Different Exercising Intensities and Frequencies of Exercise on Depressive Mood and Insomnia
17 января 2022 г. обновлено: The University of Hong Kong
Effects of Different Exercising Intensities and Frequencies of Walking Exercise on Depressive Mood and Insomnia in Older Adults
Aerobic exercise intervention for depression was conventionally recommended three times weekly with moderate intensity in previous studies, but little is known about the training effect of aerobic exercise at low frequency and vigorous intensity.
The purpose of this study is to compare the training effect of aerobic exercise at different exercising frequencies and intensities on older adults with comorbid insomnia and depressive symptoms.
In this study, the investigators will investigate two types of aerobic exercise (i.e., vigorous-intensity exercise and moderate-intensity exercise) under different exercising frequencies (i.e., regular exercising pattern and weekend warrior).
Individuals with chronic insomnia and depressive symptoms will be recruited and randomly allocated into 5 groups: 1) attention control group (stretching exercise), 2) moderate intensity exercise performed thrice weekly (MIE×3/wk), 3) moderate intensity exercise performed once weekly (MIE×1/wk), 4) vigorous intensity exercise performed thrice weekly (VIE×3/wk), and 5) vigorous intensity exercise performed once weekly (VIE×1/wk).
Intervention will be maintained for 12 weeks.
Outcome assessments will be conducted at baseline, 6 weeks and 12 weeks after the intervention.
Outcomes including depressive status, chronic insomnia, objective sleep quality and pattern (measured by Actigraphy), subjective sleep quality (measured by Epworth sleepiness scale, insomnia severity index, PSQI), anxiety status (measured by HADS and GAD-7), quality of life (measured by SF-12), attention level (measured by computer attention test), exercise enjoyment (measured by physical activity enjoyment scale), habitual physical activity level (measured by IPAQ), aerobic fitness (measured by metabolic cart), body adiposity (measured by DXA), blood chemistry, adherence, medication usage, and adverse events will be measure in this study.
This proposed study will provide pilot evidence for the benefits, effectiveness, safety, adherence, and sustainability of low-frequency vigorous aerobic exercise.
the investigators expect the low-frequency exercise modality will enhance the practical suitability of aerobic exercise and will provide evidence for weekend warrior aerobic training strategy as a new exercise option in the management of elderly insomnia and depression.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
75
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Hong Kong, Гонконг
- LKS Faculty of Medicine
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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
50 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- borderline abnormal depression with score above 8 out of 21 on Hospital Anxiety and Depression Scale (HADS),
- chronic insomnia according to the fifth edition of the diagnostic and statistical manual of mental disorder (DSM-5),
- Cantonese, Mandarin or English speaking, and 4) age 50 or above. To enhance generalizability, males and females will be recruited.
Exclusion Criteria:
- contraindications to participating in physical exercise;
- regular exercise habit in the past three months (i.e.,>75 minutes of vigorous-intensity exercise weekly or >150 minutes of moderate-intensity exercise weekly);
- any pre-existing medical or physical issues that affect the experimental test and exercise intervention;
- diagnosis with psychosis, schizophrenia or bipolar disorder;
- currently receiving non-medication treatment for depression or insomnia, such as mindfulness training or cognitive behavior therapy;
- shift worker or other commitment that interferes with the regular sleep pattern at night; and
- abnormal heart's electrical activity according to the exercise electrocardiography (ECG) test, such as irregular heartbeat, arrhythmia, and myocardial infarction.
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: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: Attention control
Subjects in this group will receive one session of 75 minutes stretching exercise per week throughout the 12 weeks experimental period
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Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly.
All walking exercise session will be performed on motor-driven treadmill.
Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs).
Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs).
Warm-up and cool-down will be provided before and after the training.
Participants who failed to achieve 80% attendance will be excluded from the study.
All exercise sessions were supervised by qualified athletic coach.
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Активный компаратор: Moderate-intensity walking exercise ×3/wk
Subjects in this group will receive three sessions of 50 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
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Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly.
All walking exercise session will be performed on motor-driven treadmill.
Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs).
Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs).
Warm-up and cool-down will be provided before and after the training.
Participants who failed to achieve 80% attendance will be excluded from the study.
All exercise sessions were supervised by qualified athletic coach.
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Активный компаратор: Moderate-intensity walking exercise ×1/wk
Subjects in this group will receive one session of 150 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
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Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly.
All walking exercise session will be performed on motor-driven treadmill.
Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs).
Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs).
Warm-up and cool-down will be provided before and after the training.
Participants who failed to achieve 80% attendance will be excluded from the study.
