Effect of IMT in Patients After Acute Exacerbations of COPD

Официальное название

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

Обзор

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.

Вмешательства

• Другое Training
  home-based inspiratory muscle training (IMT) will be delivered using a portable IMT device connected via Bluetooth to a smartphone application that provides real-time feedback, adherence monitoring, and telemonitoring by the study team. Patients will train for 365 days following hospital discharge due to an acute exacerbation of COPD: * Intensive phase (Day 0-90): 2 daily sessions, each consisting of 30 breaths against an inspiratory load set by thetelemonitor, with regular online supervised IM

Первичные конечные точки

• Composite outcome (all-cause hospital readmission or mortality) [Срок оценки: within 180 days after hospital discharge]

Вторичные конечные точки (12)

• Composite outcome (all-cause hospital readmission or mortality) [Срок оценки: within 90 days after hospital discharge]
• Time-to-composite outcome (all-cause hospital readmission or mortality) [Срок оценки: within 180 days after hospital discharge]
• Hospital re-admission [Срок оценки: Day 28, 90 and 180 after hospital discharge]
• All-cause mortality [Срок оценки: Day 28, 90 and 180 after hospital discharge]
• Primary care and specialty consultationsc [Срок оценки: Day 90 and 180 after hospital discharge]
• Re-exacerbation [Срок оценки: Day 90 and 180 after hospital discharge]
• Change in Forced Expiratory Volume in 1 Second (FEV₁), liters [Срок оценки: Day 90 and 180 after hospital discharge]
• Change in Forced Expiratory Volume in 1 Second (FEV₁), %pred [Срок оценки: Day 90 and 180 after hospital discharge]
• Change in Forced Vital Capacity (FVC), liters [Срок оценки: Day 90 and Day 180 after hospital discharge]
• Change in Forced Vital Capacity (FVC), %predicted [Срок оценки: Day 90 and Day 180 after hospital discharge]
• Change in FEV₁/FVC Ratio (%) [Срок оценки: Day 90 and Day 180 after hospital discharge]
• Change in Functional Residual Capacity (FRC), liters [Срок оценки: Day 180 after hospital discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 12 центров

• AZORG — Aalst
• Campus Joseph Bracops, Hôpitaux Iris Sud — Anderlecht
• Centre Hospitalier Universitaire Saint-Pierre — Brussels
• Grand Hopial de Charleroi — Charleroi
• Universitair Ziekenhuis Antwerpen — Edegem
• AZ Maria Middelares — Ghent
• Universitair Ziekenhuis Gent — Ghent
• AZ Groeninge — Kortrijk
• … и ещё 4 центра

Идентификаторы

NCT: NCT07213128 · S68174 · INV23-1479 · S68174

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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