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Alcohol Abstinence + Exercise for High Blood Pressure
N/A
Recruiting
Led By Chueh-Lung Hwang, PhD
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through out the study participation (~3 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will have two phases. In the first, researchers will compare blood pressure, microvascular function, and sympathetic nerve activity in mid-life adults who binge drink with those who abstain or drink moderately. In the second phase, they will examine the effect of 8 weeks of aerobic exercise training on those same measures in the binge drinkers.
Who is the study for?
This trial is for non-smoking men and women aged 50-64 who are postmenopausal, do not use drugs, and have varying alcohol consumption habits. It's not for those with high blood pressure, recent infections, diabetes, heart/liver/kidney disease, obesity or high cholesterol. Regular exercisers and hormone therapy users are also excluded.
What is being tested?
The study investigates how abstaining from alcohol and engaging in an 8-week aerobic exercise program affects blood pressure and vascular function in mid-life adults who binge drink compared to those who don't drink or drink moderately.
What are the potential side effects?
While the trial itself may not directly cause side effects, participants might experience withdrawal symptoms if they're used to heavy drinking. Exercise can lead to muscle soreness or injury if not done properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through out the study participation (~3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through out the study participation (~3 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of high-intensity interval training
Secondary study objectives
Changes in alcohol intake
Body Weight Changes
Changes in microvascular function
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Exercise GroupExperimental Treatment2 Interventions
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.
Group II: Non-exercise GroupActive Control1 Intervention
Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.
Group III: Alcohol abstainer/moderate drinker groupActive Control1 Intervention
Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Training
2011
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,715 Total Patients Enrolled
The University of Texas at ArlingtonLead Sponsor
44 Previous Clinical Trials
4,810 Total Patients Enrolled
Chueh-Lung Hwang, PhDPrincipal InvestigatorUniversity of Texas at Arlington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50 and 64 years old and I may or may not drink alcohol.My weight has been stable, with less than a 5% change in the past 6 months.I have not had an infection in the last 2 months.I have a history of seizures, cancer, or inflammatory diseases like gout or rheumatoid arthritis.I have not had a menstrual period for at least one year.I am currently using hormone replacement therapy.I have a history of diabetes, heart, liver, or kidney disease.I am obese or have very high cholesterol.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group
- Group 2: Non-exercise Group
- Group 3: Alcohol abstainer/moderate drinker group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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