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Clinical Trials/NCT05772884
NCT05772884
Completed
N/A

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

University of Florida1 site in 1 country6 target enrollmentMay 11, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
University of Florida
Enrollment
6
Locations
1
Primary Endpoint
Intervention adherence
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2022
End Date
October 9, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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

Study Sites (1)

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