Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older… (NCT07643064) | Clinical Trial Compass
RecruitingNot Applicable
Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care
Spain200 participantsStarted 2026-05-28
Plain-language summary
Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited.
This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system.
The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.
Who can participate
Age range
70 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:
* Community-dwelling adults aged 70 years or older.
* Ability and willingness to provide written informed consent.
* Medical clearance to participate in low-to-moderate intensity physical exercise.
* Presence of frailty or pre-frailty defined by meeting at least two of the following criteria:
* Functional independence sufficient to participate in the intervention (Barthel Index \>80.
* FRAIL Scale score ≥ 1.
* Short Physical Performance Battery (SPPB) score \< 10.
* Gait speed \< 0.8 m/s.
* Timed Up and Go (TUG) test \> 12 seconds.
* Registered at one of the participating primary care centers.
Exclusion Criteria:
* Absolute contraindications to physical exercise, including recent acute myocardial infarction, unstable angina, severe uncontrolled cardiovascular disease, or severe uncorrected aortic stenosis.
* Severe cognitive impairment preventing comprehension of study procedures or exercise instructions.
* Severe psychiatric disorders interfering with participation.
* Absence of a legally authorized representative when required.
* Severe uncontrolled behavioral disturbances.
* Any acute or chronic medical condition considered by the investigators to make participation unsafe.
Discontinuation Criteria:
* Failure to attend the initial mandatory health education workshop.
* Attendance at fewer than 6 of the 12 scheduled supervised exercise sessions.
* Development of an acute medical condition that results in a temporary or permanent contraindication to …
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 frailty status measured by the FRAIL Scale
Timeframe: Baseline and 12 weeks
2
Change in physical performance measured by the Short Physical Performance Battery (SPPB)