Enhancing Physical Reserve to Promote Resilience in Physically Frail Older Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorThe Hong Kong Polytechnic University

About this trial

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)?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic and resistance training

    Behavioral

    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.

  • Usual Care

    Behavioral

    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.

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: Aerobic and resistance trainingExperimental treatment 1 intervention
Group B: Usual carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

30 seconds sit-to-stand test

Mobility

Time frame
Baseline and 3 months
2

Quantification of physical reserve

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.

Time frame
Baseline and 3 months
3

Alzheimer's Disease Assessment Scale-Cognitive-13

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.

Time frame
Baseline and 3 months
4

Total hippocampal volume

Total hippocampal volume will be selected to reflect brain structural integrity

Time frame
Baseline and 3 months

Secondary outcomes

1

Trail Making Test

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.

Time frame
Baseline and 3 months
2

Resting state functional connectivity

Functional MRI will be used to measure resting state functional connectivity

Time frame
Baseline and 3 months
3

Education

Years of education of participants will be recorded

Time frame
Baseline and 3 months
4

Physical Activity Scale for the EAlderly

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

Time frame
Baseline and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

University of British Columbia

Collaborator