- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07775196
Aging and Exercise Impacts on Glymphatic Function
Impact of Aging and Exercise on Glymphatic Function Using Multi-modal MRI
This is a prospective, interventional, non-blinded, single center research project that will recruit cognitively unimpaired subjects in the 25-55 year old and 55-75 year old range. This study will use acute aerobic exercise as a natural intervention model to increase cardiac activity which may further drive the glymphatic function. There will be no randomization, and all enrolled subjects will participate in the exercise session.
Hypotheses: revealed by the multi-modal magnetic resonance imaging (MRI) approach, glymphatic dysfunction increases with age and is associated with preclinical Alzheimer's Disease (AD) pathology in cognitively unimpaired individuals. Using acute aerobic exercise as a human model, the enhancement of cerebrospinal fluid-interstitial fluid (CSF-ISF) exchange caused by elevated cardiac activity and paravascular cerebrospinal fluid (pCSF) dynamics can be validated.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jiaen Liu, Ph.D.
- Telefonnummer: 612/423-8380
- E-Mail: Jiaen.Liu@UTSouthwestern.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- age 25-75 years old
- cognitively unimpaired (CU)
- Mini-Mental State Examination (MMSE) score ≥27 at enrollment screening
- matched gender
- all racial/ethnic groups
Exclusion Criteria:
- pregnant women
- history of stroke or other major cerebrovascular disease;
- diagnosis of Alzheimer's disease (AD) or other types of dementia;
- diagnosis of major neurologic and psychiatric disorders (e.g., Parkingson's disease, major depression);
- history of prior head trauma, significant autoimmune disorders,
- sleep apnea;
- major systemic illness likely to affect the central nervous system, e.g., uncontrolled diabetes, severe cardiovascular disease, cancer, etc.;
- prior or current alcoholism or drug abuse;
- resistant hypertension (SBP ≥140 or DBP ≥ 90 mmHg despite 3 antihypertensive drugs at maximal doses);
- orthostatic hypotension defined as the third standing systolic blood pressure (SBP) < 100mmHg; any contraindications to having a MRI, e.g., claustrophobia, pacemaker or other medical device of metal;
- any conditions judged by the investigators to be medically inappropriate, risky or likely to cause poor study compliance.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Acute aerobic exercise- Interventional Group
This group will include all enrolled participants from all age groups, will receive MRI scans for glymphatic function and participate in acute aerobic exercise (intervention) between MRI sessions.
They may / may not undergo PET scans.
|
During the MRI session, subject will perform aerobic exercise on a MR-compatible ergometer and will be guided to reach certain heart rate level depending on subject's age.
Their vital signs will be closely monitored by the research team to ensure safety.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Exercise-induced changes in heart rate (HR)
Zeitfenster: Baseline (pre-exercise), immediately post-exercise
|
During exercise, HR will be continuously monitored using photoplethysmography (ppg) by a device attached to a finger of the subjects.
|
Baseline (pre-exercise), immediately post-exercise
|
|
Exercise-induced changes in cardiac output (CO)
Zeitfenster: Baseline (pre-exercise), immediately post-exercise
|
During exercise, CO will be calculated based on HR and real time blood pressure (BP) acquired on the index finger using an MRI-compatible device.
|
Baseline (pre-exercise), immediately post-exercise
|
|
Exercise-induced changes in MRI measurements of pCSF dynamics
Zeitfenster: Baseline (pre-exercise), immediately post-exercise
|
pCSF will be assessed using MRI in the brain.
|
Baseline (pre-exercise), immediately post-exercise
|
|
Exercise-induced changes in MRI measurements of CSF-ISF exchange
Zeitfenster: Baseline (pre-exercise), immediately post-exercise
|
CSF-ISF exchange will be assessed using MRI in the brain.
|
Baseline (pre-exercise), immediately post-exercise
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Jiaen Liu, Ph.D., University of Texas Southwestern Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU20260916
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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