Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

NCT03446352 | Completed

• 1 other identifier: UEvora
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallers; High Risk of Falling

Keywords

Falls; Elderly; Psychomotor exercise program; Whole body vibration

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Borg Rating of Perceived Exertion

  0-6 months

• Mini-Mental State Examination

  0 months

• Composite Physical Function scale

  0 months

• International Physical Activity Questionnaire

  0 months

Study Arms (3)

Psychomotor exercise program

EXPERIMENTAL

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

Combined exercise program

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Usual care. After the study, control group (CG) participants will be offered the opportunity to integrate a similar fall prevention program.

Interventions

Psychomotor exercise program OTHER

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.

Psychomotor exercise program

Combined exercise program OTHER

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.

Combined exercise program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Évora: lead
• São João de Deus School of Nursing: collaborator
• Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA): collaborator

Study Sites (1)

Universidade de Évora

Evora, Portugal

Location

Related Publications (13)

• 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.

  PMID: 25773610 BACKGROUND

• 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.

  PMID: 25993629 BACKGROUND

• 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.

  PMID: 21694556 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25335673 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26215362 BACKGROUND

• 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.

  PMID: 25631348 BACKGROUND

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

  PMID: 19740225 BACKGROUND

• 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.

  PMID: 41010975 DERIVED

• 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.

  PMID: 35818044 DERIVED

• 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.

  PMID: 34758759 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 26, 2018
• Study Start: January 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: February 28, 2019
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)