Clinical trial NCT07025070: The Link Between Physical Activity and Brain Health in Healthy Adults
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Inactivity
Preventive Therapy
Keywords: physical activity
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Region of Madrid

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of brain-derived neurotrophic factor (BDNF) in plasma (pg/mL)
timeFrame: Baseline
measure: Concentration of total tau protein in plasma (pg/mL)
timeFrame: Baseline
measure: Hippocampal volume measured by high-resolution 3 T T1-weighted MRI (mm³)
timeFrame: Baseline
measure: Resting-state functional connectivity between primary motor cortex and supplementary motor area measured by 3 T fMRI (Fisher-Z)
timeFrame: Baseline
measure: Digit Span Forward maximum span length (digits)
timeFrame: Baseline
measure: Trail Making Test Part A completion time (seconds)
timeFrame: Baseline
measure: Digit Span Backward maximum span length (digits)
timeFrame: Baseline
measure: Trail Making Test Part B completion time (seconds)
timeFrame: Baseline
measure: Verbal fluency (F-A-S) total words in 60 s (count)
timeFrame: Baseline
measure: Stroop Color-Word interference score (seconds)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MoCA) total score (0 - 30 points)
timeFrame: Baseline
measure: Number of participants carrying at least one APOE ε4 allele (count of participants)
timeFrame: Baseline
Secondary outcomes:
measure: Maximal oxygen uptake (VO₂max) measured by CPET with ramp protocol on treadmill (mL·kg-¹·min-¹)
timeFrame: Baseline
measure: Mean daily minutes of moderate-to-vigorous physical activity measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)
timeFrame: Baseline
measure: Body mass index (BMI) calculated from weight and stadiometer-measured height (kg/m²)
timeFrame: Baseline
measure: Peak force of mid-thigh-pull test measured by portable force dynamometer (N)
timeFrame: Baseline
measure: Handgrip strength measured by grip dynamometer (kg)
timeFrame: Baseline
measure: Timed Up-and-Go (TUG) test completion time (seconds)
timeFrame: Baseline
measure: Balance stability and speed score measured by TANITA force platform (unitless)
timeFrame: Baseline
measure: Percentage body fat measured by multifrequency bioimpedance analyzer InBody system (%)
timeFrame: Baseline
measure: Skeletal muscle mass measured by multifrequency bioimpedance analyzer InBody system (kg)
timeFrame: Baseline
measure: Waist circumference measured by flexible tape at midpoint between lowest rib and iliac crest (cm)
timeFrame: Baseline
measure: Hip circumference measured by flexible tape at level of greater trochanters (cm)
timeFrame: Baseline
measure: Serum triglycerides measured by enzymatic colorimetric assay (mg/dL)
timeFrame: Baseline
measure: Serum total cholesterol measured by enzymatic colorimetric assay (mg/dL)
timeFrame: Baseline
measure: Serum high-density lipoprotein (HDL) cholesterol measured by enzymatic assay (mg/dL)
timeFrame: Baseline
measure: Serum low-density lipoprotein (LDL) cholesterol calculated by Friedewald formula (mg/dL)
timeFrame: Baseline
measure: Serum 25-hydroxyvitamin D concentration measured by chemiluminescent immunoassay (ng/mL)
timeFrame: Baseline
measure: Mean daily sedentary time measured by ActiGraph wGT3X-BT accelerometer over 7 days (min/day)
timeFrame: Baseline
measure: Mean nightly sleep duration measured by ActiGraph wGT3X-BT over 7 nights (hours/night)
timeFrame: Baseline
measure: Total physical activity measured by International Physical Activity Questionnaire - Long Form (MET·min/week)
timeFrame: Baseline
measure: Mediterranean Diet Adherence Score measured by 14-item Mediterranean Diet Adherence Screener (0 - 14 points)
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Physical Activity and Sports Sciences (INEF)
Study officials:
References: