Clinical trial NCT03446352: Multimodal Exercise Programs for Fall Prevention: A Randomized Controlled Trial
Official title: Multimodal Exercise Programs for Fall Prevention - Psychomotor Versus Psychomotor Combined With Whole-Body Vibration: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fallers
High Risk of Falling
Keywords: Falls
Elderly
Psychomotor exercise program
Whole body vibration
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: São João de Deus School of Nursing
name: Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA)
First posted: 2018-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change from Baseline, between and within groups comparison, in Executive Function
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Executive Function
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Executive Function
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Executive Function
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Physical Performance
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Physical Performance
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Physical Performance
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Physical Performance
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Physical Performance
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Body Composition
timeFrame: 0,3,6,9 months
measure: Change from Baseline, between and within groups comparison, in Body Composition
timeFrame: 0,3,6,9 months
measure: Fall occurrence in the previous 6 months at baseline and at post-intervention
timeFrame: 0,6 months
Secondary outcomes:
measure: Borg Rating of Perceived Exertion
timeFrame: 0-6 months
measure: Mini-Mental State Examination
timeFrame: 0 months
measure: Composite Physical Function scale
timeFrame: 0 months
measure: International Physical Activity Questionnaire
timeFrame: 0 months
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Universidade de Évora
Study officials:
References:
citation: 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.
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.
citation: 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.
citation: World Health Organization. Falls. [online]. 2016; Avaliable at: http://www.who.int/mediacentre/factsheets/fs344/en/
citation: 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.
citation: Oliveira V, Carvalho S, Cardoso T. (2015). Quando o envelhecimento acontece. Rio de Janeiro: Wak Editora. Atualidades da Prática Psicomotora. 2015; 217-233.
citation: Fernandes, J. A Gerontopsicomotricidade como Práxis Terapêutica de Mediação Corporal. Journal of Aging and Innovation. 2014; 3 (3).
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.
citation: 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.
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.
citation: 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.
citation: 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.