Alzheimer DiseaseMINANCT07025070
The Link Between Physical Activity and Brain Health in Healthy Adults
An observational study of Alzheimer Disease and Inactivity, run by Technical University of Madrid at 1 site in Spain.
Trial summary
The goal of this observational study is to investigate the cross-sectional relationship between physical activity and brain health from a multiscale approach (neuropsychology, neuroimaging, peripheral biomarkers and genetics) in former athletes and sedentary individuals. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Inactivity, Preventive Therapy
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Region of Madrid
Who may be able to join
- Group A: ex-athletes and continue to perform regular physical exercise (minimum 3 days/week of moderate-vigorous intensity).
- Group B: sedentary individuals, (i.e., perform <150 min of moderate intensity exercise per week or IPAQ score<600 MET min/week).
- In both groups (A and B) the conditions of physical exercise or sedentary lifestyle must have been maintained for at least 6 months prior to the evaluations.
- Not having a history of neurological or psychiatric disorder or suffering from a serious medical condition
Who cannot join
- Medical conditions that have a high risk of associated cognitive symptoms.
- Severe head injury with loss of consciousness within the previous 5 years.
- Alcoholism (>3 alcoholic drinks per day).
- Chronic use of anxiolytics, neuroleptics, narcotics, anticonvulsants, or sedative hypnotics.
- Hearing or visual impairment that would preclude testing
- History of neurological disease with clinically relevant impact on cognition (e.g. cerebrovascular disease).
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- Incidental structural brain findings with impact on cognitive impairment or survival (e.g., malignant brain tumor).
- Presence of severe systemic disease (e.g., cancer under treatment).
- Consumption of anabolic substances.
- Problems understanding spoken or written Spanish.
- Those with pacemakers or metallic implants that may interfere with the MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physical Activity and Sports Sciences (INEF)
Madrid, Madrid, 28040
About this study
Official title: The Link Between Strength and Endurance Training and Brain Health in Healthy Adults: A Comparative Study of Former Professional Athletes and Sedentary Individuals
The goal of this observational study is to investigate the cross-sectional relationship between physical activity and brain health from a multiscale approach (neuropsychology, neuroimaging, peripheral biomarkers and genetics) in former athletes and sedentary individuals. The main question it aims to answer is:
Do former athletes have better brain structure than sedentary people? Evaluating the differences in neurodegenerative processes between competitive training and sedentary and inactivity.
- Conditions
- Alzheimer Disease, Inactivity, Preventive Therapy
- Keywords
- physical activity
- Medical subject headings
- Alzheimer Disease, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ex-athletes and continue to exercise regularly | Not described | |
| Sedentary individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of brain-derived neurotrophic factor (BDNF) in plasma (pg/mL)
Measured with ELISA kit (e.g., R\&D Systems, Cat. #DY248). Higher BDNF reflects greater neurotrophic support.
Measured: Baseline
Concentration of total tau protein in plasma (pg/mL)
Assayed by high-sensitivity ELISA (e.g., Cusabio, Cat. #CSB-E13913h). Greater tau concentration indicates increased axonal injury or neurodegeneration.
Measured: Baseline
Hippocampal volume measured by high-resolution 3 T T1-weighted MRI (mm³)
Volume extracted with FreeSurfer; Larger values indicate greater hippocampal integrity
Measured: Baseline
Resting-state functional connectivity between primary motor cortex and supplementary motor area measured by 3 T fMRI (Fisher-Z)
Fisher-Z transformed correlation computed with CONN; Higher values indicate stronger connectivity
Measured: Baseline
Digit Span Forward maximum span length (digits)
Attention assessed with Wechsler Adult Intelligence Scale-IV Digit Span Forward subtest; Maximum correctly repeated digit sequence recorded. Higher scores indicate better attention/short-term memory capacity.
Measured: Baseline
Trail Making Test Part A completion time (seconds)
Visual attention and processing speed measured by TMT-A; time to connect 25 numbers in ascending order recorded. Shorter times indicate better performance.
Measured: Baseline
Digit Span Backward maximum span length (digits)
Working memory measured with WAIS-IV Digit Span Backward; Longest correctly repeated backward sequence recorded. Higher scores indicate better working memory.
Measured: Baseline
Trail Making Test Part B completion time (seconds)
Executive function (set-shifting) assessed by TMT-B; Time to alternately connect numbers and letters recorded. Shorter times indicate better executive control.
Measured: Baseline
Verbal fluency (F-A-S) total words in 60 s (count)
Phonemic fluency tested with Controlled Oral Word Association Test (letters F, A, S, 60 s each); total correct words across three letters. Higher counts indicate better executive retrieval fluency.
