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

NCT07108413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-08-07

No results posted yet for this study

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

Interventions

BEHAVIORAL

Activ4Brain Program

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.

BEHAVIORAL

Aerobic Exercise Program

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.

Sponsors & Collaborators

  • University of Coimbra

    lead OTHER

Principal Investigators

  • Maria J Ribeiro, PhD · CIBIT-ICNAS, University of Coimbra, Portugal

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07108413 on ClinicalTrials.gov