Multicomponent Exercise to Prevent Hospitalization-Associated Disability
Spain300 participantsStarted 2025-02-01
Plain-language summary
The study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Eligible hospitalized patients will be randomly assigned to either the intervention or control group using permuted block randomization (block sizes of 8 and 10), with consideration of gender balance.
Data will be collected at four time points: baseline assessment, hospital discharge, 1 month, and 3 months post-discharge.
Inclusion criteria include age ≥75 years and admission to the acute care unit. Exclusion criteria include refusal or inability to provide informed consent, life expectancy \<3 months or terminal illness (oncological or non-oncological), inability to complete follow-up, medical contraindications to exercise, severe neurocognitive impairment (GDS-FAST stage 7), or severe disability (Barthel Index \<35).
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 equal to or greater than 75 years, admitted to the acute care unit for medical conditions.
Exclusion Criteria:
* Explicit refusal expressed verbally or refusal to sign the informed consent by the patient/main caregiver/legal guardian or inability to obtain it.
* Life expectancy of less than 3 months or terminal oncological or non -oncological disease.
* Inability to follow up.
* Inability to participate in a multicomponent exercise program.
* Medical contraindication to exercise.
* Major neurocognitive disorder at moderate to severe stage (GDS - Fast Reisberg 5-7).
* Moderate to severe disability (measured by the Barthel Index (BI \<60)). Expected hospital stay of less than 6 days.
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
Functional status
Timeframe: Through study completion, an average of 3 months