Measured: Baseline
Stroop Color-Word interference score (seconds)
Inhibition assessed with Golden Stroop test; The count of completions within 45 seconds is recorded. Lower times reflect better inhibitory control.
Measured: Baseline
Montreal Cognitive Assessment (MoCA) total score (0 - 30 points)
10-minute screening of global cognition covering memory, attention, language, visuospatial, and executive domains. Values ≥ 26 are considered normal. Higher scores indicate better cognition.
Measured: Baseline
Number of participants carrying at least one APOE ε4 allele (count of participants)
Genomic DNA isolated from EDTA whole blood; APOE genotyping by TaqMan SNP assays rs429358 and rs7412. Any ε4-containing genotype (ε2/ε4, ε3/ε4, ε4/ε4) classified as "ε4 carrier". Higher counts = higher ε4 prevalence.
Measured: Baseline
Secondary outcomes (20)
Maximal oxygen uptake (VO₂max) measured by CPET with ramp protocol on treadmill (mL·kg-¹·min-¹)
Cardiopulmonary exercise test performed on treadmill using Ramp incremental ramp. Breath-by-breath gas exchange collected via metabolic cart. VO₂max defined as the highest 30-s average during the test; Higher values indicate better cardiorespiratory fitness.
Measured: Baseline
Mean daily minutes of moderate-to-vigorous physical activity measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)
Device worn on non-dominant wrist 24 h/day for 7 consecutive days. Raw data (100 Hz) processed in ActiLife with 10 s epochs; Freedson adult cut-points ≥ 1 952 counts·min-¹ define MVPA. Higher values indicate greater physical activity.
Measured: Baseline
Body mass index (BMI) calculated from weight and stadiometer-measured height (kg/m²)
Height measured to 0.1 cm with height measuring rod. Weight obtained from InBody system. BMI = weight ÷ height². Higher BMI indicates greater overall adiposity.
Measured: Baseline
Peak force of mid-thigh-pull test measured by portable force dynamometer (N)
Participants perform two maximal isometric mid-thigh pulls on calibrated dynamometer with 60 s rest. The higher of two trials recorded as peak force. Greater values indicate stronger lower-limb strength.
Measured: Baseline
Handgrip strength measured by grip dynamometer (kg)
Standing posture, shoulder neutral, elbow extended. Two maximal squeezes per hand with dynamometer; 30 s rest between trials. Best value used for analysis. Higher values reflect greater grip strength.
Measured: Baseline
Timed Up-and-Go (TUG) test completion time (seconds)
Participants stand up from a 45-cm chair, walk 3 m, turn, return, and sit; time recorded by timers. Two trials with 1 min rest; Shorter time retained. Lower times represent better agility.
Measured: Baseline
Balance stability and speed score measured by TANITA force platform (unitless)
Balance and speed assessed on TANITA analyzer in eyes-open seated posture; Stand-up as fast as possible when signaled, repeat 3 times to get an optimal value; Manufacturer's composite stability index automatically computed (range 0-100). One 30-s trial; higher scores denote better balance.
Measured: Baseline
Percentage body fat measured by multifrequency bioimpedance analyzer InBody system (%)
Participants barefoot, InBody 770 provides whole-body fat percentage derived from segmental impedance; Higher values denote greater adiposity.
Measured: Baseline
Skeletal muscle mass measured by multifrequency bioimpedance analyzer InBody system (kg)
Analyzer outputs total skeletal muscle mass. Greater values indicate higher muscularity.
Measured: Baseline
Waist circumference measured by flexible tape at midpoint between lowest rib and iliac crest (cm)
Measured at end-expiration; two readings within 1 cm averaged. Larger values indicate central adiposity.
Measured: Baseline
Hip circumference measured by flexible tape at level of greater trochanters (cm)
Two readings averaged; used with waist girth to compute waist-to-hip ratio.
Measured: Baseline
Serum triglycerides measured by enzymatic colorimetric assay (mg/dL)
Fasting venous blood; triglycerides quantified on chemistry analyzer with glycerol phosphate oxidase method. Higher values indicate greater dyslipidemia risk.
Measured: Baseline
Serum total cholesterol measured by enzymatic colorimetric assay (mg/dL)
Chemistry analyzer; Cholesterol esterase/oxidase method. Higher levels indicate increased cardiovascular risk.
Measured: Baseline
Serum high-density lipoprotein (HDL) cholesterol measured by enzymatic assay (mg/dL)
Selective detergent method. Higher HDL is considered protective.
Measured: Baseline
Serum low-density lipoprotein (LDL) cholesterol calculated by Friedewald formula (mg/dL)
LDL-C = total-C - HDL-C - (triglycerides ÷ 5). Higher LDL indicates greater atherogenic risk.