All exercise sessions were supervised by qualified athletic coach.
|
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Активный компаратор: Vigorous-intensity walking exercise ×3/wk
Subjects in this group will receive three sessions of 25 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
|
Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly.
All walking exercise session will be performed on motor-driven treadmill.
Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs).
Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs).
Warm-up and cool-down will be provided before and after the training.
Participants who failed to achieve 80% attendance will be excluded from the study.
All exercise sessions were supervised by qualified athletic coach.
|
|
Активный компаратор: Vigorous-intensity walking exercise ×1/wk
Subjects in this group will receive one session of 75 minutes vigorous walking exercise per week throughout the 12 weeks experimental period
|
Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly.
All walking exercise session will be performed on motor-driven treadmill.
Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs).
Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs).
Warm-up and cool-down will be provided before and after the training.
Participants who failed to achieve 80% attendance will be excluded from the study.
All exercise sessions were supervised by qualified athletic coach.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Level of depression
Временное ограничение: After completion of the 12 weeks intervention
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Hospital Anxiety and Depression Scale (HADS) will be used to measure the level of depression
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After completion of the 12 weeks intervention
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Remission rate of insomnia
Временное ограничение: After completion of the 12 weeks intervention
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Brief insomnia questionnaire (BIQ) will be employed to diagnose the chronic insomnia based on the DSM-5 criteria.
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After completion of the 12 weeks intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Subjective sleep data
Временное ограничение: After completion of the 12 weeks intervention
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The Epworth sleepiness scale, insomnia severity index, and Pittsburgh sleep quality index (PSQI) will be used to measure the sleep quality.
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After completion of the 12 weeks intervention
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Objective sleep data
Временное ограничение: After completion of the 12 weeks intervention
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Actigraphy will be used to measure the sleep quality and pattern.
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After completion of the 12 weeks intervention
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Change in dose of Sleep Medication
Временное ограничение: After completion of the 12 weeks intervention
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The dose of sleep medication used by the subjects changes after intervention.
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After completion of the 12 weeks intervention
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7-day Sleep Diary
Временное ограничение: After completion of the 12 weeks intervention
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Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
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After completion of the 12 weeks intervention
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Treatment response rate
Временное ограничение: After completion of the 12 weeks intervention
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The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
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After completion of the 12 weeks intervention
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Body composition
Временное ограничение: After completion of the 12 weeks intervention
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Body lean mass, fat mass, and bone density will be measured by dual-energy X-ray absorptiometry
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After completion of the 12 weeks intervention
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Maximal oxygen consumption
Временное ограничение: After completion of the 12 weeks intervention
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Metabolic cart will measure the maximal oxygen consumption during the maximal exercise test
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After completion of the 12 weeks intervention
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Anxiety level
Временное ограничение: After completion of the 12 weeks intervention
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Anxiety level will be measured by HASD and General Anxiety Disorder-7.
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After completion of the 12 weeks intervention
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Severity of depression
Временное ограничение: After completion of the 12 weeks intervention
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PHQ-9 will be used to examine the severity of depression.
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After completion of the 12 weeks intervention
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Blood chemistry tests
Временное ограничение: After completion of the 12 weeks intervention
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biological markers related to depression and sleep will be measured by enzyme-linked immunosorbent assa
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After completion of the 12 weeks intervention
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Subjectively measured quality of life
Временное ограничение: After completion of the 12 weeks intervention
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Measured by the 12-item Short Form Survey, scores range from 0 to 100, higher scores indicating better physical and mental health functioning
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After completion of the 12 weeks intervention
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Enjoyment of exercise intervention
Временное ограничение: After completion of the 12 weeks intervention
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Physical activity enjoyment scale will be used to test the subject's perception of the exercise, higher scores reflect greater levels of enjoyment
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After completion of the 12 weeks intervention
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Attention level
Временное ограничение: After completion of the 12 weeks intervention
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Computer attention test in PsychoPy v2 software will be employed to measure the attention.
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After completion of the 12 weeks intervention
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Habitual physical activity
Временное ограничение: After completion of the 12 weeks intervention
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Habitual physical activity will be measured by IPAQ
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After completion of the 12 weeks intervention
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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 (Действительный)
31 января 2019 г.
Первичное завершение (Действительный)
30 сентября 2021 г.
Завершение исследования (Действительный)
31 октября 2021 г.
Даты регистрации исследования
Первый отправленный
17 апреля 2020 г.
Впервые представлено, что соответствует критериям контроля качества
17 апреля 2020 г.
Первый опубликованный (Действительный)
21 апреля 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 февраля 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 января 2022 г.
Последняя проверка
1 июля 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DI
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
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. .