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?
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
72
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.
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.
University of Coimbra
Coimbra, Portugal
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
1. Change from Baseline in the Amplitude of Event-Related Potentials Evoked during a Reinforcement Learning Task
Change in event-related potentials evoked during a reinforcement learning task are assessed using amplitude (microV) measures of event-related potentials recorded using a 64-channel Neuroscan system (Compumedics EUROPE GmbH) with scalp electrodes placed according to the International 10-20 electrode system (500 Hz sampling rate).
Time frame: 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.
Amplitude of task-related pupil responses during cognitive task performance are assessed using pupil size data obtained with an eye tracking system recorded during a reinforcement learning task. Amplitude of pupil responses are measured in normalized units as percentage of the mean pupil size for each participant.
Time frame: 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.
Task-related heart rate responses that occur during a reinforcement learning task are calculated from the electrocardiogram recorded with bipolar electrodes attached to the participants' chest. Task-related heart rate responses are measured as changes in cardiac interbeat-interval associated with task events.
Time frame: 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
3-month change in Mean RR (ms), SDNN (ms), RMSSD (ms).
Time frame: 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
3-month change in VLF (ms\^2), LF (ms\^2), and HF (ms\^2).
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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Change from Baseline in the Concentration of Blood Plasma Levels of Inflammatory Biomarkers
Changes in concentration of inflammatory blood biomarkers are assessed in blood samples collected from venous blood (15 ml) in a fasting state, in the morning. Plasma samples will be quantified by ELISA for Interleukin (IL)-6 (pg/ml), IL-1β (pg/ml), Tumor Necrosis Factor (TNF)-α (pg/ml), Interferon(IFN) -γ (pg/ml), IL-17, (pg/ml).
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
Change from Baseline in the Concentration of Blood Plasma Levels of Anti-Inflammatory Biomarkers
Changes in concentration of anti-inflammatory biomarkers are assessed in blood samples collected from venous blood (15 ml) in fasting state, in the morning. Plasma samples will be quantified by ELISA (Thermofisher, UK) for IL-1Ra (pg/ml), IL-10 (pg/ml).
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
Change from Baseline in the Concentration of Vascular Endothelial Growth Factor-D (VEGF-D) Blood Serum Levels
Changes in concentration of Vascular Endothelial Growth Factor-D (VEGF-D) are assessed in blood samples collected from venous blood (15 ml) in fasting state, in the morning. Serum samples will be quantified by ELISA for VEGF-D (pg/ml).
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
Change from Baseline in the Concentration of Insulin-Like Growth Factor 1 (IGF-1) Blood Serum Levels
Changes in concentration of Insulin-Like Growth Factor 1 (IGF-1) are assessed in blood samples collected from venous blood (15 ml) in fasting state, in the morning. Serum samples will be quantified by ELISA for IGF-1 (ng/ml).
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
Change from Baseline in the Concentration of Neurotrophic Factors Blood Serum Levels
Changes in concentration of Neurotrophic Factors are assessed in blood samples collected from venous blood (15 ml) in fasting state, in the morning. Serum samples will be quantified by ELISA for Brain-Derived Neurotrophic Factor (BDNF)(ng/ml) and Glial cell line-Derived Neurotrophic Factor (GDNF)(ng/ml).
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
Change from Baseline in the Concentration of Irisin Blood Serum Levels
Changes in concentration of Irisin (pg/ml) are assessed in blood samples collected from venous blood (15 ml) in fasting state, in the morning. Serum samples will be quantified by ELISA.
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
Feasibility Outcomes: Adherence to the Intervention Protocols
Adherence to the intervention protocols is assessed by evaluating the attendance rates (percentage of intervention sessions that were attended per participant).
Time frame: One month after the intervention
Feasibility Outcomes: Retention
Retention is quantified at the end of the study from dropout data: percentage of participants that terminated the intervention and completed the follow-up testing procedures in each group.
Time frame: One month after the intervention
Feasibility Outcomes: Average Group Scores in Acceptability Scale
Program acceptability measured with custom made acceptability scale applied to the Activ4Brain and Aerobic Exercise groups. The scale is composed of 4 items and the responses are recorded on a scale ranging from 1 to 5 where larger values are associated with higher acceptability. The acceptability score is calculated as the average score of the 4 items.
Time frame: From the end of the intervention up to one month after the intervention.
Feasibility Outcomes: Average Group Scores in the System Usability Scale (SUS)
Usability of the Activ4Brain cognitive training system measured with the System Usability Scale (SUS) applied to the Activ4Brain group. SUS is composed of 10 items, each measured on a scale from 1 to 5, and yields a single number representing a composite measure of the overall usability of the system being studied. Each item's score contribution ranges from 0 to 4. For items 1, 3, 5, 7, and 9 the score contribution is the scale position minus 1. For items 2, 4, 6, 8 and 10, the contribution is 5 minus the scale position. The sum of the scores is then multiplied by 2.5 to obtain the overall value of System Usability. SUS scores have a range of 0 to 100.
Time frame: From the end of the intervention up to one month after the intervention.