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FallersNCT03446352

Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

A study testing Psychomotor exercise program and Combined exercise program in people with Fallers and High Risk of Falling, run by University of Évora at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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". Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Fallers, High Risk of Falling
What is being tested?
Psychomotor exercise program and Combined exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePortugal
Study dates
1 Jan 2018to 28 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Universidade de Évora

    Evora

Other trials in Portugal

About this study

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

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.

Read the 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.

Being tested
Psychomotor exercise program, Combined exercise program
Keywords
Falls, Elderly, Psychomotor exercise program, Whole body vibration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychomotor exercise programOther

    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.

  • Combined exercise programOther

    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.

Study groups in NCT03446352
Study groupRoleWhat they receive
Psychomotor exercise programExperimentalThe 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).
Receives: Other: Psychomotor exercise program
Combined exercise programExperimentalThe 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.
Receives: Other: Combined exercise program
Control GroupNo interventionUsual care. After the study, control group (CG) participants will be offered the opportunity to integrate a similar fall prevention program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0,3,6,9 months

  2. 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

    Measured: 0,3,6,9 months

  3. 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

    Measured: 0,3,6,9 months

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

    Outcome Measure - The d2 Test of Attention to assess attention

    Measured: 0,3,6,9 months

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

    Outcome Measure - Biodex (Peak Torque) to assess lower-body strength

    Measured: 0,3,6,9 months

  6. 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

    Measured: 0,3,6,9 months

  7. 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

    Measured: 0,3,6,9 months

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

    Outcome Measure - Static Posturography Platform to assess balance

    Measured: 0,3,6,9 months

  9. 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

    Measured: 0,3,6,9 months

  10. 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 (%)

    Measured: 0,3,6,9 months

  11. Change from Baseline, between and within groups comparison, in Body Composition

    Outcome Measure - Dual-energy X-ray Absorptiometry to assess bone mineral density

    Measured: 0,3,6,9 months

  12. Fall occurrence in the previous 6 months at baseline and at post-intervention

    Comparasion of the number of falls between and within groups

    Measured: 0,6 months

Secondary outcomes (4)

  1. Borg Rating of Perceived Exertion

    Exercise intensity

    Measured: 0-6 months

  2. Mini-Mental State Examination

    Cognitive state

    Measured: 0 months

  3. Composite Physical Function scale

    Physical independence

    Measured: 0 months

  4. International Physical Activity Questionnaire

    Physical activity

    Measured: 0 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start1 Jan 2018
  3. Primary completion30 Oct 2018
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446352
Sponsor's protocol ID
UEvora
Status last verified
Dec 2021
First submitted
7 Feb 2018
Last updated
16 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.

    PubMed 25773610

  • Lima LC, Ansai JH, Andrade LP, Takahashi AC. The relationship between dual-task and cognitive performance among elderly participants who exercise regularly. Braz J Phys Ther. 2015 Mar-Apr;19(2):159-66. doi: 10.1590/bjpt-rbf.2014.0082. Epub 2015 Apr 27.

    PubMed 25993629

  • Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.

    PubMed 21694556

  • World Health Organization. Falls. [online]. 2016; Avaliable at: http://www.who.int/mediacentre/factsheets/fs344/en/

  • Latorre Roman PA, Garcia-Pinillos F, Huertas Herrador JA, Cozar Barba M, Munoz Jimenez M. Relationship between sex, body composition, gait speed and body satisfaction in elderly people. Nutr Hosp. 2014 Oct 1;30(4):851-7. doi: 10.3305/nh.2014.30.4.7669.

    PubMed 25335673

  • Oliveira V, Carvalho S, Cardoso T. (2015). Quando o envelhecimento acontece. Rio de Janeiro: Wak Editora. Atualidades da Prática Psicomotora. 2015; 217-233.

  • Fernandes, J. A Gerontopsicomotricidade como Práxis Terapêutica de Mediação Corporal. Journal of Aging and Innovation. 2014; 3 (3).

  • Smith DT, Judge S, Malone A, Moynes RC, Conviser J, Skinner JS. Effects of bioDensity Training and Power Plate Whole-Body Vibration on Strength, Balance, and Functional Independence in Older Adults. J Aging Phys Act. 2016 Jan;24(1):139-48. doi: 10.1123/japa.2015-0057. Epub 2015 Jul 23.

    PubMed 26215362

  • Orr R. The effect of whole body vibration exposure on balance and functional mobility in older adults: a systematic review and meta-analysis. Maturitas. 2015 Apr;80(4):342-58. doi: 10.1016/j.maturitas.2014.12.020. Epub 2015 Jan 12.

    PubMed 25631348

  • Rauch F. Vibration therapy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:166-8. doi: 10.1111/j.1469-8749.2009.03418.x.

    PubMed 19740225

  • Rosado H, Bravo J, Raimundo A, Carvalho J, Pereira C. Optimizing Cognitive and Physical Gains in Older Adults: Benefits of a Psychomotor Intervention Program Based on Functional Level. Medicina (Kaunas). 2025 Sep 2;61(9):1584. doi: 10.3390/medicina61091584.

    PubMed 41010975

  • Rosado H, Bravo J, Raimundo A, Carvalho J, Almeida G, Pereira C. Can two multimodal psychomotor exercise programs improve attention, affordance perception, and balance in community dwellings at risk of falling? A randomized controlled trial. BMC Public Health. 2022 Jul 11;21(Suppl 2):2336. doi: 10.1186/s12889-022-13725-5.

    PubMed 35818044

  • Rosado H, Bravo J, Raimundo A, Carvalho J, Marmeleira J, Pereira C. Effects of two 24-week multimodal exercise programs on reaction time, mobility, and dual-task performance in community-dwelling older adults at risk of falling: a randomized controlled trial. BMC Public Health. 2021 Nov 10;21(Suppl 2):408. doi: 10.1186/s12889-021-10448-x.

    PubMed 34758759

Questions about this trial

What is this clinical trial studying?

A study testing Psychomotor exercise program and Combined exercise program in people with Fallers and High Risk of Falling, run by University of Évora at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline, between and within groups comparison, in Executive Function (time frame: 0,3,6,9 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03446352, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.

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