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Идёт набор NCT07164742

Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)

Без фазы С лечением TB - Tuberculosis TB TB Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 8 week (short arm) Intervention - pulmonary rehabilitation, 24 week (long arm) Intervention - pulmonary rehabilitation.
Кому может быть актуально
Состояния в реестре: TB - Tuberculosis, TB, TB Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial

Обзор

Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.

Подробное описание

8 weeks (short arm) or 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.

Objectives:

1. To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity. 2. To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs. 3. To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.

Вмешательства

  • Поведенческое 8 week (short arm) Intervention - pulmonary rehabilitation
    8 weeks (short arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.
  • Поведенческое 24 week (long arm) Intervention - pulmonary rehabilitation
    24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.

Первичные конечные точки

  • Six-Minute Walk Test (6MWT) distance (meters) [Срок оценки: 48 weeks post enrollment]
Вторичные конечные точки (12)
  • Six minute walk test (6MWT) distance (meters) [Срок оценки: 8,16 & 24 weeks post enrollment]
  • Absolute percent change in Mean Six minute walk test (6MWT) distance [Срок оценки: 8,16, 24 & 48 weeks post enrollment]
  • Proportion of Participants with change in Six minute walk test (6MWT) distance (meters) [Срок оценки: 8,16, 24 & 48 weeks post enrollment]
  • St. George's Respiratory Questionnaire (SGRQ) score [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Absolute change in score for St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Percent change in score for St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ) [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Modified Medical Research Council (mMRC) Dyspnoea Scale [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale [Срок оценки: 8,16,24 & 48 weeks post enrollment]
  • Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score [Срок оценки: 8,16,24 & 48 weeks post enrollment]

Критерии участия

Критерии включения

  • Age at least 18 years
  • Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease\*
  • Not completed more than 2 weeks of TB treatment
  • Receiving TB care at the outpatient clinics at the TB PuRe study sites
  • Willingness to complete 48 weeks of study evaluations.
  • Access to a smartphone.

Критерии исключения

  • Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise)
  • Multi or extensively drug-resistant TB disease\*
  • Extrapulmonary TB disease at any clinical sites without pulmonary involvement
  • TB meningitis or TB of the spine
  • Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure.
  • Karnofsky Score < 40 points
  • Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy
  • Bronchodilators and/or corticosteroids inhaled or otherwise.

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

Индия · 2 центра
  • Yenepoya (Deemed to be University — Mangalore
  • Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center — Pune

Идентификаторы

NCT: NCT07164742 · IRB00412142 · 1R01AI169588-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