Healthy Aging Through Movement

NCT05772884 | Completed DMC

• 1 other identifier: IRB202002140
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

Pain; Exercise

Outcome Measures

Primary Outcomes (2)

• Recruitment feasibility

  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

  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

Study Arms (1)

Supervised Exercise Intervention

EXPERIMENTAL

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

Interventions

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.

Supervised Exercise Intervention

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants must not have heart disease, or had a stroke, uncontrolled diabetes, thyroid condition an eating disorder
• One individual per household may enroll.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Meredith S Berry, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive the same (single) intervention.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 16, 2023
• Study Start: May 11, 2022
• Primary Completion: September 5, 2025
• Study Completion: October 9, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)