Healthy Aging Through Movement

Opioid Use Disorder Clinical Trial

— HELM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772884
• Other study ID #: IRB202002140
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: Lauren E Nieder, MSPH
• Phone: (352) 294-1067
• Email: lauren.nieder[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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