Clinical trial NCT04189458: Multimodal Exercise Effect on Brain Dynamics, Cognitive Functioning and Physical Fitness
Official title: The Effect of a Multimodal Exercise Program on Brain Dynamics, Cognitive Functioning and Physical Fitness in Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-dwelling Older Adults
Keywords: Older adults
Multimodal exercise program
Brain dynamics
Cognitive functioning
Physical fitness
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: 2019-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of present study is to analyze the effect of a multimodal exercise program on brain dynamics, cognitive functioning and physical fitness in community-dwelling older adults This experimental study is a controlled trial. Participants will be allocated to two groups: experimental group (who attend the multimodal exercise program) and control group (who maintain usual activity).

The multimodal exercise program will run for 12 weeks (3 sessions / week of 60 minutes).

Participants will be assessed 1) at baseline and at 2) at 12 weeks.

Detailed description: Aging is associated with a decline in cognitive functioning (CF), which influence negatively the motor capacities of older adults (1). Differences on dynamic brain, namely reductions in structural and functional connectivity contribute to cognitive decline. However, efficient communications between brain regions works like a prerequisite for CF (2,3).

Programs targeting cognitive functioning improvement evidenced the importance of the information processing speed (IPS). However, IPS may not be the only factor conditioning the relationship between CF and gait in the older people, especially in locomotive tasks that require attention (4). According to Lezak et al. (5), the performance in each area of CF decreases with aging, and the most significant decline is reported on the performance of complex attentional tasks such as selective or divided attention.

Recent studies focusing cognitive or physical fitness programs, have been shown that dual-task (DT) performance, particularly involving walking while performing a task with cognitive interference, predicts the risk of frailty, disability and mortality in older people (6,7).

According Bahureksa, et al. (8), for balance maintenance is needed to incorporate and decipher the sensorimotor information through CF. On the other hand, exercise programs reported as effective strategies for agility, muscle strength and body composition improvement (9, 10). However, no studies were found focusing the effect and benefits of a multimodal exercise program privileging IPS on brain electrical activity, CF and functional fitness in community-dwelling older adults.

This multimodal exercise program, privileging information processing speed and comprising sensorimotor and neurocognitive exercises, may revert the process of loss and decline on brain dynamics, CF and physical fitness in community-dwelling older adults.

Eligibility criteria: Inclusion Criteria:

* Male or female participants aged ≥65 years;
* Community-dwelling older adults living independently;

Exclusion Criteria:

* Presence of cognitive impairment (Mini-Mental State Examination) (11);
* Presence of motor impairment compromising the program participation;
* Presence of neurological problems or diseases compromising the program participation;

Primary outcomes:
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
measure: Change from Baseline, between and within groups comparison
timeFrame: 0, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Universidade de Évora
Study officials:
affiliation: University of Évora
name: Hugo Rosado, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lezak MD, Howieson DB, Bigler ED, Tranel, D. Neuropsychological assessment. New York: Oxford University Press, 5th Edition; 2012.
citation: Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins, IP. New normative values of Mini-mental State Examination. Sinapse: Sociedade Portuguesa de Neurologia. 2009 Nov; 9(2): 10-16
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: Ferreira LK, Busatto GF. Resting-state functional connectivity in normal brain aging. Neurosci Biobehav Rev. 2013 Mar;37(3):384-400. doi: 10.1016/j.neubiorev.2013.01.017. Epub 2013 Jan 17.
citation: Bennett IJ, Madden DJ. Disconnected aging: cerebral white matter integrity and age-related differences in cognition. Neuroscience. 2014 Sep 12;276:187-205. doi: 10.1016/j.neuroscience.2013.11.026. Epub 2013 Nov 23.
citation: Holtzer R, Mahoney J, Verghese J. Intraindividual variability in executive functions but not speed of processing or conflict resolution predicts performance differences in gait speed in older adults. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):980-6. doi: 10.1093/gerona/glt180. Epub 2013 Nov 27.
citation: Verghese J, Holtzer R, Lipton RB, Wang C. Mobility stress test approach to predicting frailty, disability, and mortality in high-functioning older adults. J Am Geriatr Soc. 2012 Oct;60(10):1901-5. doi: 10.1111/j.1532-5415.2012.04145.x. Epub 2012 Sep 24.
citation: Brustio PR, Magistro D, Zecca M, Rabaglietti E, Liubicich ME. Age-related decrements in dual-task performance: Comparison of different mobility and cognitive tasks. A cross sectional study. PLoS One. 2017 Jul 21;12(7):e0181698. doi: 10.1371/journal.pone.0181698. eCollection 2017.
citation: Bahureksa L, Najafi B, Saleh A, Sabbagh M, Coon D, Mohler MJ, Schwenk M. The Impact of Mild Cognitive Impairment on Gait and Balance: A Systematic Review and Meta-Analysis of Studies Using Instrumented Assessment. Gerontology. 2017;63(1):67-83. doi: 10.1159/000445831. Epub 2016 May 13.
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: 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.