NCT07108413

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

Study Protocol to Investigate the Effect of a Novel Aerobic Exercise Intervention With Integrated Cognitive Training, Active4Brain, on Cognition, Neurophysiology, and Neuroprotective Markers in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Coimbra · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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?

Detailed description

Cognitive training and physical exercise hold the potential to be successful non-pharmacological treatments for age-related cognitive decline and dementia. However, existing interventions show little to no benefit for preventing or delaying cognitive decline, highlighting the need to develop alternative tools. With this in mind, the Activ4Brain program was designed as a non-pharmacological strategy to reduce the impact of age-related cognitive decline. The Activ4Brain program consists of group aerobic exercise classes where computerized games targeting different cognitive domains are applied during the session to potentiate the effect of physical exercise on cognition. This study investigates the impact of this novel program on cognitive and brain function. The primary objective of this study is: • Evaluation of the efficacy of the Activ4Brain program in improving cognition in older people Secondary objectives are: * Evaluation of the impact of the Activ4Brain program on brain and autonomic function and physical health markers * Evaluation of participants' adherence and retention through attendance rates across all intervention sessions and participation trends over time * Evaluation of the feasibility of the Activ4Brain program including its acceptability, accessibility, and usability.

Conditions

• Older People

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2025-08-07
• Last updated: 2025-08-07

Locations

1 site across 1 country: Portugal