Frail Elderly SyndromeGrandMoveNCT05397288
GrandMove Project to Promote Elders' Robustness Against Frailty
A study testing Resistance exercise (R), Aerobic exercise (A) and Healthy lifestyle education (E) in people with Frail Elderly Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program, (2) a 6-month resistance exercise program, versus (3) a 6-month psychoeducation program on healthy lifestyle for improving frailty, physical performance, and quality of life in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Resistance exercise (R), Aerobic exercise (A) and Healthy lifestyle education (E)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- screened as frail or prefrail using cutoff scores of the 5-item FRAIL scale;
- living in the community and planned to reside in the area for the duration of the study;
- gave informed consent to participate in the study
Who cannot join
- heart failure, uncontrolled angina, severe pulmonary disease, or end-stage disease with a life expectancy of less than 18 months
- diagnosed dementia or a cutoff score falling below threshold suggestive of dementia using the clock-face test
- has another member of the household participating in the study
- difficulty in communication with study personnel due to speech or hearing problems
- other medical, psychiatric, or behavioural factors that may interfere with study participation or the ability to follow the intervention protocol
- Temporary Exclusion Criteria:
Show all 11Show fewer
- had stroke, hip fracture, myocardial infarction, major heart surgery, deep vein thrombosis, pulmonary embolus, spinal surgery, or hip or knee replacement within the previous 6 months;
- currently prescribed activity limitation or weight-bearing limitation by a formal healthcare professional;
- limited physical activity due to chest pain or dyspnoea without definitive treatment by a healthcare provider;
- currently consume more than 14 alcoholic drinks per week;
- currently enrolling in another randomized trial involving lifestyle or pharmacological interventions
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong
Hong Kong, Non-US Or Canadian Address
About this study
Official title: Exercise Coaching Program With Aerobic Exercise and Resistance Exercise for Prefrail and Frail Older Adults
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program, (2) a 6-month resistance exercise program, versus (3) a 6-month psychoeducation program on healthy lifestyle for improving frailty, physical performance, and quality of life in frail/prefrail older persons. After 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence.
Read the detailed description
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program led by trained young-old exercise coaches, (2) a 6-month resistance exercise program led by trained young-old exercise coaches, versus (3) a 6-month psychoeducation program on healthy lifestyle led by retired nurses for improving frailty, physical performance, and quality of life in frail/prefrail older persons. A total of 390 frail/prefrail older persons are randomized into one of the three programs in groups of 6 to 10 persons.
After 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence. The sequences are: (a) resistance exercise, aerobic exercise, psychoeducation; (b) aerobic exercise, resistance exercise, psychoeducation; and (c) psychoeducation, resistance exercise, aerobic exercise. The entire intervention period lasts for 18 months.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Resistance exercise (R), Aerobic exercise (A), Healthy lifestyle education (E)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise (R)Behavioural
A 6-month program led by trained young-old exercise coaches consisting of structured training with 5 progressive levels of intensity, with protocols for implementation in a home surrounding and community center settings. During the 6-month program, group practice and home visit (individual) sessions (45 mins each) are delivered in a tapering schedule:
- 1st month: group practice (1 time/week), home visits (2 times/week)
- 2nd month: group practice (1 time/week), home visit (1 time/week), phone call (1 time/week)
- 3rd month: group practice (1 time/week), phone calls (2 times/week)
- 4th month: phone calls (2 times/week)
- 5th month: phone calls (1 time/week)
- 6th month: weaning period
Aerobic exercise (A)Behavioural
A 6-month programs led by trained young-old exercise coaches consisting of structured training with 5 progressive levels of intensity, with protocols for implementation in a home surrounding and community center settings. During the 6-month program, group practice and home visit (individual) (45 mins each) are delivered in a tapering schedule:
- 1st month: group practice (1 time/week), home visits (2 times/week)
- 2nd month: group practice (1 time/week), home visit (1 time/week), phone call (1 time/week)
- 3rd month: group practice (1 time/week), phone calls (2 times/week)
- 4th month: phone calls (2 times/week)
- 5th month: phone calls (1 time/week)
