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 range65 Years

SexALL

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;

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

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

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 range65 Years

SexALL

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

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