dosing of all inhaled medications as directed prior to the study. Subjects will be their own controls. Subjects will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising the Active Cycle of Breathing Techniques (ACBT) supervised by a specialist physiotherapist in adult CF. The ACT session will last for thirty minutes minimum, to 60 minutes maximum until a consensus is reached between participant and physiotherapist that the participant's chest is clear.
Subjects will perform the OM tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated immediately after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be given for completion after the last OM test is completed on each study visit.
There are no planned follow up measurements for participants in this study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF (confirmed by standard criteria)
- •Sixteen years of age or over
- •Patients in a stable state (characterised by no required therapy changes within 28 days of visit and patient symptoms)
排除标准
- •Current infective exacerbation or reduction in lung function requiring therapeutic intervention
- •Current moderate haemoptysis (greater than streaking in the sputum)
- •Current dependency on positive pressure support with ACT
- •Previous history of spontaneous rib fractures
- •Pregnancy
- •Inability to give consent for treatment or measurement
- •Current participation in another interventional study
- •Current dependency upon non-invasive ventilation
- •Current dependency upon oxygen therapy
研究组 & 干预措施
Visit A
Rest period for 30-60 minutes
干预措施: Rest period (Other)
Visit B
Airway clearance session utilising the Active Cycle of Breathing techniques (ACBT) supervised by a specialist physiotherapist for 30-60 minutes.
干预措施: Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) (Procedure)
结局指标
主要结局
Change in Lung Clearance Index
时间窗: Immediately pre-intervention and immediately post-intervention
This is a technique which involves breathing quietly through a tube whilst wearing nose clips. The test measures harmless tracer gases which are breathed in and out and measured by a sensitive gas-detection system. The LCI is calculated based on how long it takes for the gas to be breathed out from the lungs, and it shows if there are areas within the lung that are working less efficiently than others, for example when areas of the lung are clogged with mucus.
Change in Forced Expiratory Volume in One Second
时间窗: Immediately pre-intervention and immediately post-intervention
A forced expiratory manoeuvre into a spirometer (value derived from 1 second blow)
Electronic Impedance Tomography
时间窗: During intervention
This technique involves wearing a belt around the chest which has electrodes attached to it. Undetectable alternating electrical currents are then applied to the electrodes, which the participant will not be able to feel. The machine measures how easy or difficult it is for that current to travel through the lungs and any differences are calculated, giving a picture of the ventilation of the lung.
Change in Impulse Oscillation System
时间窗: Immediately pre-intervention and immediately post-intervention
The Impulse Oscillation system is a non-invasive technique where the participant breathes normally through a mouthpiece whilst wearing a nose clip, into a machine which produces small pressure vibrations (oscillations). The machine measures these vibrations and any changes to them to give an idea of obstructions to the airways, for example any mucus clogging.
Sputum Wet Weight
时间窗: During intervention and for 30 minutes post-intervention
Amount of sputum expectorated will be measured in a pre-weighed pot
次要结局
- Oxygen saturation measurements(During interventions)
- Change in Forced Vital Capacity(Immediately pre-intervention and immediately post-intervention)
- Change in Forced Expiratory Flow at 25% of Forced Vital Capacity(Immediately pre-intervention and immediately post-intervention)
- Change in Forced Expiratory Flow at 50% of Forced Vital Capacity(Immediately pre-intervention and immediately post-intervention)
- Change in Forced Expiratory Flow at 75% of Forced Vital Capacity(Immediately pre-intervention and immediately post-intervention)
- Patient feedback questionnaire(Straight after the intervention)