Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multimodal Exercise Programs for Fall Prevention - Psychomotor Versus Psychomotor Combined With Whole-Body Vibration: A Randomized Controlled Trial

Conditions
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Fallers, High Risk of Falling

Intervention / Treatment
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* Other: Psychomotor exercise program
* Other: Combined exercise program


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychomotor exercise program<br>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<br>* 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.<br>|
| Experimental: Combined exercise program<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>Usual care. After the study, control group (CG) participants will be offered the opportunity to integrate a similar fall prevention program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 0,3,6,9 months | 
| Change from Baseline, between and within groups comparison, in Physical Performance | Outcome Measure - Static Posturography Platform to assess balance | 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 | 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 (%) | 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 | 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 | 0,6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg Rating of Perceived Exertion | Exercise intensity | 0-6 months | 
| Mini-Mental State Examination | Cognitive state | 0 months | 
| Composite Physical Function scale | Physical independence | 0 months | 
| International Physical Activity Questionnaire | Physical activity | 0 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Elderly, Psychomotor exercise program, Whole body vibration