- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04425057
Effect of a High Intensity Interval Training in Older Adults With Coronary Artery Disease
Обзор исследования
Подробное описание
A study comparing 2 groups: high intensity interval training and control group. Interval training group will perform a two-month physiotherapy program based in exercises, at a high intensity, and stretching of muscles at the end. Intensity will be established based on Borg scale and an effort test.
Control group will not perform any physiotherapy program, but will have usual care with medication.
Several parameters will be evaluated at baseline, 2 months and 6 months: anxiety, depression, functional capacity, blood pressure, lipid profile, physical activity, ecc.
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:
- Diagnosed of coronary artery disease
- Discharged from hospital, less than 2 months
Exclusion Criteria:
- Not able to move by themselves
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Interval training
Physiotherapy program during two months: Interval training at a high intensity, inlcuding a warm-up and a cool-down.
Aerobic exercises, resistance exercises, stretching
|
|
Без вмешательства: Control group
No physiotherapy
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Окружность живота
Временное ограничение: 2 месяца
|
окружность живота в см
|
2 месяца
|
Окружность живота
Временное ограничение: 6 месяцев
|
окружность живота в см
|
6 месяцев
|
Kinesiophobia
Временное ограничение: baseline
|
Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
|
baseline
|
Kinesiophobia
Временное ограничение: 2 months
|
Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
|
2 months
|
Kinesiophobia
Временное ограничение: 6 months
|
Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
|
6 months
|
body mass index
Временное ограничение: baseline
|
body mass index, m/kg2
|
baseline
|
body mass index
Временное ограничение: 2 months
|
body mass index, m/kg2
|
2 months
|
body mass index
Временное ограничение: 6 months
|
body mass index, m/kg2
|
6 months
|
abdominal circumference
Временное ограничение: baseline
|
abdominal circumference in cm
|
baseline
|
body fat
Временное ограничение: baseline
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
baseline
|
body fat
Временное ограничение: 2 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
2 months
|
body fat
Временное ограничение: 6 months
|
Bioimpedanciometer OMRON HBF-500INT body fat in %
|
6 months
|
visceral fat
Временное ограничение: baseline
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
baseline
|
visceral fat
Временное ограничение: 2 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
2 months
|
visceral fat
Временное ограничение: 6 months
|
Bioimpedanciometer OMRON HBF-500INT visceral fat in %
|
6 months
|
muscle mass
Временное ограничение: baseline
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
baseline
|
muscle mass
Временное ограничение: 2 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
2 months
|
muscle mass
Временное ограничение: 6 months
|
Bioimpedanciometer OMRON HBF-500INT muscle mass in %
|
6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
anxiety
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
|
anxiety
Временное ограничение: 2 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).
|
2 months
|
anxiety
Временное ограничение: 6 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).
|
6 months
|
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: 2 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).
|
2 months
|
depression
Временное ограничение: 6 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).
|
6 months
|
physical activity
Временное ограничение: baseline
|
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
|
physical activity
Временное ограничение: 2 months
|
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.
|
2 months
|
physical activity
Временное ограничение: 6 months
|
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.
|
6 months
|
functional capacity
Временное ограничение: baseline
|
Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time. Distance walked were determined on exercise cessation (meters). |
baseline
|
functional capacity
Временное ограничение: 2 months
|
Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time. Distance walked were determined on exercise cessation (meters). |
2 months
|
functional capacity
Временное ограничение: 6 months
|
Incremental shuttle walk test will be used to measure functional capacity. Patients were required to walk along a level 10 m course at a previously determined speed dictated by signals from an audio tape recorder. The walking speed was progressively increased at 1 min intervals, for a total of 12 stages. The test was terminated if the patient was unable to continue at the desired speed or if the patient failed to complete the shuttle course in the allowed time. Distance walked were determined on exercise cessation (meters). |
6 months
|
brachial systolic and diastolic blood pressure
Временное ограничение: baseline
|
systolic and diastolic blood pressure (mmHg)
|
baseline
|
brachial systolic and diastolic blood pressure
Временное ограничение: 2 months
|
systolic and diastolic blood pressure (mmHg)
|
2 months
|
brachial systolic and diastolic blood pressure
Временное ограничение: 6 months
|
systolic and diastolic blood pressure (mmHg)
|
6 months
|
health related quality of life
Временное ограничение: baseline
|
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.
|
baseline
|
health related quality of life
Временное ограничение: 2 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.
|
2 months
|
health related quality of life
Временное ограничение: 6 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.
|
6 months
|
Соавторы и исследователи
Спонсор
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
- 2012/0113
Планирование данных отдельных участников (IPD)
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