NCT06378515

Brief Summary

This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

April 17, 2024

Last Update Submit

August 12, 2024

Conditions

Keywords

glympathic systembrain healthphysical activityneurohydrodynamics

Outcome Measures

Primary Outcomes (1)

  • Brain health

    The data collected through the Glymphometer allows us to obtain the variable known as the G-index, which describes the activity of the glymphatic system. This G-index is based on 14 (patented) algorithms. The G-index ranges from 0 to 100, with higher brain health the higher the score Brain health through the G-Index. Data collected through the Glymphometer allows us to obtain the variable known as the G-index, which describes the activity of the glymphatic system. This G-index is based on 14 (patented) algorithms and ranges from 0 to 100, with higher brain health the higher the score.

    Basal, during 15 minutes

Secondary Outcomes (6)

  • Physical activity (habitual)

    Basal

  • Sleep duration

    Basal

  • Sleep Quality

    Basal

  • Chronotype

    basal

  • Self-reported health status

    Basal

  • +1 more secondary outcomes

Interventions

1. Measuring while patients are sitting in rest for 5 minutes. 2. Supine to stand test: lying down (5 min) standing up (5 min) 3. Repeated sit stand test: sitting (10 sec) ↔ standing (10 sec), changing position every 10 seconds for 5 minutes. 4. Paced breathing in sitting position: letting patients breath 6 breaths/minute (0.1Hz) for 5 minutes. 5. Breath hold manoeuvre in sitting position: 60s normal breathing, then 32s breath hold + 88s normal breathing repeated 3 times. 6. Arithmetic stress test by giving the subject single digit addition. To give the pressure, subject needs to do as many as possible calculation within 1 minute with 1 minute break. This is repeated 3 times.

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

University students

You may qualify if:

  • Students enrolled in a bachelor's degree from one of the universities participating in the study.
  • Students who consent to participate in the study indicating that they have been informed of all relevant aspects of the study.

You may not qualify if:

  • Students under the age of 18.
  • Students with cognitive or sensory difficulties or with insufficient command of the language that, in the opinion of the recruiting professional, makes it difficult to understand the questions raised in the surveys, scales or instruments used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de València

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Brain DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Raquel Faubel, PhD

    Universitat de València

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Faubel, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Physiotherapy

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

May 1, 2024

Primary Completion

April 1, 2025

Study Completion

December 1, 2025

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Anonymous data of the participants is planned to be shared with other researchers for scientific reasons.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
after the data collection
Access Criteria
Data will be available based on the criteria of the main researcher

Locations