GrandMove Project to Promote Elders' Robustness Against Frailty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise Coaching Program With Aerobic Exercise and Resistance Exercise for Prefrail and Frail Older Adults

Conditions
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Frail Elderly Syndrome

Intervention / Treatment
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* Behavioral: Resistance exercise (R)
* Behavioral: Aerobic exercise (A)
* Behavioral: Healthy lifestyle education (E)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance-Aerobic-Education (RAE)<br>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) | Behavioral: Resistance exercise (R)<br>* 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<br>Behavioral: Aerobic exercise (A)<br>* 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<br>Behavioral: Healthy lifestyle education (E)<br>* 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<br>|
| Experimental: Aerobic-Resistance-Education (ARE)<br>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) | Behavioral: Resistance exercise (R)<br>* 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<br>Behavioral: Aerobic exercise (A)<br>* 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<br>Behavioral: Healthy lifestyle education (E)<br>* 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<br>|
| Experimental: Education-Resistance-Aerobic (ERA)<br>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) | Behavioral: Resistance exercise (R)<br>* 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<br>Behavioral: Aerobic exercise (A)<br>* 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<br>Behavioral: Healthy lifestyle education (E)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | 4 time points including: baseline, 6 months, 12 months, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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) | 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. | 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. | 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. | 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. | 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. | 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). | 4 time points including: baseline, 6 months, 12 months, 18 months |