GrandMove Project to Promote Elders' Robustness Against Frailty

NCT05397288 | Completed

• 1 other identifier: EA1511048
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• 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 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 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 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 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

Other Outcomes (6)

• 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 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 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

Study Arms (3)

Resistance-Aerobic-Education (RAE)

EXPERIMENTAL

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

Aerobic-Resistance-Education (ARE)

EXPERIMENTAL

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

Education-Resistance-Aerobic (ERA)

EXPERIMENTAL

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

Interventions

Resistance exercise (R) 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-Resistance-Education (ARE); Education-Resistance-Aerobic (ERA); Resistance-Aerobic-Education (RAE)

Aerobic exercise (A) 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

Aerobic-Resistance-Education (ARE); Education-Resistance-Aerobic (ERA); Resistance-Aerobic-Education (RAE)

Healthy lifestyle education (E) 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); Education-Resistance-Aerobic (ERA); Resistance-Aerobic-Education (RAE)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Simon K.Y.Lee Foundation: collaborator

Study Sites (1)

The University of Hong Kong

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

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Terry YS Lum, PhD

  HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: May 31, 2022
• Study Start: July 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)