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NCT Number: NCT07025070

The Link Between Physical Activity and Brain Health in Healthy Adults

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Physical Activity and Sports Sciences (INEF)

Madrid, 28040, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. Maximal oxygen uptake (VO₂max) measured by CPET with ramp protocol on treadmill (mL·kg-¹·min-¹)

    Time frame: Baseline

    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.

  2. Mean daily minutes of moderate-to-vigorous physical activity measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)

    Time frame: Baseline

    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.

  3. Body mass index (BMI) calculated from weight and stadiometer-measured height (kg/m²)

    Time frame: Baseline

    Height measured to 0.1 cm with height measuring rod. Weight obtained from InBody system. BMI = weight ÷ height². Higher BMI indicates greater overall adiposity.

  4. Peak force of mid-thigh-pull test measured by portable force dynamometer (N)

    Time frame: Baseline

    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.

  5. Handgrip strength measured by grip dynamometer (kg)

    Time frame: Baseline

    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.

  6. Timed Up-and-Go (TUG) test completion time (seconds)

    Time frame: Baseline

    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.

  7. Balance stability and speed score measured by TANITA force platform (unitless)

    Time frame: Baseline

    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.

  8. Percentage body fat measured by multifrequency bioimpedance analyzer InBody system (%)

    Time frame: Baseline

    Participants barefoot, InBody 770 provides whole-body fat percentage derived from segmental impedance; Higher values denote greater adiposity.

  9. Skeletal muscle mass measured by multifrequency bioimpedance analyzer InBody system (kg)

    Time frame: Baseline

    Analyzer outputs total skeletal muscle mass. Greater values indicate higher muscularity.

  10. Waist circumference measured by flexible tape at midpoint between lowest rib and iliac crest (cm)

    Time frame: Baseline

    Measured at end-expiration; two readings within 1 cm averaged. Larger values indicate central adiposity.

  11. Hip circumference measured by flexible tape at level of greater trochanters (cm)

    Time frame: Baseline

    Two readings averaged; used with waist girth to compute waist-to-hip ratio.

  12. Serum triglycerides measured by enzymatic colorimetric assay (mg/dL)

    Time frame: Baseline

    Fasting venous blood; triglycerides quantified on chemistry analyzer with glycerol phosphate oxidase method. Higher values indicate greater dyslipidemia risk.

  13. Serum total cholesterol measured by enzymatic colorimetric assay (mg/dL)

    Time frame: Baseline

    Chemistry analyzer; Cholesterol esterase/oxidase method. Higher levels indicate increased cardiovascular risk.

  14. Serum high-density lipoprotein (HDL) cholesterol measured by enzymatic assay (mg/dL)

    Time frame: Baseline

    Selective detergent method. Higher HDL is considered protective.

  15. Serum low-density lipoprotein (LDL) cholesterol calculated by Friedewald formula (mg/dL)

    Time frame: Baseline

    LDL-C = total-C - HDL-C - (triglycerides ÷ 5). Higher LDL indicates greater atherogenic risk.

  16. Serum 25-hydroxyvitamin D concentration measured by chemiluminescent immunoassay (ng/mL)

    Time frame: Baseline

    Serum 25-hydroxyvitamin D concentration measured by chemiluminescent immunoassay (ng/mL)

  17. Mean daily sedentary time measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)

    Time frame: Baseline

    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.

  18. Mean nightly sleep duration measured by ActiGraph wGT3X-BT over 7 nights (hours/night)

    Time frame: Baseline

    Sleep/wake scored with Cole-Kripke algorithm; average total sleep time across nights with ≥ 160 min valid sleep. Longer duration indicates better sleep quantity.

  19. Total physical activity measured by International Physical Activity Questionnaire - Long Form (MET·min/week)

    Time frame: Baseline

    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.

  20. Mediterranean Diet Adherence Score measured by 14-item Mediterranean Diet Adherence Screener (0 - 14 points)

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Songxin Tang

CONTACT

[email protected]

+34 663002621

Sponsors and collaborators

Lead sponsor

Technical University of Madrid

Other

Registry information

Official study title

The Link Between Strength and Endurance Training and Brain Health in Healthy Adults: A Comparative Study of Former Professional Athletes and Sedentary Individuals

Acronym: MINA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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