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Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03446352
Enrollment
60
Registered
2018-02-26
Start date
2018-01-01
Completion date
2019-02-28
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallers, High Risk of Falling

Keywords

Falls, Elderly, Psychomotor exercise program, Whole body vibration

Brief 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.

Detailed description

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.

Interventions

OTHERPsychomotor exercise 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.

Sponsors

São João de Deus School of Nursing
CollaboratorUNKNOWN
Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
CollaboratorUNKNOWN
University of Évora
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Fall occurrence in the previous 6 months at baseline and at post-intervention0,6 monthsComparasion of the number of falls between and within groups
Change from Baseline, between and within groups comparison, in Executive Function0,3,6,9 monthsOutcome Measure - Trial Making Test (Part A and B) to assess information processing speed
Change from Baseline, between and within groups comparison, in Physical Performance0,3,6,9 monthsOutcome Measure - Biodex (Peak Torque) to assess lower-body strength
Change from Baseline, between and within groups comparison, in Body Composition0,3,6,9 monthsOutcome Measure - Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)

Secondary

MeasureTime frameDescription
Borg Rating of Perceived Exertion0-6 monthsExercise intensity
Mini-Mental State Examination0 monthsCognitive state
Composite Physical Function scale0 monthsPhysical independence
International Physical Activity Questionnaire0 monthsPhysical activity

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026