NCT04189458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

November 27, 2019

Last Update Submit

March 27, 2024

Conditions

Keywords

Older adultsMultimodal exercise programBrain dynamicsCognitive functioningPhysical fitness

Outcome Measures

Primary Outcomes (12)

  • Change from Baseline, between and within groups comparison

    Dynamic Brain Outcome Measure - Electroencephalographic evaluation to assess frequency analyses in the alpha, theta and beta power spectrum

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Cognitive Functioning Outcome Measure - Tower of London test, ranging from 0 (worst) to 36 (best), to assess problem-solving ability (n)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Cognitive Functioning Outcome Measure - Tower of London test to assess planning and execution time (s)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Cognitive Functioning Outcome Measure - Useful Field of View Assessment, ranging from 17 (best) to 500 (worst), to evaluate processing speed, selective and divided attention (ms)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Physical Fitness Outcome Measure - Timed Up and Go test (single and dual-task version) to assess agility and dual-task performance (s)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Physical Fitness Outcome Measure - The Ten Step Test to assess agility (s)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Physical Fitness Outcome Measure - Senior Fitness Test (30-Second Chair Stand) to assess lower body strength (resistance) (n)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Physical Fitness Outcome Measure - Short Physical Performance Battery (Chair Stand Test) to assess lower body strength (power) (n)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Physical Fitness Outcome Measure - Fullerton Advanced Balance Scale (modified version), ranging from 0 (worst) to 16 (best) points, to assess balance

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body fat mass (%)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body lean mass (%)

    0, 3 months

  • Change from Baseline, between and within groups comparison

    Body Composition Outcome Measure - Bioimpedance analyzer (Tanita® MC-780) to assess body water (%)

    0, 3 months

Study Arms (2)

Multimodal exercise program

EXPERIMENTAL

The experimental group intervention will attend the multimodal exercise program. The program integrates 3 sessions / week of 60 minutes on alternated days. The multimodal exercise program includes exercises promoting simultaneous motor and cognitive stimulation.

Other: Multimodal exercise program

Control Group

NO INTERVENTION

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

Interventions

Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (30 min), cool-down (5 min), and finishing ritual (5 min). At the initial stage, the activation of different muscle groups will be performed. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities and will privilege IPS. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation - physical fitness (strength, balance and agility) - alternating with exercises mainly focused on cognitive stimulation - CF (planning ability, solving-problems, IPS, attention and DT performance). At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants sign an attendance sheet regarding the session, including perceived exertion (Borg Scale) and satisfaction (Caregiver Treatment Satisfaction questionnaire).

Multimodal exercise program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de Évora

Evora, Portugal

Location

Related Publications (11)

  • Lezak MD, Howieson DB, Bigler ED, Tranel, D. Neuropsychological assessment. New York: Oxford University Press, 5th Edition; 2012.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Hugo Rosado, MSc

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 6, 2019

Study Start

December 2, 2019

Primary Completion

January 30, 2020

Study Completion

June 30, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations