Healthy Aging Through Movement (HELM)
October 9, 2025 updated by: University of Florida
The Potential of Exercise to Reduce Pain and Enhance Mobility in Mid-life Adults Undergoing Opioid Use Treatment
This study aims to examine the effectiveness of a supervised aerobic exercise program for persons with Opioid Use Disorder (OUD).
Participants will be enrolled in a 12-week supervised aerobic exercise intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overall project goals are to test the feasibility and acceptability of our aerobic exercise intervention with this population.
Study participation will include a screening and enrollment phase, a baseline assessment, and a 12-week intervention.
Participants will be recruited and consented by University of Florida (UF) study staff.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults must be aged 21-64 years old
- Currently enrolled in OMT (opioid maintenance treatment) or present with at least mild opioid use disorder (endorses at least 2 DSM-V criteria for OUD within a 12-month period),
- Insufficiently physically active (defined as exercising < 20 minutes 3 times/week
- Able to understand and speak English
- Have a body mass index 18.5-40 kg/m^2
- Willing and able to visit research center up to one time time/week for 12 weeks
- Participants will undergo a supervised maximal exercise test and physical exam by medical supervisor to be cleared for participation.
Exclusion Criteria:
- Participants must not have heart disease, or had a stroke, uncontrolled diabetes, thyroid condition an eating disorder
- An uncontrolled major psychiatric condition (e.g., schizophrenia; conditions that are well-controlled, however [e.g., anxiety controlled through therapy] will not be exclusionary), or other medical condition(s) that contraindicate exercise; and may not be participating in a structured exercise training or weight loss program.
- Participants cannot be pregnant; pregnancy is exclusionary
- One individual per household may enroll.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supervised Exercise 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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Exercise duration will be gradually increased as tolerated to 50 min/session, with intensity ramping up to 65-75% HRmax by week 3. On-site exercise sessions will occur along a pre-marked walking path, and a trained staff member will walk alongside the participant to monitor their heart rate.
Speed will be manipulated to achieve desired intensity and to sustain heart rate in the target zone.
Heart rate will be monitored and recorded via telemetry during the on-site exercise sessions.
Step cadence (i.e., steps/minute) will also be monitored and recorded during the on-site sessions and discussed with participants as a way to understand and track their speed when completing off-site walking sessions on their own.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recruitment feasibility
Time Frame: Baseline up to 4 weeks
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Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month
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Baseline up to 4 weeks
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Intervention adherence
Time Frame: Up to 13 weeks
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Measured as percent study sessions completed on-time (+/- 1 hour of the scheduled session) and the proportion of participants who achieved >75% adherence.
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Up to 13 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meredith S Berry, PhD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2022
Primary Completion (Actual)
September 5, 2025
Study Completion (Actual)
October 9, 2025
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 16, 2023
Study Record Updates
Last Update Posted (Estimated)
October 14, 2025
Last Update Submitted That Met QC Criteria
October 9, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202002140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.