Healthy Aging Through Movement

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder
• Interventions: Other: Supervised Exercise Intervention

• Registration Number: NCT05772884
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study Start: 2022-05-11
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supervised Exercise Intervention	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).

Primary Outcome Measures

Name	Time	Method
Intervention adherence	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.
Recruitment feasibility	Baseline up to 4 weeks	Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States