- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07928687
Feasibility Study of an Outdoor Strength Training Program for Older Adults
Development and Implementation of Resistance Training Programs in Community-dwelling Older Adults Using Outdoor Activity Benches: a Feasibility and Pilot Study.
In order to promote healthy ageing and independent living, the World Health Organization recommends older adults to engage in resistance exercise at least twice weekly. However, only a minority of the older population complies with these guidelines, stressing the urgent need to develop comprehensive strategies to implement resistance exercise programs in the community. This PhD project will be performed in close collaboration with IPitup vzw, who developed outdoor activity benches, an accommodating smartphone app with exercise instructions and training courses as a low-cost modality for resistance exercise in the general population. The aim is to build upon these existing structures and develop an optimized, progressive resistance exercise program for community-dwelling older adults, which can be performed in small groups without the need for specialized training experts. The program's feasibility, defined in terms of safety, adherence, usability and acceptability, will be tested.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Prof. Christophe Delecluse
- Номер телефона: +32 16 32 90 76
- Электронная почта: christophe.delecluse@kuleuven.be
Учебное резервное копирование контактов
- Имя: Lien Valepyn
- Номер телефона: +32 488 84 85 97
- Электронная почта: lien.valepyn@kuleuven.be
Места учебы
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Бельгия, 3000
- Рекрутинг
- KU Leuven - Department of Movement Sciences
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Контакт:
- Prof. Christophe Delecluse
- Номер телефона: +32 16 32 90 76
- Электронная почта: christophe.delecluse@kuleuven.be
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Community-dwelling adults
- At least 65 years old
Exclusion Criteria:
- Participation in an interventional study with an investigational medicinal product (IMP) or device
- Systematic engagement in resistance exercise during the past year
- Self-reported, unstable cardiovascular disease, neuromuscular disease, acute infection or fever
- Self-reported, surgery in the past year
- Self-reported injuries that result in the inability to perform study-related tasks
- Inability to understand the test and training procedures because of cognitive problems
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Peer-supported outdoor strength training
Participants take part in a 6-week outdoor strength training program using activity benches and a smartphone application. Training is performed in small groups of six community-dwelling older adults. Within each group, one participant acts as a peer coach and provides practical support and motivation. |
Другой: 6-week outdoor strength training program using activity benches and a smartphone application
2x/week, 35-45min sessions at the outdoor activity bench |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants Experiencing Adverse Events
Временное ограничение: Throughout the 6-week intervention
|
Safety of the intervention, assessed as the number of participants experiencing one or more adverse events related to testing or training sessions during the intervention period. |
Throughout the 6-week intervention
|
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Participant Adherence Rate
Временное ограничение: Throughout the 10-week study period
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Adherence to the intervention, assessed as the proportion of participants who complete the intervention and post-intervention assessments. And assessed as the percentage of scheduled training sessions attended by participants during the 6-week intervention. |
Throughout the 10-week study period
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System Usability Scale (SUS)
Временное ограничение: Post-intervention at week 9
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Usability of the intervention will be assessed using the System Usability Scale (SUS), a 10-item questionnaire yielding a total score ranging from 0 to 5. Five items are positively worded, for which higher response scores indicate greater usability, while five items are negatively worded and are reverse-scored, such that lower response scores indicate greater usability. |
Post-intervention at week 9
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Net Promoter Score (NPS)
Временное ограничение: Post-intervention at week 9
|
Acceptability of the intervention, assessed using the Net Promoter Score (NPS), based on participants' likelihood of recommending the programme to others. Scores range from 0 to 10, with higher scores indicating greater acceptability and willingness to recommend the intervention. |
Post-intervention at week 9
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Participant Acceptability of the Intervention
Временное ограничение: Post-intervention at week 9
|
Acceptability of the intervention, assessed through participant feedback regarding the peer-led delivery model and the appropriateness of training intensity and progression. Responses will be summarized descriptively. |
Post-intervention at week 9
|
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Completion Rate of Data Collection Procedures
Временное ограничение: Over the 10-week study period
|
Feasibility of data collection procedures, assessed as the proportion of planned laboratory-based assessments, questionnaire assessments, and IPitup app-based assessments successfully completed by participants. Higher percentages indicate greater feasibility of the data collection procedures. |
Over the 10-week study period
|
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Change in Lower Limb Muscle Strength and Power
Временное ограничение: Baseline at week 1 and post-intervention at week 9
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Preliminary effects of the intervention on muscle strength and power, assessed as the change in lower limb muscle strength and power from baseline to post-intervention. Muscle strength and power will be measured using the predefined study strength assessment protocol. Higher values indicate greater muscle strength and power. |
Baseline at week 1 and post-intervention at week 9
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Implementation Barriers and Facilitators Identified During Focus Groups
Временное ограничение: Post-intervention at week 10
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Implementation barriers and facilitators will be explored through semi-structured focus groups conducted following the intervention. Audio recordings will be transcribed verbatim and analysed using qualitative thematic analysis. Identified barriers and facilitators will be categorized into themes to inform optimization of a future randomized controlled trial. |
Post-intervention at week 10
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Другие идентификационные номера исследования
- S71971
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .