CompletedNot Applicable

Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

Portugal60 participantsStarted 2018-01-01

Plain-language summary

The aim of present study is to analyze and compare the effect of two exercise programs - psychomotor exercise program vs exercise combined program (psychomotor + whole body vibration) - on risk factors for falls of community-dwelling older adults who are fallers or are "at high risk of falling". This experimental study is a randomized controlled trial. The program will run for 24 weeks (3 sessions / week of 75 minutes), followed by 12 weeks of follow-up without intervention. Participants of the groups will be assessed 1) at baseline, 2) at 12 weeks, 3) at 24 weeks, and 4) after the follow-up. Participants will be randomly allocated to three groups: experimental group 1 (psychomotor program); experimental group 2 (combined program) and control group.

Who can participate

Age range

65 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: * Male or female participants aged ≥65 years; * Community-dwelling older adults; * Older adults who have fallen in the last 6 months or who are at high risk of falling (scoring ≤25 points on Fullerton Advanced Balance Scale); * Participation agreement; Exclusion Criteria: * Presence of severe cognitive decline (patients with a Mini-Mental State Examination ≤9); * Fracture in one or both lower limbs for less than 4 months; * Diagnosed of health conditions compromising the program participation, such as: severe osteoporosis (T ≤ 2.5, with the occurrence of one or more associated osteoporotic fractures); hip or knee prostheses; incapacitating cardiovascular conditions; epilepsy; cancer or metastases; * Do not wish to participate in the study;

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

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Physical Performance

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Physical Performance

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Physical Performance

Timeframe: 0,3,6,9 months

Trial details

NCT IDNCT03446352

SponsorUniversity of Évora

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-30

View on ClinicalTrials.gov More Fallers trials

Plain-language summary

Who can participate

Age range

65 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.

What they're measuring

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Executive Function

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Physical Performance

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Physical Performance

Timeframe: 0,3,6,9 months

Change from Baseline, between and within groups comparison, in Physical Performance

Timeframe: 0,3,6,9 months