- 6th month: weaning period
Healthy lifestyle education (E)Behavioural
A 6-month program led by retired nurses covering topics including nutrition, sleep, medication, cognition, and exercising. During the 6-month program, group talks and individual consultation (45 mins each) are delivered in a tapering schedule:
- 1st month: group talk (1 time/week), individual consultation (2 times/week)
- 2nd month: group talk (1 time/week), individual consultation (1 time/week), phone call (1 time/week)
- 3rd month: group talk (1 time/week), phone calls (2 times/week)
- 4th month: phone calls (2 times/week)
- 5th month: phone calls (1 time/week)
- 6th month: weaning period
| Study group | Role | What they receive |
|---|---|---|
| Resistance-Aerobic-Education (RAE) | Experimental | Participants first receive 6 months of resistance exercise, then 6 months of aerobic exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) Behavioral: Healthy lifestyle education (E) Receives: Behavioral: Resistance exercise (R); Behavioral: Aerobic exercise (A); Behavioral: Healthy lifestyle education (E) |
| Aerobic-Resistance-Education (ARE) | Experimental | Participants first receive 6 months of aerobic exercise, then 6 months of resistance exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Aerobic exercise (A) Behavioral: Resistance exercise (R) Behavioral: Healthy lifestyle education (E) Receives: Behavioral: Resistance exercise (R); Behavioral: Aerobic exercise (A); Behavioral: Healthy lifestyle education (E) |
| Education-Resistance-Aerobic (ERA) | Experimental | Participants first receive 6 months of education program on healthy lifestyle, then 6 months of resistance exercise, and finally 6 months of aerobic exercise.
Behavioral: Healthy lifestyle education (E) Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) Receives: Behavioral: Resistance exercise (R); Behavioral: Aerobic exercise (A); Behavioral: Healthy lifestyle education (E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical frailty status measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months.
Change in physical frailty status is measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 5, with 0 representing robust health status, 1-2 pre-frail, and 3-5 frail.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months.
Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 12. Higher scores represent better physical performance, lower scores represent poor physical performance.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months.
Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months. Performance is defined by the frequency of arm curls completed in 30 seconds while sitting in a chair. Higher frequencies represent better upper body strength, lower frequencies represent poor upper body strength.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months.
Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months. Performance on the test is defined as the number of right-side steps of the criterion height completed in 2 minutes. Higher frequencies represent better aerobic exercise capacity, lower frequencies represent poor aerobic exercise capacity.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in quality of life measured by World Health Organization Quality of Life - Older Adult Module (WHOQoL-OLD) at baseline, 6 months, 12 months and 18 months.
Change in quality of life measured by World Health Organization Quality of Life - Older Adult Module (WHOQoL-OLD) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 24 to 120. Higher scores indicate better quality of life, lower scores indicate poor quality of life.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months.
Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months. The index is calculated by the sum score divided by the total number of valid responses, ranging from 0 to 1. Frailty status is defined as: robust (FI ≤ 0.08), prefrail (0.08 < FI < 0.25), and frail (FI ≥ 0.25).
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Secondary outcomes (15)
Change in handgrip strength measured by the (Jamar® Hand Dynamometer - Plus+ Digital - 200 lb. Capacity) at baseline, 6 months, 12 months and 18 months.
Change in handgrip strength measured by the (Jamar® Hand Dynamometer - Plus+ Digital - 200 lb. Capacity) at baseline, 6 months, 12 months and 18 months. Performance is defined as the grip force exerted on the dynamometer. Larger forces indicate better handgrip strength, smaller forces indicate poor handgrip strength.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in pain severity measured by Face Pain Scale - Revised at baseline, 6 months, 12 months and 18 months.
Change in pain severity measured by Face Pain Scale - Revised at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 10, with 0 representing no pain, 10 representing very much pain.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical activity measured by Physical Activity Scale for the Elderly (PASE) at baseline, 6 months, 12 months and 18 months.
