The Effect of Home-based Inspiratory Muscle Training Compared to Usual Care on Readmission Rate in Patients After a Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomised, Multicentre, Parallel Group Clinical Trial: IN-SPIRED Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 358
- 试验地点
- 12
- 主要终点
- Composite outcome (all-cause hospital readmission or mortality)
研究概览
简要总结
The goal of this clinical trial is to test whether home-based inspiratory muscle training can reduce hospital readmissions and death in patients recovering from a severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
The main questions this study aims to answer are:
Does adding home-based inspiratory muscle training to usual care lower the risk of all-cause hospital readmission or death within 180 days after discharge? Does inspiratory muscle training improve respiratory muscle strength, symptoms of dyspnea, quality of life, and functional capacity compared to usual care?
Researchers will compare patients randomized to:
Intervention group: Home-based inspiratory muscle training plus usual care Control group: Usual care only
to see if inspiratory muscle training leads to fewer readmissions and deaths, and better patient-reported and physiological outcomes.
Participants will:
Be hospitalized for ≥3 days due to AECOPD, age ≥35 years, able to consent, and own a compatible smartphone.
In the intervention group, receives usual care and additionally inspiratory muscle training:
Inspiratory muscle training twice daily for 90 days, then once daily up to day 180, with remote telemonitoring via a smartphone app and online supervised sessions.
The control group will continue with usual care (pharmacological treatment, smoking cessation advice, vaccinations, and referral to pulmonary rehabilitation if available).
Follow-up assessments will include hospital readmissions, survival, and quality of life questionnaires up to 12 months after discharge.
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
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the hospital ≥3 days for AECOPD
- •Read and speak French, Dutch or English
- •Age ≥ 35 years
- •Able to provide informed consent
- •Possessing a smartphone, compatible with the tele-monitoring app and able to perform video meetings.
排除标准
- •Patients already performing IMT at time of inclusion
- •Patients with estimated <90 days life expectancy
- •Non-COPD pulmonary disease as primary diagnosis
- •Active malignancy
- •Inability to perform IMT or response to questionnaires (e.g., neurological/cognitive impairment)
- •Acute instable cardiac arrythmia or ischemia
- •Acute pneumothorax
- •Planned lung volume reduction procedure <180days
- •Waitlisted for lung transplantation
- •Patients admitted to an in-hospital rehabilitation ward
- •Patients included in other interventional trial related to COPD that would interfere with our trial outcomes.
研究组 & 干预措施
Control
Patients will receive usual care, including optimal pharmacological therapy per international guidelines, advise on smoking cessation, vaccination, and physical activity participation and advised to attend physiotherapy or a respiratory rehabilitation program based on accessibility and patient preference.
Intervention
干预措施: Training (Other)
结局指标
主要结局
Composite outcome (all-cause hospital readmission or mortality)
时间窗: within 180 days after hospital discharge
次要结局
- Composite outcome (all-cause hospital readmission or mortality)(within 90 days after hospital discharge)
- Time-to-composite outcome (all-cause hospital readmission or mortality)(within 180 days after hospital discharge)
- Hospital re-admission(Day 28, 90 and 180 after hospital discharge)
- All-cause mortality(Day 28, 90 and 180 after hospital discharge)
- Primary care and specialty consultationsc(Day 90 and 180 after hospital discharge)
- Re-exacerbation(Day 90 and 180 after hospital discharge)
- Change in Forced Expiratory Volume in 1 Second (FEV₁), liters(Day 90 and 180 after hospital discharge)
- Change in Forced Expiratory Volume in 1 Second (FEV₁), %pred(Day 90 and 180 after hospital discharge)
- Change in Forced Vital Capacity (FVC), liters(Day 90 and Day 180 after hospital discharge)
- Change in Forced Vital Capacity (FVC), %predicted(Day 90 and Day 180 after hospital discharge)
- Change in FEV₁/FVC Ratio (%)(Day 90 and Day 180 after hospital discharge)
- Change in Functional Residual Capacity (FRC), liters(Day 180 after hospital discharge)
- Change in Functional Residual Capacity (FRC), %predicted(Day 180 after hospital discharge)
- Change in Residual Volume (RV), liters(Day 180 after hospital discharge)
- Change in Residual Volume (RV), % predicted(Day 180 after hospital discharge)
- Change in Total Lung Capacity (TLC), liters(Day 180 after hospital discharge)
- Change in Total Lung Capacity (TLC), %predicted(Day 180 after hospital discharge)
- Maximal inspiratory pressure (PImax)(Day 90 and 180 after hospital discharge)
- Baseline/Transition Dyspnea Index (BDI/TDI)(Day 28, 90, 180 after hospital discharge)
- EQ-5D-5L questionnaire(Day 28, 90, 180 after hospital discharge)
- COPD Assessment test (CAT)(Day 28, 90, 180 after hospital discharge)
- Adverse events(Day 90, 180 after hospital discharge)
- Serious adverse events(Day 90 and 180 after hospital discharge)
研究者
Daniel Langer
associate professor Faculty of Movement and Rehabilitation Sciences
KU Leuven