Prevention of Falls and Its Consequences in Elderly People (NCT02617303) | Clinical Trial Compass
UnknownNot Applicable
Prevention of Falls and Its Consequences in Elderly People
Spain402 participantsStarted 2015-09
Plain-language summary
Falls are an important risk factor for fragility fractures. Both are associated with the ageing process and as they rise also increase the risk of mortality, disability and dependency. Interventions to prevent falls have been based on multifactorial approaches but the outcomes have shown little effectiveness. Lately, it is being recommended interventions which foster physical exercise incorporating it to daily life activities. The OTAGO exercise programme is based on easy physical exercises for older adults and has shown cost-effective outcomes for falls prevention and its consequences.
Who can participate
Age range
75 Years – 89 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:
* Patients ≥ 75 to 89 years at baseline assigned to Primary Care Team and living in the community
* Ranking the Folstein Mini Mental State Examination test
* Expectation of permanence in the area at least 18 months.
* Agree to participate in the study by informed consent, after reading the patient information sheet.
Exclusion Criteria:
* Current participation in another trial or institutional program of guided physical activity.
* Patients with who have had a hip and/or knee operation or major injury or any other intervention in the last 6 months.
* Patients with who are unable to follow an aerobic physical activity program. Patients using assisted mobility devices are not excluded.
* Patients in Home Care Programs or Nursing Homes at baseline or during the training phase.
* Terminal or severe cancer cases.
* Patients disabled prior to or during the study period.
* Have not been visited in reference's Health Center in the last two years (displacement / transfer
* Very advanced dementia that not allows to follow the instructions in the exercise program and nurse's instructions. In case of a caregiver who assume the realization of exercise program and the following of tips, it may be included.
* Displaced, will temporarily shifted (\>2months/year) o will definitively shifted patients of Health Center.
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
Reduction of falls measured with a questionnaire from April 2016 to June 2017.
Timeframe: 15 months
Trial details
NCT IDNCT02617303
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina