An interventional study of Psychomotor exercise program and Combined exercise program in Fallers and High Risk of Falling, sponsored by University of Évora. Completed at 1 site in Portugal. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by University of Évora · Not applicable, Interventional, and Prevention
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.
Aging is associated with a decline in executive functions, negatively influencing the motor, social and emotional capacities of older adults. (1) These losses will contribute to increase the risk of falling, so much that most falls occur during the performance of a dual-task (DT) (2).
The lack of balance, strength and poor body composition are seen as causes of falls, and should therefore be considered in the prevention programs of these events in older adults. (3-5) A psychomotor exercise program uses the body and movement as mediators, relying on the prevention of cognitive, sensory, perceptive, emotional and affective deterioration, exploring the neuroplasticity. (6,7) Therefore, this sensorimotor and neurocognitive program may prevent falls, but it is important to analyze its real impact in reducing either falls or the risk factors for falls in the older adults. No studies focusing on this subject were found.
The intervention through the whole body vibration (WBV) is referred in the literature as promoting the improvement of balance, mobility and agility, and preventing falls in the older adults.(8,9) WBV will have long-term therapeutic effects promoting the increase of muscle strength and increased bone mineral density. (10) Being two intervention methods with potential good results on falls prevention, it is not known whether there will be additional benefits in an intervention that combines both methods.
Exclusion Criteria:
The experimental group 1 (EG1) intervention comprises a psychomotor program. The program integrates 3 sessions / week of 75 minutes on alternated days. The psychomotor intervention includes exercises promoting simultaneous motor and cognitive stimulation (interval training).
Other: Psychomotor exercise program
The experimental group 2 (EG2) intervention combines the psychomotor program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days.
Other: Combined exercise program
Usual care. After the study, control group (CG) participants will be offered the opportunity to integrate a similar fall prevention program.
Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (40 min), cool-down (10 min), and finishing ritual (5 min). At the initial stage, the activation of different muscle groups will be performed, providing an elevation of the neurophysiological parameters. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation- physical performance (cardiovascular, strength, balance, flexibility, agility and movement accuracy)- alternating with exercises mainly focused on cognitive stimulation- executive functions (planning ability, information processing speed, attention and dual-task performance). At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants share their sensations experienced.
The EG2 intervention combines the psychomotor exercise program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days. The WBV will integrate 3 sessions / week of 6 minutes each, with programed increased exercise time, series, and frequencies throughout the intervention.
Change from Baseline, between and within groups comparison, in Executive Function
Outcome Measure - Trial Making Test (Part A and B) to assess information processing speed
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Executive Function
Outcome Measure - Deary-Liewald Reaction Timed task to assess single and dual-task performance
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Executive Function
Outcome Measure - Timed Up and Go (dual-task version) to assess dual-task performance
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Executive Function
Outcome Measure - The d2 Test of Attention to assess attention
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Physical Performance
Outcome Measure - Biodex (Peak Torque) to assess lower-body strength
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Physical Performance
Outcome Measure - Senior Fitness Test (30-s Chair Stand Test) to assess lower-body strength
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Physical Performance
Outcome Measure - Timed Up and Go (single and dual-task version) to assess agility
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Physical Performance
Outcome Measure - Static Posturography Platform to assess balance
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Physical Performance
Outcome Measure - Fullerton Advanced Balance Scale, ranging from 0 (worst) to 40 (best) points, to assess balance
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Body Composition
Outcome Measure - Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)
Time frame: 0,3,6,9 months
Change from Baseline, between and within groups comparison, in Body Composition
Outcome Measure - Dual-energy X-ray Absorptiometry to assess bone mineral density
Time frame: 0,3,6,9 months
Fall occurrence in the previous 6 months at baseline and at post-intervention
Comparasion of the number of falls between and within groups
Time frame: 0,6 months
Borg Rating of Perceived Exertion
Exercise intensity
Time frame: 0-6 months
Mini-Mental State Examination
Cognitive state
Time frame: 0 months
Composite Physical Function scale
Physical independence
Time frame: 0 months
International Physical Activity Questionnaire
Physical activity
Time frame: 0 months
Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Évora