GrandMove Project to Promote Elders' Robustness Against Frailty

NCT ID: NCT05397288

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2019-01-31

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.

Conditions

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Frail Elderly Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Resistance-Aerobic-Education (RAE)

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)

Group Type EXPERIMENTAL

Resistance exercise (R)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Aerobic-Resistance-Education (ARE)

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)

Group Type EXPERIMENTAL

Resistance exercise (R)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Education-Resistance-Aerobic (ERA)

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)

Group Type EXPERIMENTAL

Resistance exercise (R)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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


* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Simon K.Y.Lee Foundation

UNKNOWN

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Terry Y.S. Lum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry YS Lum, PhD

Role: PRINCIPAL_INVESTIGATOR

HKU

Locations

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The University of Hong Kong

Hong Kong, Non-US Or Canadian Address, Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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EA1511048

Identifier Type: -

Identifier Source: org_study_id