Opioid Use DisorderHELMNCT05772884
Healthy Aging Through Movement
A study testing Supervised Exercise Intervention in people with Opioid Use Disorder, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Supervised Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Potential of Exercise to Reduce Pain and Enhance Mobility in Mid-life Adults Undergoing Opioid Use Treatment
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Supervised Exercise Intervention
- Keywords
- Pain, Exercise
- Medical subject headings
- Opioid-Related Disorders, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Intervention | Experimental | 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). Receives: Other: Supervised Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Number of participants screened and enrolled with reasons for ineligibility and non-participation recruitment rate (participants enrolled/month
Measured: Baseline up to 4 weeks
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.
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start11 May 2022
- Primary completion5 Sep 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same (single) intervention.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meredith S Berry, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772884
- Sponsor's protocol ID
- IRB202002140
- Acronym
- HELM
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Exercise to Reduce Pain and Enhance Mobility in Mid-life Adults Undergoing Opioid Use Treatment
- ClinicalTrials.gov ID
- NCT05772884
- Acronym / sponsor ID
- HELM / IRB202002140
- Conditions
- Opioid Use Disorder
- Keywords
- Pain, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same (single) intervention.
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Intervention | Experimental | Other: Supervised Exercise InterventionParticipants 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). |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Exercise InterventionExercise 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. | Other | Supervised Exercise Intervention |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No
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Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meredith S Berry, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Intervention in people with Opioid Use Disorder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Baseline up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.