Идёт набор NCT04615130

PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome

Без фазы С лечением Pulmonary Embolism

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: Rehabilitation.
Кому может быть актуально: Состояния в реестре: Pulmonary Embolism. Базовые параметры: 18 лет — 90 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: Австрия
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

Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study

Обзор

This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism. Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.

Вмешательства

Другое Rehabilitation
Rehabilitation, exercise training

Первичные конечные точки

6-Minute Walk Test [Срок оценки: within the 6-week study period]

Вторичные конечные точки (12)

peak oxygen consumption [Срок оценки: within the 6-week study period]
Maximal workload [Срок оценки: within the 6-week study period]
One-repetition maximum for lower extremities [Срок оценки: within the 6-week study period]
One-repetition maximum for upper extremities [Срок оценки: within the 6-week study period]
Maximal inspiratory muscle pressure [Срок оценки: within the 6-week study period]
Inspiratory muscle endurance [Срок оценки: within the 6-week study period]
Level of dyspnea [Срок оценки: within the 6-week study period]
Health related quality of life [Срок оценки: within the 6-week study period]
Disease related quality of life [Срок оценки: within the 6-week study period]
Functional limitations [Срок оценки: within the 6-week study period]
Functional status [Срок оценки: within the 6-week study period]
Anxiety and depression [Срок оценки: within the 6-week study period]

Критерии участия

Критерии включения

Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:

Post-PE functional impairment criteria
Post-PE Cardiac Impairment criteria
Chronic Thromboembolic Disease criteria
Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE

Критерии исключения

CTEPH diagnosis
Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
Active cancer
Pregnancy
Myocardial infarction or cardiac surgery one year prior to inclusion
Congenital heart disease, congestive heart failure
History of stroke
Any previous inpatient or outpatient PR

Additional criteria that are absolute contraindications for pulmonary rehabilitation

Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)
open tuberculosis
active infectious diseases and acute inflammatory processes
Stressful and time-consuming therapy that significantly impair the ability to rehabilitate (e.g. chemotherapy or radiation therapy after malignancy)
Participants who are not sufficiently resilient due to physical or mental impairment and / or cannot be mobilized and therefore cannot actively use the rehabilitation facility
lack of motivation for therapy
massive incontinence
drugs and alcohol addiction

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

Здоровые добровольцы: Нет