- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07672834
Muscle Function Response to Resistance Band Training in Older Adults With Impaired Muscle Power
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Daniel C Low, Doctor of Philosophy
- Номер телефона: +44 01895 268931
- Электронная почта: Daniel.low@brunel.ac.uk
Места учебы
-
-
-
London, Соединенное Королевство, UB8 3PH
- Рекрутинг
- Department of Sport, Health, and Exercise Sciences
-
Контакт:
- Laura Hills, Doctor of Philosophy
- Номер телефона: +44 (0)1895 267369
- Электронная почта: Laura.hills@brunel.ac.uk
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Participants will be of male or female sex and free from known neurological health conditions (e.g. Peripheral Neuropathy, Parkinson's Disease, Stroke, Migraines, Epilepsy) or musculoskeletal injury.
- low muscle power determined as a score of 8.1 and 9 seconds or more for the completion of the 5 times sit to stand test for males and females respectively
Exclusion Criteria:
- Neurological health condition or musculoskeletal injury at the time of baseline testing
- individuals aged under 50
- individuals who have been told to avoid strenuous physical activity
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Resistance band group, with fitness advice
|
Participants will be given a resistance band and at set of exercises that target the lower extremities and asked to perform these as three sets of 15 repetitions, 2 times a week.
Participants will be undertake a series of functional fitness tests and have their performance evaluated against normative values for their age and sex.
Following this advice will be given with the aim of empowering change in physical activity participation.
|
|
Без вмешательства: Normal life
|
|
|
Экспериментальный: Resistance band without fitness advice
|
Participants will be given a resistance band and at set of exercises that target the lower extremities and asked to perform these as three sets of 15 repetitions, 2 times a week.
|
|
Экспериментальный: Fitness advice
|
Participants will be undertake a series of functional fitness tests and have their performance evaluated against normative values for their age and sex.
Following this advice will be given with the aim of empowering change in physical activity participation.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Five times sit to stand time
Временное ограничение: After 12 weeks
|
Sitting on a chair, participants stand to full leg extension, and then return to a seated position 5 times, and the time taken recorded in seconds.
|
After 12 weeks
|
|
Single leg stand time
Временное ограничение: After 12 weeks
|
This is the length of time, in seconds, an individual can stand on a single leg for as long as possible (up to a maximum of 90 seconds)
|
After 12 weeks
|
|
Timed up and go
Временное ограничение: After 12 weeks
|
This is the time, in seconds, it takes for an individual to stand from a seated position, without using their hands, walk around a cone which is 3 meters away, before returning to the seated position.
|
After 12 weeks
|
|
Postural sway
Временное ограничение: after 12 weeks
|
Using a force plate recording at 100Hz for 30 seconds, 5 eyes open and eyes closed trials will be recorded at baseline and after 12 weeks of resistance band exercises.
Using the Centre of Pressure measurements provided.
Linear (e.g. total sway path length and sway path in the medio-lateral and anterior-posterior directions, measured in meters) and non-linear (fractal dimension, unitless measurement units) postural control measurements will be calculated.
|
after 12 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Muscle power
Временное ограничение: After 12 weeks
|
Using a Biodex dynamometer, 5 practice and 5 trial concentric muscle efforts will be performed with the peak torque (newton meters), time to peak torque (seconds) and peak torque (newton meters) at 0.18 seconds will be recorded.
|
After 12 weeks
|
|
Grip strength
Временное ограничение: After 12 weeks
|
using and hand strength dynamometer, grip strength will be measured as the maximum value of 2 maximal efforts using their dominant hand.
This is measured in kilograms.
|
After 12 weeks
|
|
Fear of falling
Временное ограничение: After 12 weeks
|
Falls efficacy scale - international questionnaire (https://sites.manchester.ac.uk/fes-i).
The total score of questions will be used in the analysis.
|
After 12 weeks
|
|
Self-efficacy for exercise
Временное ограничение: After 12 weeks
|
Self-efficacy for exercise questionnaire (SEE) (https://www.sralab.org/sites/default/files/2017-06/Self-efficacy%20for%20exercise_Website_PDF.pdf). The total score of 9 questions will be used in the analysis. The Scale: Each question is rated from 0 (Not Confident) to 10 (Very Confident). Scoring: Add the numbers for all 9 responses together. Range: Total scores range from 0 to 90. Interpretation: Higher totals indicate a greater level of self-efficacy (stronger belief in your ability to maintain an exercise routine). |
After 12 weeks
|
|
Perceived change in body, balance and power
Временное ограничение: After 12 weeks
|
Using a 15 point Likert Global Rating of Change scale (GRC) to measure perceived change. +7 to +1: Ranging from "A very great deal better" (+7) to "A little better" (+1) 0: No change -1 to -7: Ranging from "A little worse" (-1) to "A very great deal worse" (-7) This scale will be completed for the measurement of perceived change in body, balance and power separately (i.e. there will be a separate scores given for each domain). |
After 12 weeks
|
|
Quality of life
Временное ограничение: 12 weeks
|
The Older People Quality of Life questionnaire (OPQOL) will be completed (https://ilcuk.org.uk/wp-content/uploads/2019/03/OPQOL-full-questionnaire.pdf). Each subsection of the OPQOL will be analysed separately. This is scored on a 5 point scale 1 = very good to 5 = very bad. The scores are reversed so that a higher value suggests better quality of life. In each subsection values are summed. Subsections Live overall = min score is 4 and max score is 20 Health = min score is 4 and max score is 20 Social relationships = min score is 5 and max score is 25 Independence, control over life, freedom = min score is 4 and max score is 20 Home and neighbourhood = min score is 4 and max score is 20 Financial circumstances = min score is 4 and max score is 20 Leisure and activities = min score is 6 and max score is 30 |
12 weeks
|
Соавторы и исследователи
Спонсор
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
Ключевые слова
Другие идентификационные номера исследования
- 51560-A-May/2026- 55297-1
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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. .