Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults (NCT07133581) | Clinical Trial Compass
CompletedNot Applicable
Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults
Spain80 participantsStarted 2025-09-04
Plain-language summary
This multicenter randomized controlled trial aims to evaluate the effectiveness of a playful multicomponent exercise intervention (FEXO - Fun Exercise for Older Adults) on intrinsic capacity, frailty, and functional health in institutionalized older adults aged over 75. The FEXO program combines aerobic, strength, balance, and flexibility training in a recreational format. Participants will be randomized to an experimental group (receiving the 14-week FEXO program) or a wait-list control group (continuing daily routines). After the first intervention phase, the control group will also complete the program. Primary outcomes include improvements in intrinsic capacity domains (cognition, locomotion, vitality, sensory, and psychological), frailty phenotype (Fried criteria), and physical function.
Who can participate
Age range
75 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:
* Age ≥75 years.
* Resident in a long-term care facility (residencia geriátrica) affiliated with the Ballesol group (Levante area: Valencia and Alicante).
* Provide informed consent (or consent by legal representative, if appropriate).
* Functional and/or cognitive status that allows them to participate in basic physical activity and understand and follow basic verbal instructions.
Exclusion Criteria:
* Unstable medical condition or uncontrolled chronic disease.
* Severe cognitive impairment or advanced dementia that prevents comprehension or adherence to the intervention, determined by clinical assessment or MMSE \<15.
* Severe physical disability.
* Active infectious disease or acute condition requiring isolation or rest.
* Participation in another structured physical activity or rehabilitation program during the study period.
* End-of-life situation or terminal illness.
* Any condition that, in the judgment of the research or clinical team, would interfere with participation or data collection.
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
Intrinsic Capacity (IC)
Timeframe: Before and inmediately after the intervention
2
Frailty (Fried's Phenotype)
Timeframe: Before and inmediately after the intervention