Effects of Function-focused Multicomponent Physical Exercise Program. Interventional Single Group… (NCT04221724) | Clinical Trial Compass
CompletedNot Applicable
Effects of Function-focused Multicomponent Physical Exercise Program. Interventional Single Group Study
Spain207 participantsStarted 2019-01-14
Plain-language summary
The purpose of this research study is to determine whether a physical exercise program in nursing homes will maintain autonomy in activities of daily living, decrease vulnerability and improve physical, psychological and cognitive condition. An individualized and progressive multi-component physical exercise program focused on function has been designed to achieve this objective.
Participant will engage in an exercise program for 6 months in their nursing homes, in two sessions per week of 45-60 minutes
Who can participate
Age range
70 Years – 115 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:
* Aged ≥70years
* Scored ≥50 on the Barthel index
* Scored ≥20 on Mini Examen Cognoscitive test (MEC-35), validated and adapted Spanish version of Mini Mental State Examination
* Be able to stand up from the chair and walk 10 meters with or without one person/technical assistance.
Exclusion Criteria:
* If the participants are clinically unstable under the clinical judgment of the medical professionals of the reference center,
* If the risk of adverse effects is greater than the benefit
* If the participants have severe cognitive or psychiatric disorders.
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
Barthel Index
Timeframe: Changes from baseline to 3rd 6th and 12th month
2
Short Physical Performance Battery
Timeframe: Changes from baseline to 3rd 6th and 12th month
3
Handgrip strength
Timeframe: Changes from baseline to 3rd 6th and 12th month
4
Timed Up and Go Test
Timeframe: Changes from baseline to 3rd 6th and 12th month