Enhancing Physical Reserve to Promote Resilience in Physically Frail Older Adults

Официальное название

Enhancing Physical Reserve to Promote Cognitive and Physical Resilience in Physically Frail Older Adults: A 3-Month Randomized Controlled Trial

Обзор

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)?

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.

Вмешательства

• Поведенческое Aerobic and resistance training
  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 ses
• Поведенческое 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 compensatio

Первичные конечные точки

• 30 seconds sit-to-stand test [Срок оценки: Baseline and 3 months]
• Quantification of physical reserve [Срок оценки: Baseline and 3 months]
• Alzheimer's Disease Assessment Scale-Cognitive-13 [Срок оценки: Baseline and 3 months]
• Total hippocampal volume [Срок оценки: Baseline and 3 months]

Вторичные конечные точки (10)

• Trail Making Test [Срок оценки: Baseline and 3 months]
• Resting state functional connectivity [Срок оценки: Baseline and 3 months]
• Education [Срок оценки: Baseline and 3 months]
• Physical Activity Scale for the EAlderly [Срок оценки: Baseline and 3 months]
• Body mass index [Срок оценки: Baseline and 3 months]
• Pictorial Fit-Frail Scale [Срок оценки: Baseline and 3 months]
• Short Physical Performance Battery [Срок оценки: Baseline and 3 months]
• The Montreal Cognitive Assessment [Срок оценки: Baseline and 3 months]
• Functional Comorbidity Index [Срок оценки: Baselin and 3 months]
• Sleep duration [Срок оценки: Baselin and 3 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University, Department of Rehabilitation Sciences — Гонконг

Идентификаторы

NCT: NCT07513701 · HSEARS20250709003 · 25603525

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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