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

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

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).
Other: Supervised Exercise Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility
Time Frame: Baseline up to 4 weeks
Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month
Baseline up to 4 weeks
Intervention adherence
Time Frame: Up to 13 weeks
Measured as percent study sessions completed on-time (+/- 1 hour of the scheduled session) and the proportion of participants who achieved >75% adherence.
Up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

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

Keywords

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.

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