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Healthy Aging Through Movement (HELM)

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University of Florida

Status

Completed

Conditions

Opioid Use Disorder

Treatments

Other: Supervised Exercise Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05772884
IRB202002140

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

21 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Supervised Exercise Intervention
Experimental group
Description:
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).
Treatment:
Other: Supervised Exercise Intervention

Trial contacts and locations

1

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Central trial contact

Lauren E Nieder, MSPH

Data sourced from clinicaltrials.gov

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