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Supervised Exercise for Opioid Use Disorder (HELM Trial)
N/A
Recruiting
Led By Meredith S Berry, PhD
Research Sponsored by University of Florida
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 up to 13 weeks
Awards & highlights
HELM Trial Summary
This trial will look at how aerobic exercise can help people with Opioid Use Disorder. Participants join a 12-week supervised exercise program to see if it helps.
Who is the study for?
This trial is for adults aged 21-64 with mild to severe Opioid Use Disorder, who are not very active physically and can visit the research center weekly for 12 weeks. They must be able to exercise safely as determined by a medical exam. Pregnant individuals, those in other exercise or weight loss programs, or with certain medical conditions like heart disease or uncontrolled diabetes cannot join.Check my eligibility
What is being tested?
The study tests a supervised aerobic exercise program over 12 weeks to see if it helps people with Opioid Use Disorder. Participants will engage in regular physical activity under supervision and their progress will be monitored throughout the program.See study design
What are the potential side effects?
While specific side effects are not listed for exercising, participants may experience typical workout-related discomforts such as muscle soreness, fatigue, or minor injuries. A medical supervisor will ensure exercises are done safely.
HELM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intervention adherence
Recruitment feasibility
HELM Trial Design
1Treatment groups
Experimental Treatment
Group I: Supervised Exercise InterventionExperimental Treatment1 Intervention
Participants will be asked to complete 3 walking sessions per week for 12 weeks. We will ask them to complete at least 1 of these sessions in-person on-site and they will be given the option to complete up to 2 walking sessions per week off-site. Exercise training on-site will be performed on an indoor walking path, 50 min/session (plus 5 min. for each warm-up and cool down).
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,616 Total Patients Enrolled
Meredith S Berry, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
45 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart condition, stroke history, uncontrolled diabetes, thyroid issues, or an eating disorder.I am between 21 and 64 years old.I have passed a physical exam and exercise test to join.I can visit the research center weekly for 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Supervised Exercise Intervention
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for octogenarians to partake in this research study?
"To comply with the study's enrollment conditions, potential participants must be of age 21 to 64."
Answered by AI
Who is eligible to partake in this medical study?
"This research trial has a cap of 30 participants, all of whom must have an opioid use disorder and be between the ages 21-64."
Answered by AI
Is the recruitment phase of this trial still open?
"The most recent data held on clinicaltrials.gov affirms that this investigation, which was initially advertised in May of 2022, is actively enrolling participants. It has since been updated as recently as March 16th 2023."
Answered by AI
How many participants has this research recruited?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively searching for participants - it was initially posted on May 11th 2022 and was last updated on March 16th 2023. The study needs 30 patients recruited from 1 site."
Answered by AI
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