Change in physical activity measured by Physical Activity Scale for the Elderly (PASE) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 361, with higher scores indicating higher physical activity level and lower scores indicating lower physical activity level.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in activities of daily living measured by Modified Barthel Index at baseline, 6 months, 12 months and 18 months.
Change in activities of daily living measured by Modified Barthel Index at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 100, with higher scores indicating independence and lower scores indicating dependence.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in instrumental activities of daily living measured by Lawton Instrumental Activities of Daily Living at baseline, 6 months, 12 months and 18 months.
Change in instrumental activities of daily living measured by Lawton Instrumental Activities of Daily Living at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 18, with higher scores indicating independence and lower scores indicating dependence.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in social network measured by Lubben Social Network Scale at baseline, 6 months, 12 months and 18 months.
Change in social network measured by Lubben Social Network Scale at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 50 (scores <20 are classified as isolated; 21-25 as high risk for isolation; 26-30 as moderate risk for isolation; ≥ 31 as low risk for isolation).
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in sleep quality measured by Pittsburgh Sleep Quality Index at baseline, 6 months, 12 months and 18 months.
Change in sleep quality measured by Pittsburgh Sleep Quality Index at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 21, with higher scores indicating poor sleep quality and lower scores indicating better sleep quality.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in nutrition status measured by Mini Nutritional Assessment-Short Form at baseline, 6 months, 12 months and 18 months.
Change in nutrition status measured by Mini Nutritional Assessment-Short Form at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 30 (scores of 24-30 are classified as normal nutritional status; 17-23.5 as at risk of malnutrition; <17 as malnourished).
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in depressive symptoms measured by Patient Health Questionnaire - 9 (PHQ-9) at baseline, 6 months, 12 months and 18 months.
Change in depressive symptoms measured by Patient Health Questionnaire - 9 (PHQ-9) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in extent of mobility measured by the Life Space Questionnaire at baseline, 6 months, 12 months and 18 months.
Change in extent of mobility measured by the Life Space Questionnaire at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 9, reflecting the number of zones a person has moved in irrespective of the frequency and independence of these movements.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in verbal fluency was measured by the Verbal Fluency Test at baseline, 6 months, 12 months and 18 months.
Change in verbal fluency was measured by the Verbal Fluency Test at baseline, 6 months, 12 months and 18 months. Performance is defined by the number of items in a category that can be verbally listed in 60 seconds. It has a range of scores from 0 to 20, with higher scores indicating higher verbal fluency and lower scores indicating lower verbal fluency.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in cognitive performance measured by Digit Symbol Substitution Test at baseline, 6 months, 12 months and 18 months.
Change in cognitive performance measured by Digit Symbol Substitution Test at baseline, 6 months, 12 months and 18 months. Performance is defined by the number of correct symbols substitution in 90 seconds. It has a range of scores from 0 to 93, with higher scores indicating better cognitive performance and lower scores indicating poor cognitive performance.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in logical memory was measured by the Logical Memory Test at baseline, 6 months, 12 months and 18 months.
Change in logical memory was measured by the Logical Memory Test at baseline, 6 months, 12 months and 18 months. Performance is defined as the number of correct word items recalled. It has a range of scores from 0 to 23, with higher scores indicating better logical memory and lower scores indicating poor logical memory.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in digit span measured by the Digit Span Test at baseline, 6 months, 12 months and 18 months.
Change in digit span measured by the Digit Span Test at baseline, 6 months, 12 months and 18 months. The sequence and span scores have a range from 0 to 8 for forward subsets, and the sequence and span scores have a range from 0 to 7 for backward subsets. Higher scores indicating better cognitive performance and lower scores indicating poor cognitive performance.
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in health literacy measured by Chinese Health Literacy for Chronic Care at baseline, 6 months, 12 months and 18 months.
Change in health literacy measured by Chinese Health Literacy for Chronic Care at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 48, and the cut-off score is 36 (≥ 36 indicates "adequate health literacy").
