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Укрепление физического резерва для повышения устойчивости у физически ослабленных пожилых людей (MRI exercise)

22 сентября 2026 г. обновлено: HSU Chun Liang, The Hong Kong Polytechnic University

Улучшение физического резерва для повышения когнитивной и физической устойчивости у физически ослабленных пожилых людей: 3-месячное рандомизированное контролируемое исследование

The goal of this clinical trial is to assess the efficacy of combined aerobic and resistance training in enhancing physical reserve in older adults with physical frailty. Investigator contend that enhanced physical reserve will enable preservation of cognitive and physical function. The main questions aims to answer are: (1) Compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)?

Обзор исследования

Подробное описание

Objectives: (1) To compared with usual care (i.e., CON), will 3-month aerobic and resistance training (ATRT) improve physical reserve in older adults with physical frailty? (2) Compared with CON, will ATRT lead to changes in the neural network organization? (3) Will improved physical reserve lead to better maintenance of cognitive and physical functioning in spite of presence of white matter hyperintensities (WMH)? (4) What is the association between exercise, neural network, and physical reserve? Hypotheses: Investigator hypothesize that (1) compared to participants randomly assigned to the CON, participants randomly assigned to the 3-month ATRT will show significantly enhanced physical reserve. (2) compared with participants randomly assigned to CON, participants randomly assigned to ATRT will show reduction in Dorsal Attention Network connectivity. (3) Enhanced physical reserve will moderate the negative association between WMH and Trail Making Test performance, as well as WMH and Short Physical Performance Battery performance. (4) combined aerobic and resistance training will enhance physical reserve via a mediated relationship with reduced Dorsal Attention Network connectivity.

Design and subjects: A randomized controlled trial involving 224 community-dwelling older adults with physical frailty Study instruments: Magnetic resonance imaging Interventions: The designed exercise training will be progressive and moderate in intensity. Participants randomized to the ATRT group will undergo a 3-month (i.e., 13-weeks) four-sessions-per-week, 60-minute-per-session exercise with a 10-minute warm-up, 40-minute of moderate intensity exercise training, and 10-minute cool-down. There will be a total of 52 exercise sessions with a 1:3 research staffs (i.e., instructor and assistants) to study participants ratio. To promote participant safety, investigator will limit each session to 12 study participants. To ensure fidelity of the intervention across time, a detailed manual of procedures for each experimental group will be developed and used for staff training.

Data analysis: All analyses will follow the intent to treat principle. The principle investigator will lead all analyses with support from collaborators on WMH quantification and structural MRI analyses. The intention-to-treat analysis will be conducted with multiple imputation followed by a complete-case analysis. Statistical significance for all analyses will be defined at α < 0.05.

Тип исследования

Интервенционный

Регистрация (Оцененный)

224

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

    • Hong Kong
      • Hong Kong, Hong Kong, Гонконг, 0000000
        • Рекрутинг
        • The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
        • Контакт:

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 60 лет до 90 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. are community-dwelling (i.e., not residing in a nursing home or extended care unit) ;
  2. scored < 9/12 on the SPPB;
  3. scored >18/30 on the MoCA;
  4. are able to walk independently; use of walking aid is acceptable;
  5. are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire Plus33 and confirmed by their physician;
  6. have internet at home; and
  7. are able to provide written informed consent.

Exclusion Criteria:

  1. diagnosed with dementia or stroke;
  2. self-report engaging in strength and balance training exercises > two-times-per-week in the 3 months prior to screening;
  3. unable to understand, speak, and read Cantonese/Chinese/English proficiently; and
  4. contraindications for MRI such as MRI-incompatible implants.

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
Экспериментальный: Aerobic and resistance training

Participants will complete two aerobic training sessions and two resistance training sessions per week for a total of four exercise training sessions each week lasting for 3-month (i.e., 13-weeks). Aerobic exercise intensity will be tracked through heart-rate monitors with an age-specific targeted heart-rate-reserve initially set at 50% and progressively increased by 5% weekly until 70% heart-rate-reserve is reached in Week-5, then it will be sustained for the remainder of the trial. The first four weeks of the resistance training program will emphasize on assisting the study participants in gaining familiarity with proper technique. The intensity of the resistance training stimulus will be set to a weight where the participants can complete two sets of 10-15 repetitions, then progressed from 45% to 85% of predicted 1-repetition-maximum determined at Week-4 using the 8-rep maximum test. The 8-rep maximum test is rrepeated every 4 weeks to ensure the exercise intensity is maintained

The aerobic training sessions will involve standardized sets of stationary training, including on-spot jogging, burpees, aerobic steppers, agility ladders, and non-contact boxing. Each participant will rotate through the stations within the 40-minute training period, with one-minute of rest breaks in-between each station. A 20-point rate-of-perceived exertion will be used to monitor participant status during training with a target rate-of-perceived exertion of 16-17.

The resistance training sessions will involve utilizing free weights and resistance bands to stimulate muscle strength. The set of movements include triceps extension, dumbbell bicep curls, seated overhead dumbbell press, bent-over dumbbell row, wall squats, standing calf raises, wall push-ups.

