GrandMove Project to Promote Elders' Robustness Against Frailty

The University of Hong Kong (HKU)

Status: Completed

Conditions: Frail Elderly Syndrome

Treatments: Behavioral: Resistance exercise (R); Behavioral: Aerobic exercise (A); Behavioral: Healthy lifestyle education (E)

Study type: Interventional

Funder types: Other

Identifiers

NCT05397288

EA1511048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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390 participants in 3 patient groups

Resistance-Aerobic-Education (RAE)

Experimental group

Description:

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)

Treatment:

Behavioral: Healthy lifestyle education (E)

Behavioral: Aerobic exercise (A)

Behavioral: Resistance exercise (R)

Aerobic-Resistance-Education (ARE)

Experimental group

Description:

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)

Treatment:

Behavioral: Healthy lifestyle education (E)

Behavioral: Aerobic exercise (A)

Behavioral: Resistance exercise (R)

Education-Resistance-Aerobic (ERA)

Experimental group

Description:

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)

Treatment:

Behavioral: Healthy lifestyle education (E)

Behavioral: Aerobic exercise (A)

Behavioral: Resistance exercise (R)