Study of the Cognitive and Neurophysiological Effects of the Activ4Brain Program for Older Adults

NCT07108413 | Completed

• 1 other identifier: Activ4Brain
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the cognitive, neuronal, and physical effects of the Activ4Brain program in older men and women between 55 and 75 years of age. The program Activ4Brain consists of 24 sessions of aerobic exercise classes (twice a week over 3 months) that include computerized games designed to train cognition. Participants are tested before and after the 3-months intervention. Researchers will study changes in cognitive function, brain and body physiological activity, and inflammation and neuroprotective markers in 3 groups of participants: the Activ4Brain group that engages in the Activ4Brain program, an active control group that engages in aerobic exercise classes and a passive control group that does not engage in any intervention. This study aims to answer the following questions.

• Does the program Activ4Brain improve cognition in cognitively healthy older adults?
• Does the program Activ4Brain change brain function and body physiology in cognitively healthy older adults?

Conditions

Older People

Keywords

Aerobic exercise; Cognitive training; Age-related cognitive decline; Electroencephalography (EEG); Immune function biomarkers

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Executive Function - Multitasking test from the CANTAB Research Connect

  Executive function will be assessed with the Multitasking test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score change in MTT Multitasking cost (median). The score is calculated by subtracting the median latency of response during single task block(s) from the median latency of response during multitasking block(s). A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information. Lower values are associated with better executive function.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Working Memory - Spatial Working Memory (SWM) test from the CANTAB Research Connect

  Working memory will be assessed with the Spatial Working Memory (SWM) test from the CANTAB Research Connect (Cambridge Cognition Ltd)- 3-months score change in SWM Between Errors: the number of times the subject incorrectly revisits a box in which a token has previously been found. Lower values are associated with better working memory abilities.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Episodic Memory - Auditory Verbal Learning Test

  Auditory Verbal Learning Test (AVLT) - 3-months score change in Total Learning: the sum of words remembered across Trial 1 through Trial 5. Higher values represent better memory abilities.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Sustained Attention - Rapid Visual Information Processing test from the CANTAB Research Connect

  Sustained attention will be assessed with the Rapid Visual Information Processing test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score changes in RVPA (subject's sensitivity to the target sequence). Higher values represent better sustained attention scores.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Processing Speed - Rapid Visual Information Processing test from the CANTAB Research Connect

  Processing speed will be assessed with the Rapid Visual Information Processing test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score change in RVP Median Response Latency (median response latency on correct trials). Lower values represent faster processing speed.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Processing Speed - Multitasking test from the CANTAB Research Connect

  Processing speed will be assessed with the Multitasking test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score change in MTT Incongruency cost (difference between the median response latency on the congruent versus incongruent trials). A lower incongruency cost indicates that the subject processes conflicting information faster.

  From one month before the 3-months intervention up to one month after the end of the intervention.

Secondary Outcomes (15)

• 1. Change from Baseline in the Amplitude of Event-Related Potentials Evoked during a Reinforcement Learning Task

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Amplitude of Pupil Responses during a Reinforcement Learning Task.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in the Amplitude of Task-Related Heart Rate Responses Evoked during a Reinforcement Learning Task.

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Heart Rate Variability during Rest - time domain measures

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Heart Rate Variability during Rest - frequency domain measures

  From one month before the 3-months intervention up to one month after the end of the intervention.

Other Outcomes (4)

• Change from Baseline in Peak Oxygen Consumption (VO2)

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Body Composition

  From one month before the 3-months intervention up to one month after the end of the intervention.

• Change from Baseline in Body Mass Index (BMI)

  From one month before the 3-months intervention up to one month after the end of the intervention.

Study Arms (3)

Activ4Brain Group

EXPERIMENTAL

Participants in this group perform the Activ4Brain program during 3 months

Behavioral: Activ4Brain Program

Aerobic exercise group

ACTIVE COMPARATOR

Participants in this group perform an Aerobic Exercise program during 3 months

Behavioral: Aerobic Exercise Program

Control group

NO INTERVENTION

Participants in this group receive no intervention during the study and are instructed to carry on their daily routines.

Interventions

Activ4Brain Program BEHAVIORAL

The Activ4Brain Program consists of 24 sessions, twice a week for 3 months. Participants engage in 50 min exercise sessions of moderate intensity (60-80% of maximal heart rate) including 5 min warm-up, 40 min aerobic exercises, and 5 min cool-down. The warm-up period includes similar body movements as the main part of the exercise and dynamic stretching while the cool down period consists of static stretching. The main part of the exercise session is divided in four blocks. Each block consists of 5 min aerobic exercises and 5 min of cognitive training. Participants are instructed to keep moving, marching in place, while performing the cognitive training tasks to maintain the increased heart rate. Each group class is composed of four participants with as must as possible a narrow age range given the participants' schedule convenience.

Activ4Brain Group

Aerobic Exercise Program BEHAVIORAL

The Aerobic Exercise Program consists of 24 sessions, twice a week for 3 months. Participants engage in 50 min exercise sessions of moderate intensity (60-80% of maximal heart rate) including 5 min warm-up, 40 min aerobic exercises, and 5 min cool-down. The warm-up period includes similar body movements as the main part of the exercise and dynamic stretching while the cool down period consists of static stretching. The main part of the exercise session consists of a sequence of four different 5 min blocks of aerobic exercise repeated twice. Each block consists of a combination of three different rhythmic movements. Each group class is composed of four participants.

Aerobic exercise group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 55 and 75 years of age

You may not qualify if:

• Presence of contraindications for physical exercise screened with the Physical Activity Readiness Questionnaire (PAR-Q)
• Presence of objective cognitive impairment screened with the Addenbroke's Cognitive Examination - Revised, which also incorporates the Mini Mental State Examination, providing a double score
• Presence of high fall risk screened with the Timed Up and Go test (TUG)
• Presence of severe neurological or psychiatric conditions

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

University of Coimbra

Coimbra, Portugal

Location

Related Links

• social media page of the Activ4Brain program

Study Officials

• Maria J Ribeiro, PhD

  CIBIT-ICNAS, University of Coimbra, Portugal

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 7, 2025
• Study Start: January 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

PT (1)