Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwell… (NCT06731712) | Clinical Trial Compass
CompletedNot Applicable
Targeted Physical Function Exercises on Frailty and Falls Management in Pre-Frail Community-Dwelling Older Adults
Greece121 participantsStarted 2022-12-15
Plain-language summary
The investigators will conduct a randomized controlled trial to assess the impact of targeted physical function exercises on frailty and falls in community-dwelling adults over 65 years of age. Participants will be randomized to an intervention and a control group to undergo an 18-month assessment.
The hypothesis of this study is to investigate the impact of targeted physical function exercises on managing frailty status and concerns about falling among pre-frail older adults. By implementing individualized intervention programs tailored to improve strength, balance, and mobility, the investigators aim to enhance physical function and reduce the risk of frailty-related adverse health outcomes. The investigators seek to empower pre-frail older adults to proactively manage their health, maintain independence, and improve their quality of life as they age.
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:
* participants aged 65 and over
* classified as pre-frail according to SHARE-Frailty Instrument
* independent of movement and activity
* able to perform Mini-Mental Status Examination (MMSE) score ≥24
Exclusion Criteria:
* severe contraindications for physical exercise
* central nervous system impairments
* inability to speak and understand Greek properly
* a cognitive state that prevents understanding the researcher's instructions
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
Level of Frailty status
Timeframe: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).
2
Concerns about Falling
Timeframe: From baseline (T0), at 6 months (T1), at 12 months (T2), to the end of the intervention at 18 months (T3).