Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activ4Brain Group | Experimental | Participants in this group perform the Activ4Brain program during 3 months |
|
| Aerobic exercise group | Active Comparator | Participants in this group perform an Aerobic Exercise program during 3 months |
|
| Control group | No Intervention | Participants in this group receive no intervention during the study and are instructed to carry on their daily routines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Peak Oxygen Consumption (VO2) | Peak oxygen uptake capacity (VO2 peak) measured in mL/min/Kg, with a submaximal incremental cycle ergometry test (Lode- Excalibur, Netherlands), before and after the intervention. Following a warm-up period, participants started the testing phase with an initial load of 50 watts for women and 75 watts for men33. The load is increased by 25 watts at every three-minute intervals. The test continues at 60-70 rpm and is completed once participants achieve 85% of their predicted maximal heart rate, as determined by the Tanaka Formula. |
Inclusion Criteria:
• Men and women between 55 and 75 years of age
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria J Ribeiro, PhD | CIBIT-ICNAS, University of Coimbra, Portugal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Coimbra | Coimbra | Portugal |
Not provided
| Label | URL |
|---|---|
| social media page of the Activ4Brain program | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| 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. | 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. | 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). | 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). | 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 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). | 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). | 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). | 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). | 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). | 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. | 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). | 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. | 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. | 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. | From the end of the intervention up to one month after the intervention. |
| From one month before the 3-months intervention up to one month after the end of the intervention. |
| Change from Baseline in Body Composition | Changes in body composition is measured for total body mass (kg), fat mass (kg), fat free mass (kg) by bioimpedance. | 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) | 3-months change in body mass index: weight and height will be combined to calculate BMI in kg/m^2). | From one month before the 3-months intervention up to one month after the end of the intervention. |
| Change from Baseline in Phase Angle | 3-months change in Phase Angle (°) calculated automatically by the Inbody 770 device (Biospace) with following formula (°) = (reactance/resistance) × (180/π). | From one month before the 3-months intervention up to one month after the end of the intervention. |