- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03796234
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Valencia, Испания, 46010
- University of Valencia
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- infarction or angina pectoris.
- At least six months elapsed since the diagnosis of heart disease at the time of the start of the study.
- Be physically and cognitively able to complete the evaluations and the program.
Exclusion Criteria:
- Present another type of cardiac disease different from ischemic heart disease.
- Present any physical or psychiatric condition that prevents the normal performance of the evaluations and the program.
- Mobility problems to attend reassessments.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Dietary and physiotherapy
A multidisciplinary program was developed.
3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated.
In addition, a 3-month high intensity interval training program was developed.
Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
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3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated.
In addition, a 3-month high intensity interval training program was developed.
Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
|
Экспериментальный: Physiotherapy
A 3-month high intensity interval training program was developed.
Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
|
A 3-month high intensity interval training program was developed.
Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Adherence to the mediterranean diet
Временное ограничение: baseline
|
Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet.
Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1.
If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet.
If it is less than 9 points is considered bad adhesion.
The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
|
baseline
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Adherence to the mediterranean diet
Временное ограничение: 3 months
|
Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet.
Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1.
If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet.
If it is less than 9 points is considered bad adhesion.
The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
|
3 months
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Food consumption frequency questonnaire
Временное ограничение: baseline
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Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained.
The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.).
It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
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baseline
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Food consumption frequency questonnaire
Временное ограничение: 3 months
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Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained.
The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.).
It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
|
3 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Временное ограничение: baseline
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Bioimpedanciometer OMRON HBF-500INT
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baseline
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Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Временное ограничение: 3 months
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Bioimpedanciometer OMRON HBF-500INT
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3 months
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Weight (in kilograms)
Временное ограничение: baseline
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Weight (in kilograms)
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baseline
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Weight (in kilograms)
Временное ограничение: 3 months
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Weight (in kilograms)
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3 months
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Body mass index
Временное ограничение: baseline
|
weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
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baseline
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Body mass index
Временное ограничение: 3 months
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weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
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3 months
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Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Временное ограничение: baseline
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Circumferences by using a measuring tape
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baseline
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Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Временное ограничение: 3 months
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Circumferences by using a measuring tape
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3 months
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Triceps fat fold in mm
Временное ограничение: Baseline
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Lipocalibre Holtain
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Baseline
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Triceps fat fold in mm
Временное ограничение: 3 months
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Lipocalibre Holtain
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3 months
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Physical activity
Временное ограничение: baseline
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International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity. The score of the different types of activity is expressed in METS-minutes per week. |
baseline
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Physical activity
Временное ограничение: 3 months
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International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity. The score of the different types of activity is expressed in METS-minutes per week. |
3 months
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Health related quality of life
Временное ограничение: baseline
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Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status.
It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health.
The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires.
The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health.
The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100.
A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
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baseline
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Health related quality of life
Временное ограничение: 3 months
|
Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status.
It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health.
The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires.
The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health.
The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100.
A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
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3 months
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Anxiety
Временное ограничение: baseline
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Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
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baseline
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Anxiety
Временное ограничение: 3 months
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
3 months
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Depression
Временное ограничение: baseline
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
baseline
|
Depression
Временное ограничение: 3 months
|
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient.
Two subsets of 7 items each, on Likert scale 0-3.
For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21.
A higher score means greater anxiety and depression.
For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case".
The internal consistency for the Spanish population is HAD-A α = .83
and HAD-D α = .87
(Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
|
3 months
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Elena Marques-Sule, PT, PhD, University of Valencia
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 147697976792
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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