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Eine Studie entspricht den Filterkriterien
Kartenansicht
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05522075 ist eine interventionsstudie zur Untersuchung von Alkoholkonsum, Rauschtrinken, Blutdruck, Alcohol Abstinence, Altern, Lebensstilfaktoren, Vasodilatation, Verhaltensproblem und hat den Status offene rekrutierung. Die Studie startete am 21. November 2022 und soll 55 Teilnehmer aufnehmen. Durchgeführt von The University of Texas at Arlington ist der Abschluss für 30. April 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 7. November 2025 aktualisiert.
Kurzbeschreibung
This study has two phases:
Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers.
Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers
Ausführliche Beschreibung
During phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. Only mid-life adult binge drinkers will enter Phase 2 and be randomized to the exercise training group and non-exercise control group. After 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.
Offizieller Titel
Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity
Erkrankungen
AlkoholkonsumRauschtrinkenBlutdruckAlcohol AbstinenceAlternLebensstilfaktorenVasodilatationVerhaltensproblemWeitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2022-11-21
Zuletzt aktualisiert
2025-11-07
Studienende (vorauss.)
2026-04-30
Geplante Rekrutierung
55
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Exercise training
High-intensity interval training
Midlife adults
Middle-aged
Microvascular function
Sympathetic nerve activity
High-intensity interval training
Midlife adults
Middle-aged
Microvascular function
Sympathetic nerve activity
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellExercise Group Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment. | Bewegungstraining Subjects will be asked to perform exercise training (high-intensity interval training) under supervision, 3 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax. Alcohol Abstinence Intervention Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided. |
Aktives VergleichspräparatNon-exercise Group Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment. | Alcohol Abstinence Intervention Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided. |
Keine InterventionAlcohol abstainer/moderate drinker group Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention. | Nicht zutreffend |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Feasibility of high-intensity interval training | Recruitment capacity (e.g., how many subjects respond and enter to the study or reasons of refusal), resulting subject characteristics, the number of exercise session attended, and the number of dropouts | Through out the study participation (~3 months) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Changes in microvascular function | A small amount of fat will be taken form the buttock. Small vessels will then be found in the fat and their sizes in response to various flows and chemical agents will be measured. | Baseline and after an 8-week intervention |
Changes in sympathetic activity | A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min). | Baseline and after an 8-week intervention |
Changes in urine catecholamine levels | Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g) | Baseline and after an 8-week intervention |
Changes in blood pressure | Systolic and Diastolic blood pressure will be measured at rest and for 24 hours. | Baseline and after an 8-week intervention |
Changes in alcohol intake | Questionnaires will be used to determine alcohol intake. | Baseline and after an 8-week intervention |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene
Mindestalter
50 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink
- Female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr).
- Subjects who can speak and understand English.
- a history of diabetes, cardiovascular disease, liver, or renal disease
- current or history of smoking and illicit drug use
- blood pressure ≥160/100 mm Hg
- other known traditional cardiovascular disease risks: obesity (BMI≥35 kg/m2), or hyperlipidemia (total cholesterol>230 mg/dl and/or LDL cholesterol>160 mg/dl)
- active infection (in the past 2 months)
- a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid)
- unstable body weight (>5% change during the past 6 months)
- regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week)
- current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)
The University of Texas at ArlingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Zentrale Studienkontakte
Kontakt: Chueh-Lung Hwang, PhD, 8172729722, [email protected]
1 Studienstandorte in 1 Ländern
Texas
University of Texas at Arlington, Arlington, Texas, 76010, United States
Chueh-Lung Hwang, PhD, PT, Kontakt, 817-272-9722, [email protected]
Offene Rekrutierung