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Completed

NCT Number: NCT04189458

Multimodal Exercise Effect on Brain Dynamics, Cognitive Functioning and Physical Fitness

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.

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Key information

Conditions

Community-dwelling Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Évora

Evora, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Multimodal exercise program

Other

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).

Primary outcomes

  1. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  2. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  3. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  4. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

    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)

  5. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  6. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  7. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  8. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  9. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  10. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  11. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

  12. Change from Baseline, between and within groups comparison

    Time frame: 0, 3 months

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

Sponsors and collaborators

Lead sponsor

University of Évora

Other

Collaborators

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

Registry information

Official study title

The Effect of a Multimodal Exercise Program on Brain Dynamics, Cognitive Functioning and Physical Fitness in Community-dwelling Older Adults

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Dec 6, 2019
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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