Идёт набор NCT06951633

Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.

Без фазы С лечением the Elderly Respiratory Disorders

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: Subterranean, pulmonary rehabilitation.
Кому может быть актуально: Состояния в реестре: the Elderly, Respiratory Disorders. Базовые параметры: от 65 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: Польша
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Functional Efficiency, Respiratory Parameters and Blood Rheological Tests in Elderly People With Respiratory Diseases Participating in Pulmonary Rehabilitation in Underground Salt Chambers - a Prospective Experimental Study, Controlled in a Crossover Design

Обзор

The aim of the study is to assess the impact of the rehabilitation and treatment stay at the underground Health Resort of the 'Wieliczka' Salt Mine in Wieliczka on the functional capacity, respiratory parameters, and rheological properties of blood in elderly individuals with respiratory diseases.

Подробное описание

The research project will involve patients aged 65 and older with chronic respiratory diseases. Based on controlled studies conducted at the Health Resort "Wieliczka" Salt Mine in Wieliczka, and assuming the project will be a prospective, experimental, controlled study with a crossover design, calculations were made for the primary variable under investigation (exercise tolerance). These calculations determined that 29 pairs of participants are needed to achieve a statistical power of 80% and a significance level of 5% (bilateral). To detect a mean difference between pairs of 58, assuming a standard deviation of 106 for these differences and accounting for a 10% loss of participants from observation, the required sample size was increased to 33 pairs. Given the crossover design, the study plans to include 33 patients.

Volunteers will undergo qualifying tests, measurements of functional fitness, respiratory indicators, and blood rheology tests 3 weeks prior to the start of the rehabilitation and therapeutic stay in the underground salt chambers (1st test). During the 3-week period before the rehabilitation, participants will not engage in any other form of therapeutic rehabilitation. Functional fitness, respiratory indicators, and blood rheology tests will be repeated before the start of the stay (2nd test), immediately after its completion (3rd test), and 3 months after its completion (4th follow-up test). Each day of the rehabilitation and therapeutic stay will include a 2.5-hour visit to the underground health resort under the supervision of a doctor, physiotherapist, and nurse, during which pulmonary rehabilitation will be implemented.

Вмешательства

Другое Subterranean, pulmonary rehabilitation
Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine

Первичные конечные точки

Respiratory muscle force: Maximal inspiratory pressure - MIP [Срок оценки: up to 18 months]
Respiratory muscle force: Maximal expiratory pressure - MEP [Срок оценки: up to 18 months]
Respiratory muscle force: Sniff Nasal Inspiratory Pressure - SNIP [Срок оценки: up to 18 months]
6-Minute Walk Test - 6MWT [Срок оценки: up to 18 months]
The Aggregation Index (AI) [Срок оценки: up to 18 months]
The half-time of total aggregation (T1/2) [Срок оценки: up to 18 months]
The Elongation Index (EI) [Срок оценки: up to 18 months]
4- Meters Gait Speed Test - 4MGST [Срок оценки: up to 18 months]
Health Related Quality of Life - HRQoL withe the use of 15D questionnaire. [Срок оценки: up to 18 months]
Chest mobility [Срок оценки: up to 18 months]

Вторичные конечные точки (6)

FEV₁ [Срок оценки: 2 weeks]
FVC [Срок оценки: 2 weeks]
PEF [Срок оценки: 2 weeks]
Bronchodilator Reversibility (BDR) Test [Срок оценки: 2 weeks]
Resting tongue posture [Срок оценки: 2 weeks]
3-Day Food Diary [Срок оценки: up to 18 months]

Критерии участия

Критерии включения

people aged 65 and older with chronic respiratory diseases in a stable period of the disease (without exacerbations), qualified to participate in a rehabilitation and treatment stay in the underground Health Resort 'Wieliczka' Salt Mine in Wieliczka,
patients who gave informed, written consent to participate in the study.