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

University of Coimbra

Status: Completed

Conditions: Older People

Treatments: Behavioral: Aerobic Exercise Program; Behavioral: Activ4Brain Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07108413

Activ4Brain

Details and patient eligibility

About

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?

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women between 55 and 75 years of age

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Activ4Brain Group

Experimental group

Description:

Participants in this group perform the Activ4Brain program during 3 months

Treatment:

Behavioral: Activ4Brain Program

Aerobic exercise group

Active Comparator group

Description:

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

Treatment:

Behavioral: Aerobic Exercise Program

Control group

No Intervention group

Description:

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