- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04022369
The Effects of an Exercise Programme for Older Patients With Heart Failure
The Effects of an Exercise Empowerment Programme for Older Patients With Heart Failure: A Randomized Controlled Trial
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Patients with heart failure have decreased exercise tolerance, balance problems, and fall risks. The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure.
This randomized, controlled study including pre-test/post-test and the measurements were performed between January-November 2014 at a university hospital in Izmir, Turkey. Intervention group (n = 11) and control group (n = 10) participated in the research. The intervention group received 45-60 minute individual training and 12 weeks of individual follow-up. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. Patients in the control group did not receive any intervention except for their routine treatment. Data were collected before the education of exercise and after 12 weeks; sociodemographic data questionnaire, pedometer, accelerometer, Berg Balance Scale, HF Empowerment Scale, estimated weekly exercise monitoring form and exercise booklet had been utilised. The SPSS statistical package program was used to analyze the data.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- were aged 60 years or older
- independent
- literate
- able to communicate verbally
- participating voluntarly in the study
Exclusion Criteria:
- were having a diagnosis of psychiatric illness
- a visual or auditory impairment
- previously participated in another exercise program
- any contraindication to exercise (uncontrolled arrhythmia, hypertension and metabolic illness, ejection fraction)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Exercise Group
The intervention group received 45-60 minute of individual training and a handbook for the exercise program was given.
These patients were followed for a total of 12 weeks.
The exercise program was developed by reviewing the literature part on physical activity for senior citizens with heart failure.
Education program based on Empowerment model.
Weekly motivational telephone interviews were conducted with the patients, and the home visits and telephone interviews were repeated when belived necessary.
The purpose of the study were explained to all individuals involved in the study.
Body movements, balance levels, exercise durations, and strengths of individuals before exercise program and after exercise program were evaluated.
A booklet demonstrating the exercises was given to the patients to enhance their understanding, and they were allowed to ask questions about the exercise program during the training.
|
The intervention group received 45-60 minute of individual training and a handbook for the exercise program was given.
These patients were followed for a total of 12 weeks.
The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated.
The exercise program was developed by reviewing the literature part on physical activity for senior citizens with heart failure.
The program was established on evidence-based recommendations for the cardiac rehabilitation of patients with HF.
Each session included warm-up and cool-down exercises, moderate walking, and balance exercises.
Другие имена:
|
Без вмешательства: Control Group
The patients in the control group continued their standard treatment and care.
Data collection forms were applied to the patients in the control group at the first month and 12 weeks after discharge.
After the study was completed, all patients in the control group were provided with home-based exercise training booklets.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Group (empowerment evaluation scale assessment)
Временное ограничение: 3 months
|
Old patients were observed and evaluated daily activities during 12 weeks.
The exercise program was established on evidence-based recommendations for patients with Heart Failure (HF).
Empowerment level of individuals before and after exercise program were evaluated.
Empowerment is a model aiming to protect patients' rights and develop the quality of care.
This model is aimed at giving individuals a feeling of success and improving their self image, and is intended to make necessary lifestyle changes easier and more lasting.
Subscales of the empowerment are "Managing the Psychosocial Aspects of Heart Failure", "Assessing Dissatisfaction and Readiness to Change" and "Setting and Achieving Heart Failure Goals".
The Scale evaluated has 28 items and five-way likert-type.
Scores range from 28 to 140, scores of 28-65 classified as low, 66-103 as medium, and 104-140 as high.
|
3 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Control Group (empowerment evaluation scale assessment)
Временное ограничение: 3 months
|
The patients in the control group continued their routine treatment and daily living activities.
These patients were observed and evaluated daily activities during 12 weeks.
Empowerment level of the individuals before and after 12 weeks were evaluated.
Empowerment is a model aiming to protect patients' rights and develop the quality of care.
This model is aimed at giving individuals a feeling of success and improving their self image, and is intended to make necessary lifestyle changes easier and more lasting.
Subscales of the empowerment are "Managing the Psychosocial Aspects of Heart Failure", "Assessing Dissatisfaction and Readiness to Change" and "Setting and Achieving Heart Failure Goals".
The Scale evaluated has 28 items and five-way likert-type.
Scores range from 28 to 140, scores of 28-65 classified as low, 66-103 as medium, and 104-140 as high.
|
3 months
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Zehra Çiçek FADILOĞLU, Emertus, Ege University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 12-9/7
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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