Measured: 4 time points including: baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jul 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Simon K.Y.Lee Foundation
- Responsible party
- Principal investigator, Professor Terry Y.S. Lum, The University of Hong Kong
- Investigators
- Terry YS Lum, PhD, Principal investigator, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397288
- Sponsor's protocol ID
- EA1511048
- Acronym
- GrandMove
- Status last verified
- May 2022
- First submitted
- 31 Dec 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Coaching Program With Aerobic Exercise and Resistance Exercise for Prefrail and Frail Older Adults
- ClinicalTrials.gov ID
- NCT05397288
- Acronym / sponsor ID
- GrandMove / EA1511048
- Conditions
- Frail Elderly Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Simon K.Y.Lee Foundation
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program, (2) a 6-month resistance exercise program, versus (3) a 6-month psychoeducation program on healthy lifestyle for improving frailty, physical performance, and quality of life in frail/prefrail older persons. After 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence.
Detailed description
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program led by trained young-old exercise coaches, (2) a 6-month resistance exercise program led by trained young-old exercise coaches, versus (3) a 6-month psychoeducation program on healthy lifestyle led by retired nurses for improving frailty, physical performance, and quality of life in frail/prefrail older persons. A total of 390 frail/prefrail older persons are randomized into one of the three programs in groups of 6 to 10 persons.
After 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence. The sequences are: (a) resistance exercise, aerobic exercise, psychoeducation; (b) aerobic exercise, resistance exercise, psychoeducation; and (c) psychoeducation, resistance exercise, aerobic exercise. The entire intervention period lasts for 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance-Aerobic-Education (RAE) | Experimental | Behavioral: Resistance exercise (R), Behavioral: Aerobic exercise (A), Behavioral: Healthy lifestyle education (E)Participants first receive 6 months of resistance exercise, then 6 months of aerobic exercise, and finally 6 months of education program on healthy lifestyle. Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) Behavioral: Healthy lifestyle education (E) |
| Aerobic-Resistance-Education (ARE) | Experimental | Behavioral: Resistance exercise (R), Behavioral: Aerobic exercise (A), Behavioral: Healthy lifestyle education (E)Participants first receive 6 months of aerobic exercise, then 6 months of resistance exercise, and finally 6 months of education program on healthy lifestyle. Behavioral: Aerobic exercise (A) Behavioral: Resistance exercise (R) Behavioral: Healthy lifestyle education (E) |
| Education-Resistance-Aerobic (ERA) | Experimental | Behavioral: Resistance exercise (R), Behavioral: Aerobic exercise (A), Behavioral: Healthy lifestyle education (E)Participants first receive 6 months of education program on healthy lifestyle, then 6 months of resistance exercise, and finally 6 months of aerobic exercise. Behavioral: Healthy lifestyle education (E) Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- screened as frail or prefrail using cutoff scores of the 5-item FRAIL scale;
- living in the community and planned to reside in the area for the duration of the study;
- gave informed consent to participate in the study
Key exclusion criteria (11 listed)
- heart failure, uncontrolled angina, severe pulmonary disease, or end-stage disease with a life expectancy of less than 18 months
- diagnosed dementia or a cutoff score falling below threshold suggestive of dementia using the clock-face test
- has another member of the household participating in the study
- difficulty in communication with study personnel due to speech or hearing problems
- other medical, psychiatric, or behavioural factors that may interfere with study participation or the ability to follow the intervention protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise (R)A 6-month program led by trained young-old exercise coaches consisting of structured training with 5 progressive levels of intensity, with protocols for implementation in a home surrounding and community center settings. During the 6-month program, group practice and home visit (individual) sessions (45 mins each) are delivered in a tapering schedule: * 1st month: group practice (1 time/week), home visits (2 times/week) * 2nd month: group practice (1 time/week), home visit (1 time/week), phone call (1 time/week) * 3rd month: group practice (1 time/week), phone calls (2 times/week) * 4th month: phone calls (2 times/week) * 5th month: phone calls (1 time/week) * 6th month: weaning period | Behavioural | Aerobic-Resistance-Education (ARE), Education-Resistance-Aerobic (ERA), Resistance-Aerobic-Education (RAE) |