Measured: Baseline
Serum 25-hydroxyvitamin D concentration measured by chemiluminescent immunoassay (ng/mL)
Serum 25-hydroxyvitamin D concentration measured by chemiluminescent immunoassay (ng/mL)
Measured: Baseline
Mean daily sedentary time measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)
Sedentary time defined as < 100 counts·min-¹ in vector-magnitudes; summed across valid waking wear days (≥ 10 h/day). Larger values denote more sedentary lifestyle.
Measured: Baseline
Mean nightly sleep duration measured by ActiGraph wGT3X-BT over 7 nights (hours/night)
Sleep/wake scored with Cole-Kripke algorithm; average total sleep time across nights with ≥ 160 min valid sleep. Longer duration indicates better sleep quantity.
Measured: Baseline
Total physical activity measured by International Physical Activity Questionnaire - Long Form (MET·min/week)
Four IPAQ domains are summed; for each activity, minutes are multiplied by the corresponding MET value and then summed. Higher values indicate greater total energy expenditure.
Measured: Baseline
Mediterranean Diet Adherence Score measured by 14-item Mediterranean Diet Adherence Screener (0 - 14 points)
Each of the 14 items is scored 0 or 1 and summed (total 0-14). A score ≥ 9 is considered high adherence. Higher scores indicate greater adherence to the Mediterranean dietary pattern.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start25 Nov 2024
- Primary completionJan 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songxin Tang, Technical University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025070
- Sponsor's protocol ID
- MINAEPSLRE-MMGG-DATOS-20240219
- Other IDs
- S2022/BMD-7236
- Acronym
- MINA
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, the investigators have not yet decided whether our IPD will be shared. Data sharing policies and procedures are still under discussion within our research group and institution. Further consideration will be given to ethical requirements, participant privacy, and potential future analyses before making a final decision.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between Strength and Endurance Training and Brain Health in Healthy Adults: A Comparative Study of Former Professional Athletes and Sedentary Individuals
- ClinicalTrials.gov ID
- NCT07025070
- Acronym / sponsor ID
- MINA / MINAEPSLRE-MMGG-DATOS-20240219
- Conditions
- Alzheimer Disease, Inactivity, Preventive Therapy
- Keywords
- physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jun 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.
The goal of this observational study is to investigate the cross-sectional relationship between physical activity and brain health from a multiscale approach (neuropsychology, neuroimaging, peripheral biomarkers and genetics) in former athletes and sedentary individuals. The main question it aims to answer is:
Do former athletes have better brain structure than sedentary people? Evaluating the differences in neurodegenerative processes between competitive training and sedentary and inactivity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ex-athletes and continue to exercise regularly | – | – |
| Sedentary individuals | – | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Region of Madrid
Key inclusion criteria (4 listed)
- Group A: ex-athletes and continue to perform regular physical exercise (minimum 3 days/week of moderate-vigorous intensity).
- Group B: sedentary individuals, (i.e., perform <150 min of moderate intensity exercise per week or IPAQ score<600 MET min/week).
- In both groups (A and B) the conditions of physical exercise or sedentary lifestyle must have been maintained for at least 6 months prior to the evaluations.
- Not having a history of neurological or psychiatric disorder or suffering from a serious medical condition
Key exclusion criteria (11 listed)
- Medical conditions that have a high risk of associated cognitive symptoms.
- Severe head injury with loss of consciousness within the previous 5 years.
- Alcoholism (>3 alcoholic drinks per day).
- Chronic use of anxiolytics, neuroleptics, narcotics, anticonvulsants, or sedative hypnotics.
- Hearing or visual impairment that would preclude testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of brain-derived neurotrophic factor (BDNF) in plasma (pg/mL)
Time frame: Baseline
Measured with ELISA kit (e.g., R\&D Systems, Cat. #DY248). Higher BDNF reflects greater neurotrophic support.
Concentration of total tau protein in plasma (pg/mL)
Time frame: Baseline
Assayed by high-sensitivity ELISA (e.g., Cusabio, Cat. #CSB-E13913h). Greater tau concentration indicates increased axonal injury or neurodegeneration.
Hippocampal volume measured by high-resolution 3 T T1-weighted MRI (mm³)
Time frame: Baseline
Volume extracted with FreeSurfer; Larger values indicate greater hippocampal integrity
Resting-state functional connectivity between primary motor cortex and supplementary motor area measured by 3 T fMRI (Fisher-Z)
Time frame: Baseline
Fisher-Z transformed correlation computed with CONN; Higher values indicate stronger connectivity
Digit Span Forward maximum span length (digits)
Time frame: Baseline
Attention assessed with Wechsler Adult Intelligence Scale-IV Digit Span Forward subtest; Maximum correctly repeated digit sequence recorded. Higher scores indicate better attention/short-term memory capacity.
