Frail Elderly Syndrome
Conditions
Brief 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 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.
Interventions
BEHAVIORALResistance 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
BEHAVIORALAerobic 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
BEHAVIORALHealthy 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
Sponsors
Simon K.Y.Lee Foundation
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months. | 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. | 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 physical frailty status measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months. | 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 aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months. | 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. | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality measured by Pittsburgh Sleep Quality Index at baseline, 6 months, 12 months and 18 months. | 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. It has a range of scores from 0 to 21, with higher scores indicating poor sleep quality and lower scores indicating better sleep quality. |
| Change in nutrition status measured by Mini Nutritional Assessment-Short Form at baseline, 6 months, 12 months and 18 months. | 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. 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). |
| Change in depressive symptoms measured by Patient Health Questionnaire - 9 (PHQ-9) at baseline, 6 months, 12 months and 18 months. | 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. 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) |
| Change in extent of mobility measured by the Life Space Questionnaire at baseline, 6 months, 12 months and 18 months. | 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. 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. |
| Change in verbal fluency was measured by the Verbal Fluency Test at baseline, 6 months, 12 months and 18 months. | 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. 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. |
| Change in cognitive performance measured by Digit Symbol Substitution Test at baseline, 6 months, 12 months and 18 months. | 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. 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. |
| Change in logical memory was measured by the Logical Memory Test at baseline, 6 months, 12 months and 18 months. | 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. 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. |
| Change in digit span measured by the Digit Span Test at baseline, 6 months, 12 months and 18 months. | 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. 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. |
| Change in health literacy measured by Chinese Health Literacy for Chronic Care at baseline, 6 months, 12 months and 18 months. | 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. It has a range of scores from 0 to 48, and the cut-off score is 36 (≥ 36 indicates adequate health literacy). |
| Change in handgrip strength measured by the (Jamar® Hand Dynamometer - Plus+ Digital - 200 lb. Capacity) at baseline, 6 months, 12 months and 18 months. | 4 time points including: baseline, 6 months, 12 months, 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. |
| Change in pain severity measured by Face Pain Scale - Revised at baseline, 6 months, 12 months and 18 months. | 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. It has a range of scores from 0 to 10, with 0 representing no pain, 10 representing very much pain. |
| Change in physical activity measured by Physical Activity Scale for the Elderly (PASE) at baseline, 6 months, 12 months and 18 months. | 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. 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. |
| Change in activities of daily living measured by Modified Barthel Index at baseline, 6 months, 12 months and 18 months. | 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. It has a range of scores from 0 to 100, with higher scores indicating independence and lower scores indicating dependence. |
| Change in instrumental activities of daily living measured by Lawton Instrumental Activities of Daily Living at baseline, 6 months, 12 months and 18 months. | 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. It has a range of scores from 0 to 18, with higher scores indicating independence and lower scores indicating dependence. |
| Change in social network measured by Lubben Social Network Scale at baseline, 6 months, 12 months and 18 months. | 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. 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition measured by Dual-energy X-ray absorptiometry (DEXA) scanning at baseline and 6 months (outcome in frail subgroup only). | 2 time points including: baseline, 6 months | Change in body composition measured by Dual-energy X-ray absorptiometry (DEXA) scanning at baseline and 6 months (outcome in frail subgroup only). The test results will be in the form T score (a score of -1 or above is classified as normal; a score between -1.1 and -2.4 is classified as osteopenia (low bone mass); a score of -2.5 and below is defined as osteoporosis). |
| Change in functional muscular fitness measured by 30-second Chair Sit-to-stand Test at baseline and 6 months (outcome in frail subgroup only). | 2 time points including: baseline, 6 months | Change in functional muscular fitness measured by 30-second Chair Sit-to-stand Test at baseline and 6 months (outcome in frail subgroup only). The score is the number of stands a person can complete in 30 seconds, with higher scores indicating better functional muscular fitness and lower scores indicating poor functional muscular fitness. |
| Change in upper and lower body strength measured by 3-repetition Maximum (3-RM) Test using Keiser pneumatic variable-resistance machines at baseline and 6 months (outcome in frail subgroup only). | 2 time points including: baseline, 6 months | Change in upper and lower body strength measured by 3-repetition Maximum (3-RM) Test using Keiser pneumatic variable-resistance machines at baseline and 6 months (outcome in frail subgroup only). The score is defined as the maximum weight a person can lift for 3 repetitions. |
| Change in cardiovascular fitness measured by Ergometers and MedGrapics Ultima CardiO2 Gas Exchange System at baseline and 6 months (outcome in frail subgroup only). | 2 time points including: baseline, 6 months | Change in cardiovascular fitness measured by Ergometers and MedGrapics Ultima CardiO2 Gas Exchange System at baseline and 6 months (outcome in frail subgroup only). |
| Change in balance measured by Multifunctional force-measuring plate at baseline and 6 months (outcome in frail subgroup only). | 2 time points including: baseline, 6 months | Change in balance measured by Multifunctional force-measuring plate at baseline and 6 months (outcome in frail subgroup only). |
| Change in flexibility measured by Sit and Reach Flexibility Test at baseline and 6 months (outcome in frail subgroup only). | 2 time points including: baseline, 6 months | Change in flexibility measured by Sit and Reach Flexibility Test at baseline and 6 months (outcome in frail subgroup only). The score is the recorded distance a person can reach forward by the hand with a seated position. |
Countries
Hong Kong
Outcome results
None listed