Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease

Официальное название

Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial

Обзор

The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.

Подробное описание

The fibrotic interstitial lung diseases (f-ILD) are a group of progressive and debilitating lung diseases sharing characteristics of lung scarring on imaging and restricted breathing on pulmonary function testing (PFT). Symptoms include shortness of breath, cough, and fatigue, eventually leading to deconditioning and poor quality of life. While medical therapies are available for slowing or stopping the loss of lung function, only pulmonary rehabilitation (PR) has shown a positive impact on patient-reported shortness of breath and physical activity. Unfortunately, PR may not be widely available to all patients, and some patients may become too ill to participate in traditional center-based programs.

A primary hypothesis is that modifying the content, delivery, and setting for PR in patients with f-ILD to improve access or ease of use and supporting behavior change through a health coach will have a measurable and sustained positive impact on patient well-being and quality of life as compared to no participation or non-use.

Вмешательства

• Поведенческое Home-based Pulmonary Rehab
  Participants are expected to engage in the home-based PR routine five to six days a week for the entire 12-week study period. The PR routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time is 24 minutes a day followed by a 4-minute mindful breathing meditation/cool down. Exercises may be modified or repeated according to baseline activity level and as conditioning improves.

Первичные конечные точки

• King's Brief Interstitial Lung Disease (K- BILD) [Срок оценки: Baseline, end of intervention (3 months), and 3 months post-intervention]
• Physical activity as measured by change in mean number of steps per day [Срок оценки: Baseline, end of intervention (3 months), and 3 months post-intervention]

Вторичные конечные точки (4)

• Modified Medical Research Council (mMRC) [Срок оценки: Baseline, end of intervention (3 months), and 3 months post-intervention]
• Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire [Срок оценки: Baseline, end of intervention (3 months), and 3 months post-intervention]
• FACIT Fatigue Scale [Срок оценки: Baseline, end of intervention (3 months), and 3 months post-intervention]
• Leicester Cough Questionnaire (LCQ) [Срок оценки: Baseline, end of intervention (3 months), and 3 months post-intervention]

Критерии участия

IInclusion Criteria:

• F-ILD diagnosis, any disease subtype, active or prior medical treatment
• >10% fibrosis on CT imaging
• mMRC dyspnea score >1
• All racial or ethnic categories, including non-English speakers (professional translators will be engaged to support screening, enrollment, and study participation)

Критерии исключения

• Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
• Cognitive impairment or inability to understand and follow instructions
• Traditional center-based PR completed within 3 months of initial study recruitment
• Transition to hospice or end-of-life care at the time of screening
• Acute exacerbation at the time of screening

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

США · 4 центра

• Mayo Clinic in Arizona — Scottsdale
• Mayo Clinic in Florida — Jacksonville
• University of Minnesota — Minneapolis
• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06751069 · 24-007966

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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