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Completed

NCT Number: NCT05772884

Healthy Aging Through Movement

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.

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Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Motor Activity Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised Exercise Intervention

Other

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.

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

The Potential of Exercise to Reduce Pain and Enhance Mobility in Mid-life Adults Undergoing Opioid Use Treatment

Acronym: HELM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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