Clinical trial NCT05397288: GrandMove Project to Promote Elders' Robustness Against Frailty
Official title: Exercise Coaching Program With Aerobic Exercise and Resistance Exercise for Prefrail and Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Simon K.Y.Lee Foundation
First posted: 2022-05-31
Enrollment: 390
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical frailty status measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: 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.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
Secondary outcomes:
measure: Change in handgrip strength measured by the (Jamar® Hand Dynamometer - Plus+ Digital - 200 lb. Capacity) at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in pain severity measured by Face Pain Scale - Revised at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in physical activity measured by Physical Activity Scale for the Elderly (PASE) at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in activities of daily living measured by Modified Barthel Index at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in instrumental activities of daily living measured by Lawton Instrumental Activities of Daily Living at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in social network measured by Lubben Social Network Scale at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in sleep quality measured by Pittsburgh Sleep Quality Index at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in nutrition status measured by Mini Nutritional Assessment-Short Form at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in depressive symptoms measured by Patient Health Questionnaire - 9 (PHQ-9) at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in extent of mobility measured by the Life Space Questionnaire at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in verbal fluency was measured by the Verbal Fluency Test at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in cognitive performance measured by Digit Symbol Substitution Test at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in logical memory was measured by the Logical Memory Test at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in digit span measured by the Digit Span Test at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
measure: Change in health literacy measured by Chinese Health Literacy for Chronic Care at baseline, 6 months, 12 months and 18 months.
timeFrame: 4 time points including: baseline, 6 months, 12 months, 18 months
Other outcomes:
measure: Change in body composition measured by Dual-energy X-ray absorptiometry (DEXA) scanning at baseline and 6 months (outcome in frail subgroup only).
timeFrame: 2 time points including: baseline, 6 months
measure: Change in functional muscular fitness measured by 30-second Chair Sit-to-stand Test at baseline and 6 months (outcome in frail subgroup only).
timeFrame: 2 time points including: baseline, 6 months
measure: 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).
timeFrame: 2 time points including: baseline, 6 months
measure: Change in cardiovascular fitness measured by Ergometers and MedGrapics Ultima CardiO2 Gas Exchange System at baseline and 6 months (outcome in frail subgroup only).
timeFrame: 2 time points including: baseline, 6 months
measure: Change in balance measured by Multifunctional force-measuring plate at baseline and 6 months (outcome in frail subgroup only).
timeFrame: 2 time points including: baseline, 6 months
measure: Change in flexibility measured by Sit and Reach Flexibility Test at baseline and 6 months (outcome in frail subgroup only).
timeFrame: 2 time points including: baseline, 6 months
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
state: Non-US Or Canadian Address
Study officials:
affiliation: HKU
name: Terry YS Lum, PhD
role: PRINCIPAL_INVESTIGATOR
References: