Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial

Fallers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446352
• Other study ID #: UEvora
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2021
• Source: University of Évora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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". 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Fallers
• High Risk of Falling

Intervention

Other:
• Psychomotor 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.
• Combined exercise program
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.

Locations

Country	Name	City	State
Portugal	Universidade de Évora	Évora

Sponsors (3)

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

Country where clinical trial is conducted

Portugal, 

References & Publications (10)

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. Review. — View Citation

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

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. — View Citation

Latorre Román PA, García-Pinillos F, Huertas Herrador JA, Cózar Barba M, Muñoz Jiménez 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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from Baseline, between and within groups comparison, in Physical Performance	Outcome Measure - Static Posturography Platform to assess balance	0,3,6,9 months
Primary	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
Primary	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
Primary	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
Primary	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	Borg Rating of Perceived Exertion	Exercise intensity	0-6 months
Secondary	Mini-Mental State Examination	Cognitive state	0 months
Secondary	Composite Physical Function scale	Physical independence	0 months
Secondary	International Physical Activity Questionnaire	Physical activity	0 months