NCT07025070

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2024Sep 2026

Study Start

First participant enrolled

November 25, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

May 27, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

physical activity

Outcome Measures

Primary Outcomes (12)

  • 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.

    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.

    Baseline

  • Hippocampal volume measured by high-resolution 3 T T1-weighted MRI (mm³)

    Volume extracted with FreeSurfer; Larger values indicate greater hippocampal integrity

    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

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (20)

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

    Baseline

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

    Baseline

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

    Baseline

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

    Baseline

  • Handgrip strength measured by grip dynamometer (kg)

    Baseline

  • +15 more secondary outcomes

Study Arms (2)

Ex-athletes and continue to exercise regularly

Sedentary individuals

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Region of Madrid

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Activity and Sports Sciences (INEF)

Madrid, Madrid, 28040, Spain

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Detection of mutated genes associated with early-onset Alzheimer's disease

MeSH Terms

Conditions

Alzheimer DiseaseSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 17, 2025

Study Start

November 25, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations