Healthy Aging Through Movement - Clinical Trial for Opioid Use Disorder | NCT05772884

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Supervised Exercise Intervention

About this trial

This is an interventional basic science trial for Opioid Use Disorder focused on measuring Pain, Exercise

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesAccepts 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.

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supervised Exercise Intervention

Arm 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).

Outcomes

Primary Outcome Measures

Recruitment feasibility

Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05772884

First Posted

February 21, 2023

Last Updated

March 16, 2023

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT05772884

Brief Title

Healthy Aging Through Movement

Acronym

HELM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 11, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use Disorder

Keywords

Pain, Exercise

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All participants receive the same (single) intervention.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supervised Exercise Intervention

Arm Type

Experimental

Arm 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).

Intervention Type

Other

Intervention Name(s)

Supervised Exercise Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment feasibility

Description

Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month

Time Frame

Baseline up to 4 weeks

Title

Intervention adherence

Description

Measured as percent study sessions completed on-time (+/- 1 hour of the scheduled session) and the proportion of participants who achieved >75% adherence.

Time Frame

Up to 13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren E Nieder, MSPH

Phone

(352) 294-1067

Email

lauren.nieder@ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meredith S Berry, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauren E Nieder, MSPH

Phone

352-294-1067

Email

lauren.nieder@ufl.edu

First Name & Middle Initial & Last Name & Degree

Meredith S Berry, PhD

First Name & Middle Initial & Last Name & Degree

Danielle Jake-Schoffman, PhD

12. IPD Sharing Statement

Plan to Share IPD

No

Healthy Aging Through Movement (HELM)

Opioid Use Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial