Enhancing Physical Reserve to Promote Resilience in Physically Frail Older Adults

Official title

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

Overview

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)?

Detailed description

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.

Interventions

• Behavioral 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
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

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

Identifiers

NCT: NCT07513701 · HSEARS20250709003 · 25603525

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