Aktiv i Sør: a Randomized Controlled Trial (AiS)
23 мая 2017 г. обновлено: Monica Klungland Torstveit, University of Agder
The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial
The purpose of this regional parallel-group RCT was to assess the effect of a six-month tailored telephone and email based physical activity intervention on various measures of physical fitness and body composition in a sample of physically inactive adults.
A total of 111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either an intervention group (IG;n=56) or a no-intervention control group (CG;n=55).
The IG received tailored exercise recommendations, every two months by email or mail (print) in addition to motivational follow-ups every second week, alternatively by email and telephone.
Primary outcome measures were various objective measures of musculoskeletal and cardiorespiratory fitness in addition to various measures of body composition, including waist circumference, body mass index and fat percentage, which were assessed pre- and post-intervention.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
111
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 40 лет до 55 лет (Взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
Participants were included in the study if they were
- healthy
- between the ages of 40-55
- residents of the Agder counties in Norway
- classified as physically inactive (not fulfill the recommendations for physical activity given by the Norwegian Directorate of Health
- within stage one to three of the five stages of change in the transtheoretical model stages of change
Exclusion Criteria:
Participants were excluded if they were
- Unhealthy/ill
- younger than 40 years or older than 55 years
- living outside the Agder counties in Norway
- allready fulfilling the national recommendations given by the Norwegian Directorate of Health
- within stage four or five of the five stages of change in the transtheoretical model stages of change
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: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Intervention group - telephone and print exercise intervention
The intervention group (IG) received a total of three intervention packages, one every second month, during the intervention period.
The first intervention package was distributed at intervention start.
The intervention package consisted of a tailored exercise program, national recommendations for physical activity, prompts and reminders.
Additionally the IG received fortnightly supportive motivational contact every two weeks, alternately by telephone og email
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Intervention has previously been described.
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Без вмешательства: Control group
The control group (CG) were encouraged to continue previous lifestyle.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change from Baseline Cardiorespiratory fitness at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Cardiorespiratory fitness was measured by a modified Balke protocol on a treadmill and registered in ml/kg/min
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Muscular endurance of the back extensors at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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The static back extension test recorded muscular endurance of the back extensors as number of seconds the subject managed to endure a static horizontal position, with their lower body supported by a bench (max 240 sec).
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Hand grip strength at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Hand grip strength was registered to the nearest 1 kilogram (kg) using a hydraulic dynamometer
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Neuromotor fitness at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Neuromotor fitness was registered using the one leg standing test where the duration each subject managed to hold a balancing position was recorded in seconds (max 60 seconds).
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Muscular dynamic endurance of and the ability to stabilize the upper body at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Muscular dynamic endurance of and the ability to stabilize the upper body was registered using a modified push-ups test.
The amount of correctly performed repetitions completed in 40 seconds, was recorded in number.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Flexibility of the hamstring musculature at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Flexibility of the hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Flexibility in the shoulder joint at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Flexibility of the shoulder joint was registered to the nearest centimeter, using the back-scratch test.
The mean registered flexibility score of both shoulders was recorded.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Explosive power in the lower extremities at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Explosive power in the lower extremities was recorded to the nearest centimeter, using the vertical jump test.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Body mass index at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Body mass index was calculated using the formula weight/height^2.
Height and weight were measured using a measuring band (meters) and a weight scale (kilograms) respectively.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Waist circumference at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Waist circumference was registered using a measuring band and the mean of two measures was recorded to the nearest half-centimeter.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Fat percentage at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Fat percentage was measured using the bioimpedance machine InBody 720 and using skinfolds.
Both registered body fat percentage.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Change from Baseline Cardiorespiratory fitness at 6 months
Временное ограничение: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Cardiorespiratory fitness was measure by a modified Balke protocol on a treadmill and registered in l/min.
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Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Age
Временное ограничение: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
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Age was assessed by questionaire to the nearest whole year.
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
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Gender
Временное ограничение: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Gender was assessed using a questionnaire and outcome was either Female or male.
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Educational level
Временное ограничение: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Educational level was assessed using a questionnaire as one of four different levels
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This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical activity level
Временное ограничение: This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Physical activity level was assessed using IPAQ- sf as minutes of physical activity per week.
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This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Stage of change
Временное ограничение: This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Stage of change was assessed using a questionnaire as one of five alternatives.
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This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Monica K Torstveit, PhD, University of Agder
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)
1 апреля 2011 г.
Первичное завершение (Действительный)
1 октября 2011 г.
Завершение исследования (Действительный)
1 февраля 2012 г.
Даты регистрации исследования
Первый отправленный
9 марта 2017 г.
Впервые представлено, что соответствует критериям контроля качества
19 мая 2017 г.
Первый опубликованный (Действительный)
23 мая 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
25 мая 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
23 мая 2017 г.
Последняя проверка
1 мая 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- Aktiv i Sør
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Нет
Описание плана IPD
The IPD of the present study will be shared through publications (articles).
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
продукт, произведенный в США и экспортированный из 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. .
Клинические исследования Intervention group - telephone and print exercise intervention
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Florida International UniversityUniversity of Miami; National Center for Complementary and Integrative Health (NCCIH) и другие соавторыРекрутингДепрессивные симптомы | ВИЧСоединенные Штаты
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Duke UniversityNational Institute of Mental Health (NIMH)ЗавершенныйСпектр шизофрении и другие психотические расстройства | Психические расстройства, тяжелыеТанзания
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationЗавершенныйРак легкого, немелкоклеточныйКанада