Trail Making Test Part A completion time (seconds)
Time frame: Baseline
Visual attention and processing speed measured by TMT-A; time to connect 25 numbers in ascending order recorded. Shorter times indicate better performance.
Digit Span Backward maximum span length (digits)
Time frame: Baseline
Working memory measured with WAIS-IV Digit Span Backward; Longest correctly repeated backward sequence recorded. Higher scores indicate better working memory.
Trail Making Test Part B completion time (seconds)
Time frame: Baseline
Executive function (set-shifting) assessed by TMT-B; Time to alternately connect numbers and letters recorded. Shorter times indicate better executive control.
Verbal fluency (F-A-S) total words in 60 s (count)
Time frame: Baseline
Phonemic fluency tested with Controlled Oral Word Association Test (letters F, A, S, 60 s each); total correct words across three letters. Higher counts indicate better executive retrieval fluency.
Stroop Color-Word interference score (seconds)
Time frame: Baseline
Inhibition assessed with Golden Stroop test; The count of completions within 45 seconds is recorded. Lower times reflect better inhibitory control.
Montreal Cognitive Assessment (MoCA) total score (0 - 30 points)
Time frame: Baseline
10-minute screening of global cognition covering memory, attention, language, visuospatial, and executive domains. Values ≥ 26 are considered normal. Higher scores indicate better cognition.
Number of participants carrying at least one APOE ε4 allele (count of participants)
Time frame: Baseline
Genomic DNA isolated from EDTA whole blood; APOE genotyping by TaqMan SNP assays rs429358 and rs7412. Any ε4-containing genotype (ε2/ε4, ε3/ε4, ε4/ε4) classified as "ε4 carrier". Higher counts = higher ε4 prevalence.
20 secondary outcomes
Maximal oxygen uptake (VO₂max) measured by CPET with ramp protocol on treadmill (mL·kg-¹·min-¹)
Time frame: Baseline
Mean daily minutes of moderate-to-vigorous physical activity measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)
Time frame: Baseline
Body mass index (BMI) calculated from weight and stadiometer-measured height (kg/m²)
Time frame: Baseline
Peak force of mid-thigh-pull test measured by portable force dynamometer (N)
Time frame: Baseline
Handgrip strength measured by grip dynamometer (kg)
Time frame: Baseline
Timed Up-and-Go (TUG) test completion time (seconds)
Time frame: Baseline
Balance stability and speed score measured by TANITA force platform (unitless)
Time frame: Baseline
Percentage body fat measured by multifrequency bioimpedance analyzer InBody system (%)
Time frame: Baseline
Skeletal muscle mass measured by multifrequency bioimpedance analyzer InBody system (kg)
Time frame: Baseline
Waist circumference measured by flexible tape at midpoint between lowest rib and iliac crest (cm)
Time frame: Baseline
Hip circumference measured by flexible tape at level of greater trochanters (cm)
Time frame: Baseline
Serum triglycerides measured by enzymatic colorimetric assay (mg/dL)
Time frame: Baseline
Serum total cholesterol measured by enzymatic colorimetric assay (mg/dL)
Time frame: Baseline
Serum high-density lipoprotein (HDL) cholesterol measured by enzymatic assay (mg/dL)
Time frame: Baseline
Serum low-density lipoprotein (LDL) cholesterol calculated by Friedewald formula (mg/dL)
Time frame: Baseline
Serum 25-hydroxyvitamin D concentration measured by chemiluminescent immunoassay (ng/mL)
Time frame: Baseline
Mean daily sedentary time measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)
Time frame: Baseline
Mean nightly sleep duration measured by ActiGraph wGT3X-BT over 7 nights (hours/night)
Time frame: Baseline
Total physical activity measured by International Physical Activity Questionnaire - Long Form (MET·min/week)
Time frame: Baseline
Mediterranean Diet Adherence Score measured by 14-item Mediterranean Diet Adherence Screener (0 - 14 points)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this stage, the investigators have not yet decided whether our IPD will be shared. Data sharing policies and procedures are still under discussion within our research group and institution. Further consideration will be given to ethical requirements, participant privacy, and potential future analyses before making a final decision.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Inactivity, run by Technical University of Madrid at 1 site in Spain.
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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Jun 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songxin Tang (+34 663002621, songxin.tang@alumnos.upm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of brain-derived neurotrophic factor (BDNF) in plasma (pg/mL) (time frame: Baseline). The study lists 12 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 17 Jun 2025.