Enhancing Physical Reserve to Promote Resilience in Physically Frail Older Adults
MRI exercise
2 other identifiers
interventional
224
1 country
1
Brief Summary
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)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2026
CompletedFirst Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
September 25, 2026
September 1, 2026
3 years
March 23, 2026
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
30 seconds sit-to-stand test
Mobility
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
Total hippocampal volume
Total hippocampal volume will be selected to reflect brain structural integrity
Baseline and 3 months
Secondary Outcomes (10)
Trail Making Test
Baseline and 3 months
Resting state functional connectivity
Baseline and 3 months
Education
Baseline and 3 months
Physical Activity Scale for the EAlderly
Baseline and 3 months
Body mass index
Baseline and 3 months
- +5 more secondary outcomes
Study Arms (2)
Aerobic and resistance training
EXPERIMENTALParticipants 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
Usual care
PLACEBO COMPARATORParticipant 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong, Hong Kong, 0000000, Hong Kong
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
March 23, 2026
First Posted
April 7, 2026
Study Start
January 19, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Dec 2028
- Access Criteria
- 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.
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