Frailty at Older Adults
Conditions
Keywords
physical frailty, aerobic exercise, resistance training, magnetic resonance imaging, physical reserve
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)?
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
BEHAVIORALAerobic 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 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.
BEHAVIORALUsual 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 seconds sit-to-stand test | Baseline and 3 months | Mobility |
| Quantification of physical reserve | 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. |
| Alzheimer's Disease Assessment Scale-Cognitive-13 | 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. |
| Total hippocampal volume | Baseline and 3 months | Total hippocampal volume will be selected to reflect brain structural integrity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trail Making Test | 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. |
| Resting state functional connectivity | Baseline and 3 months | Functional MRI will be used to measure resting state functional connectivity |
| Education | Baseline and 3 months | Years of education of participants will be recorded |
| Physical Activity Scale for the EAlderly | Baseline and 3 months | Physical activity will be assessed by the Physical Activity Scale for the Elderly. Higher scores represent better physical activity. |
| Body mass index | Baseline and 3 months | Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²). |
| Pictorial Fit-Frail Scale | 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. |
| Short Physical Performance Battery | 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. |
| The Montreal Cognitive Assessment | 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. |
| Functional Comorbidity Index | 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. |
| Sleep duration | Baselin and 3 months | Sleep duration will be recorded in hours over the last 24 hours and the last 7 days. |
Countries
Hong Kong
Contacts
CONTACTChun Liang HSU, PhD
Outcome results
None listed