Плацебо Компаратор: Usual care

Participant Retention and Care: Investigator will implement strategies to promote participant retention by: (1) conducting monthly phone calls by the project assistant to encourage and motivate participants to stay within the study; (2) discussing participant barriers/distress and developing coping/action plans; (3) providing monthly updates in the form of in-person/online/phone sessions; and (4) offering a comprehensive report on cognitive function, mobility, brain MRI, and monetary compensation for their time upon completion of the study.

Investigator will facilitate participant care by recording incidental findings from the MRI and providing clinical assessment data that may be shared with healthcare providers upon request. All personnel on the research team will be trained to detect/assess distress or any possibility of harm and respond appropriately.

Participant Retention and Care: Investigator will implement strategies to promote participant retention by: (1) conducting monthly phone calls by the project assistant to encourage and motivate participants to stay within the study; (2) discussing participant barriers/distress and developing coping/action plans; (3) providing monthly updates in the form of in-person/online/phone sessions; and (4) offering a comprehensive report on cognitive function, mobility, brain MRI, and monetary compensation for their time upon completion of the study.

Investigator will facilitate participant care by recording incidental findings from the MRI and providing clinical assessment data that may be shared with healthcare providers upon request. All personnel on the research team will be trained to detect/assess distress or any possibility of harm and respond appropriately.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
30 seconds sit-to-stand test
Временное ограничение: Baseline and 3 months

Mobility

Baseline and 3 months
Quantification of physical reserve
Временное ограничение: Baseline and 3 months

Physical reserve will be operationally defined as the unexplained residual variance in 30-second Sit-to-Stand Test after accounting for the effects of age, cognitive capacity, and brain structural integrity.

Baseline and 3 months
Alzheimer's Disease Assessment Scale-Cognitive-13
Временное ограничение: Baseline and 3 months

Cognitive capacity will be assessed by the Alzheimer's Disease Assessment Scale-Cognitive-13. It measures memory, language, praxis, attention, and executive function, with scores ranging from 0 to 85; higher scores indicate greater cognitive impairment.

Baseline and 3 months
Total hippocampal volume
Временное ограничение: Baseline and 3 months

Total hippocampal volume will be selected to reflect brain structural integrity

Baseline and 3 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Trail Making Test
Временное ограничение: Baseline and 3 months

The Trail Making Test will comprise Part A and Part B. In Part A, participants are instructed to connect numbers in sequential order (e.g., drawing a line from 1 to 2, 2 to 3, 3 to 4, etc.) while being timed. In Part B, participants are instructed to connect, in order, 25 encircled numbers and letters alternately (e.g., 1-A-2-B-3-C) while being timed. A longer time represents worse executive function.

Baseline and 3 months
Resting state functional connectivity
Временное ограничение: Baseline and 3 months

Functional MRI will be used to measure resting state functional connectivity

Baseline and 3 months
Education
Временное ограничение: Baseline and 3 months

Years of education of participants will be recorded

Baseline and 3 months
Physical Activity Scale for the EAlderly
Временное ограничение: Baseline and 3 months

Physical activity will be assessed by the Physical Activity Scale for the Elderly. Higher scores represent better physical activity.

Baseline and 3 months
Body mass index
Временное ограничение: Baseline and 3 months

Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).

Baseline and 3 months
Pictorial Fit-Frail Scale
Временное ограничение: Baseline and 3 months

Physical frailty will be assessed by the Pictorial Fit-Frail Scale. It involves 14 domains, with scores ranging from 0 to 43; higher scores indicate severely frail.

Baseline and 3 months
Short Physical Performance Battery
Временное ограничение: Baseline and 3 months

Physical frailty will be measured by the Short Physical Performance Battery. It measures balance, walking, and sit to stand, with scores ranging from 0 to 12; higher scores indicate greater mobility.

Baseline and 3 months
The Montreal Cognitive Assessment
Временное ограничение: Baseline and 3 months

General cognitive function will be assessed by the Montreal Cognitive Assessment. It measures memory, language, visuospatial, attention, and abstract reasoning, with scores ranging from 0 to 30; higher scores indicate greater general cognition.

Baseline and 3 months
Functional Comorbidity Index
Временное ограничение: Baselin and 3 months

Total number of comorbid conditions will be assessed through the Functional Comorbidity Index , with a maximum score of 18. A lower score indicates fewer comorbidities.

Baselin and 3 months
Sleep duration
Временное ограничение: Baselin and 3 months

Sleep duration will be recorded in hours over the last 24 hours and the last 7 days.

Baselin and 3 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

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)

19 января 2026 г.

Первичное завершение (Оцененный)

31 декабря 2028 г.

Завершение исследования (Оцененный)

31 марта 2029 г.

Даты регистрации исследования

Первый отправленный

23 марта 2026 г.

Впервые представлено, что соответствует критериям контроля качества

30 марта 2026 г.

Первый опубликованный (Действительный)

7 апреля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

22 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Investigators will create a de-identified dataset to share at the time of publishing the primary results of our trial or within 9 months of database lock, whichever comes first. The data to be shared include but not limited to: de-identified instrument item and total scores of primary and secondary outcomes; de-identified exercise session report data

Сроки обмена IPD

Dec 2028

Критерии совместного доступа к IPD

a commitment to using the data only for research purposes and not to identify an individual participant; a commitment to securing the data using appropriate computer technology; a commitment to destroying or returning the data after analyses are completed; all data sharing requests must be reviewed and approved by the PI.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

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. .

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