Older PeopleActiv4BrainNCT07108413
Study of the Cognitive and Neurophysiological Effects of the Activ4Brain Program for Older Adults
A study testing Activ4Brain Program and Aerobic Exercise Program in people with Older People, run by University of Coimbra at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Older People
- What is being tested?
- Activ4Brain Program and Aerobic Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 55 and 75 years of age
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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?
Read the 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
- Being tested
- Activ4Brain Program, Aerobic Exercise Program
- Keywords
- Aerobic exercise, Cognitive training, Age-related cognitive decline, Electroencephalography (EEG), Immune function biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activ4Brain ProgramBehavioural
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.
Aerobic Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Activ4Brain Group | Experimental | Participants in this group perform the Activ4Brain program during 3 months Receives: Behavioral: Activ4Brain Program |
| Aerobic exercise group | Active comparator | Participants in this group perform an Aerobic Exercise program during 3 months Receives: Behavioral: Aerobic Exercise Program |
| Control group | No intervention | Participants in this group receive no intervention during the study and are instructed to carry on their daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From one month before the 3-months intervention up to one month after the end of the intervention.
Secondary outcomes (15)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the end of the intervention up to one month after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ribeiro, University of Coimbra
- Investigators
- Maria J Ribeiro, PhD, Principal investigator, CIBIT-ICNAS, University of Coimbra, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108413
- Sponsor's protocol ID
- Activ4Brain
- Acronym
- Activ4Brain
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07108413
- Acronym / sponsor ID
- Activ4Brain / Activ4Brain
- Conditions
- Older People
- Keywords
- Aerobic exercise, Cognitive training, Age-related cognitive decline, Electroencephalography (EEG), Immune function biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Activ4Brain Group | Experimental | Behavioral: Activ4Brain ProgramParticipants in this group perform the Activ4Brain program during 3 months |
| Aerobic exercise group | Active comparator | Behavioral: Aerobic Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women between 55 and 75 years of age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activ4Brain ProgramThe 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. | Behavioural | Activ4Brain Group |
| Aerobic Exercise ProgramThe 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. | Behavioural | Aerobic exercise group |
Primary outcome
Change from Baseline in Executive Function - Multitasking test from the CANTAB Research Connect
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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.
Change from Baseline in Working Memory - Spatial Working Memory (SWM) test from the CANTAB Research Connect
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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.
Change from Baseline in Episodic Memory - Auditory Verbal Learning Test
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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.
Change from Baseline in Sustained Attention - Rapid Visual Information Processing test from the CANTAB Research Connect
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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.
Change from Baseline in Processing Speed - Rapid Visual Information Processing test from the CANTAB Research Connect
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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.
Change from Baseline in Processing Speed - Multitasking test from the CANTAB Research Connect
Time frame: From one month before the 3-months intervention up to one month after the end of the intervention.
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.
15 secondary outcomes
1. Change from Baseline in the Amplitude of Event-Related Potentials Evoked during a Reinforcement Learning Task
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.
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.
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
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
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 Inflammatory Biomarkers
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
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
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
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
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
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
Time frame: One month after the intervention
Feasibility Outcomes: Retention
Time frame: One month after the intervention
Feasibility Outcomes: Average Group Scores in Acceptability Scale
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)
Time frame: From the end of the intervention up to one month after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- social media page of the Activ4Brain programLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria J Ribeiro, PhD principal investigator
CIBIT-ICNAS, University of Coimbra, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activ4Brain Program and Aerobic Exercise Program in people with Older People, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Executive Function - Multitasking test from the CANTAB Research Connect (time frame: From one month before the 3-months intervention up to one month after the end of the intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.