Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease (HBCKD)
24 марта 2015 г. обновлено: Lilian Cuppari, Federal University of São Paulo
Effects of Home-based or Center-based Aerobic Exercise on Physical Function, Nutritional Status Ans Cardiopulmonary Parameters in Patients With Chronic Kidney Disease
Patients will be randomly assigned to perform the training program in center or home-based . The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.
It will also constituted a control group remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
45
Фаза
- Непригодный
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 30 лет до 65 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Sedentary individuals with chronic kidney disease stages 3 or 4 disease;
- Both genders;
- Age between 30 and 65 years;
- Overweight (BMI> 25 kg/m2);
- With a negative stress test.
Exclusion Criteria:
- Patients with chronic obstructive pulmonary disease,
- class IV heart failure,
- myocardial infarction within the last 6 months,
- decompensated hypertension (systolic blood pressure> 180 mmHg or diastolic> 110 mmHg in the last 6 months),
- uncontrolled cardiac arrhythmia,
- decompensated diabetes mellitus (glycated hemoglobin> 8.0%),
- unstable angina,
- infectious processes in the last 3 weeks;
- begin use of erythropoietin or with hemoglobin <11g/L.
- use of beta-blocker medication
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: sedentary control
|
|
|
Экспериментальный: Home-based aerobic exercise
The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine.
All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).
The program will consist of 24 weeks with three sessions per week on alternate days.
The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks.
The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways.
The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
The home-based exercise group exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.
|
|
|
Активный компаратор: Center-based aerobic exercise
The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine.
All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).
The program will consist of 24 weeks with three sessions per week on alternate days.
The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks.
The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways.
The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cardiopulmonary capacity
Временное ограничение: 24 weeks
|
The test began with a fixed inclination of 1%.
The initial velocity was 2 km/h during the first three minutes with increments of 0.5km/h every minute until the patient reaches physical exhaustion.
The ventilatory variables were measured using a gas analyzer.
The highest oxygen uptake obtained during the last stage reached was considered the peak oxygen uptake.
The ventilatory threshold was determined as the stage preceding the first occurrence of the exponential increase in ventilation, increase in the ventilatory equivalent for oxygen and increase in expired fraction of oxygen.
The respiratory compensation point was determined as the stage preceding the second occurrence of the exponential increase in ventilation, increase in the ventilatory equivalent for carbon dioxide and decrease in end-tidal carbon dioxide.
Data were analyzed by the average of 20 seconds.
|
24 weeks
|
|
Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go)
Временное ограничение: 24 weeks
|
Functional capacity was assessed using a variety of objective measures.
These included six-minute walk test (maximal distance walked along an internal corridor during six minutes), two-minute step test (maximal number of steps achieved in stationary walking during two minutes, used to quantifying the aerobic power), sit-to-stand test (maximal sit to stand cycles achieved in 30 seconds, used to quantifying the muscular endurance of the legs), arm curl test (maximal number of arm curl cycles in 30 seconds, used to quantifying the muscular endurance of the arms), sit and reach test (maximal distance achieved in the Wells bench, used to quantifying the general flexibility), back scratch test (maximum amplitude of the arms used to quantifying the arms flexibility) and time up and go test (shorter time to rise from a chair, walk three meters and sit back, used to quantifying the functional mobility).
|
24 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quality of life
Временное ограничение: 24 weeks
|
The Short-Form Health Survey (SF-36) questionnaire was applied to assess the quality of life.
The scores for each domain range from 0 to 100%.
The higher scores define a better quality of life.
The questionnaire was applied individually in a clear and quiet room with the patient rested.
|
24 weeks
|
|
sleep quality (PSQI)
Временное ограничение: 24 weeks
|
The PSQI assesses the quality of sleep for the last month of the interview.
The questionnaire has 19 questions that comprise seven assessment components: quality of sleep, latency, duration, efficiency, nocturnal sleep disturbances, use of sleep medication and daytime sleepiness.
Each component receives a score from 0 to 3, in a way that the final score can range between 0 and 21.
The higher the score, the worse the quality of sleep, and scores higher than five indicate sleep disturbances.
|
24 weeks
|
|
blood pressure
Временное ограничение: 24 weeks
|
Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.
|
24 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Lilian Cuppari, PhD, Federal University of São Paulo
- Главный следователь: Danilo T Aoike, MSc, Federal University of São Paulo
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
- Gomes TS, Aoike DT, Baria F, Graciolli FG, Moyses RMA, Cuppari L. Effect of Aerobic Exercise on Markers of Bone Metabolism of Overweight and Obese Patients With Chronic Kidney Disease. J Ren Nutr. 2017 Sep;27(5):364-371. doi: 10.1053/j.jrn.2017.04.009. Epub 2017 Jun 9.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 августа 2009 г.
Первичное завершение (Действительный)
1 февраля 2013 г.
Завершение исследования (Действительный)
1 марта 2013 г.
Даты регистрации исследования
Первый отправленный
11 февраля 2015 г.
Впервые представлено, что соответствует критериям контроля качества
4 марта 2015 г.
Первый опубликованный (Оценивать)
5 марта 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
26 марта 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 марта 2015 г.
Последняя проверка
1 марта 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2009/14786-0
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. .