GrandMove Project to Promote Elders' Robustness Against Frailty (NCT05397288) | Clinical Trial Compass
CompletedNot Applicable
GrandMove Project to Promote Elders' Robustness Against Frailty
Hong Kong390 participantsStarted 2015-07-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in physical frailty status measured by the 5-item FRAIL scale 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.