| Aerobic exercise (A)A 6-month programs led by trained young-old exercise coaches consisting of structured training with 5 progressive levels of intensity, with protocols for implementation in a home surrounding and community center settings. During the 6-month program, group practice and home visit (individual) (45 mins each) are delivered in a tapering schedule: * 1st month: group practice (1 time/week), home visits (2 times/week) * 2nd month: group practice (1 time/week), home visit (1 time/week), phone call (1 time/week) * 3rd month: group practice (1 time/week), phone calls (2 times/week) * 4th month: phone calls (2 times/week) * 5th month: phone calls (1 time/week) * 6th month: weaning period | Behavioural | Aerobic-Resistance-Education (ARE), Education-Resistance-Aerobic (ERA), Resistance-Aerobic-Education (RAE) |
| Healthy lifestyle education (E)A 6-month program led by retired nurses covering topics including nutrition, sleep, medication, cognition, and exercising. During the 6-month program, group talks and individual consultation (45 mins each) are delivered in a tapering schedule: * 1st month: group talk (1 time/week), individual consultation (2 times/week) * 2nd month: group talk (1 time/week), individual consultation (1 time/week), phone call (1 time/week) * 3rd month: group talk (1 time/week), phone calls (2 times/week) * 4th month: phone calls (2 times/week) * 5th month: phone calls (1 time/week) * 6th month: weaning period | Behavioural | Aerobic-Resistance-Education (ARE), Education-Resistance-Aerobic (ERA), Resistance-Aerobic-Education (RAE) |
Primary outcome
Change in physical frailty status measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical frailty status is measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 5, with 0 representing robust health status, 1-2 pre-frail, and 3-5 frail.
Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 12. Higher scores represent better physical performance, lower scores represent poor physical performance.
Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months. Performance is defined by the frequency of arm curls completed in 30 seconds while sitting in a chair. Higher frequencies represent better upper body strength, lower frequencies represent poor upper body strength.
Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months. Performance on the test is defined as the number of right-side steps of the criterion height completed in 2 minutes. Higher frequencies represent better aerobic exercise capacity, lower frequencies represent poor aerobic exercise capacity.
Change in quality of life measured by World Health Organization Quality of Life - Older Adult Module (WHOQoL-OLD) at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in quality of life measured by World Health Organization Quality of Life - Older Adult Module (WHOQoL-OLD) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 24 to 120. Higher scores indicate better quality of life, lower scores indicate poor quality of life.
Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months. The index is calculated by the sum score divided by the total number of valid responses, ranging from 0 to 1. Frailty status is defined as: robust (FI ≤ 0.08), prefrail (0.08 < FI < 0.25), and frail (FI ≥ 0.25).
15 secondary outcomes
Change in handgrip strength measured by the (Jamar® Hand Dynamometer - Plus+ Digital - 200 lb. Capacity) at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in pain severity measured by Face Pain Scale - Revised at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical activity measured by Physical Activity Scale for the Elderly (PASE) at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in activities of daily living measured by Modified Barthel Index at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in instrumental activities of daily living measured by Lawton Instrumental Activities of Daily Living at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in social network measured by Lubben Social Network Scale at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in sleep quality measured by Pittsburgh Sleep Quality Index at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in nutrition status measured by Mini Nutritional Assessment-Short Form at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in depressive symptoms measured by Patient Health Questionnaire - 9 (PHQ-9) at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in extent of mobility measured by the Life Space Questionnaire at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in verbal fluency was measured by the Verbal Fluency Test at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in cognitive performance measured by Digit Symbol Substitution Test at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in logical memory was measured by the Logical Memory Test at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in digit span measured by the Digit Span Test at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in health literacy measured by Chinese Health Literacy for Chronic Care at baseline, 6 months, 12 months and 18 months.
Time frame: 4 time points including: baseline, 6 months, 12 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry YS Lum, PhD principal investigator
HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise (R), Aerobic exercise (A) and Healthy lifestyle education (E) in people with Frail Elderly Syndrome, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical frailty status measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months. (time frame: 4 time points including: baseline, 6 months, 12 months, 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.