DepressionNCT06149624
Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
A study testing upfront advice to walk and Supervised exercise in people with Depression and Hiv, run by University of Minnesota at 1 site in United States.
Trial summary
Depression in people living with HIV is associated with worse care engagement, drug adherence, and higher rates of pre-mature mortality. The prevalence of depression is three times greater in those with HIV than comparable controls. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Depression, Hiv
- What is being tested?
- upfront advice to walk and Supervised exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 15 Apr 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Enrolled in Mildmay HIV clinic
- Adults 18-45 years old
- HIV positive
- Receiving HIV therapy
- HIV viral suppression (\<400 copies/mL) per chart review
- Mild to Moderate (PHQ9 score \>5 but \>20)
Show all 9Show fewer
- Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking
- Able to walk/run on a treadmill
- Informed consent
Who cannot join
- Women pregnant or breastfeeding
- Suicidal (PHQ-9 question 9 score >2) or Severely Depressed (PHQ-9 score >20)
- Uncontrolled hypertension (≥180 systolic or ≥100 diastolic blood pressure)
- Lower limb orthopedic limitations (e.g. amputations, arthritis)
- Resting heart rate >90/min
- Known atherosclerotic or non-atherosclerotic peripheral artery disease.
- Exercise intolerance due to other known medical condition(s) which may make it unsafe for the patients to participate in.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Depression in people living with HIV is associated with worse care engagement, drug adherence, and higher rates of pre-mature mortality. The prevalence of depression is three times greater in those with HIV than comparable controls. While antiretroviral therapy (ART) enables immune reconstitution, those with depression do worse clinically than those without depression even when controlling for HIV stage. However, treating depression in HIV-infected persons is challenging. Even among those virologically suppressed on ART, a significant percentage are resistant to standard pharmacotherapy or psychotherapy for depression. The reasons for this are complex and poorly understood. An emerging body of evidence indicates that inflammation may perpetuate depression. Given people with HIV have ongoing increased inflammation, this could help explain part of why depression rates are so high in people with HIV.
Treatments for HIV-associated depression would likely be more effective if they were anti- inflammatory in nature. One possible treatment is exercise. Exercise is acutely pro-inflammatory due to catabolism but in the long term is anti-inflammatory. However, few studies have investigated exercise as a treatment for HIV-associated depression. The study objective is to perform a feasibility study to evaluate a larger trial evaluating the efficacy of exercise as an intervention for depression in people with HIV.
- Conditions
- Depression, Hiv
- Being tested
- upfront advice to walk, Supervised exercise
- Medical subject headings
- Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upfront advice to walkBehavioural
Control participants will be given upfront advice to walk and also given the wearable activity monitor (Fitbit) and asked to record the total steps achieved each day in a provided log book.
Supervised exerciseBehavioural
The onsite physiotherapist will also be trained in appropriate supervision and monitoring of exercise therapy in participants with HIV. This training will include titration of the exercise prescription to ensure safe progress is achieved. Participants will be scheduled to come to Mildmay 2 times per week for eight weeks to perform treadmill walking exercise. Intensity will be regulated using 40-60% of heart rate reserve. Additionally, ratings of perceived exertion via the Adult OMNI Walk/Run Scale will be used to guide the intensity of exercise subjectively at a moderate level. The exercise dose participants complete are standard prescriptions for participants with HIV, according to the American College of Sports Medicine.19 The physiotherapist will document the total steps achieved, including the supervised treadmill sessions and activity completed outside the supervised exercise setting (provided by participants via a log book).
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | participants randomized to control group Receives: Behavioral: upfront advice to walk |
| Intervention group | Experimental | participants randomized to intervention group Receives: Behavioral: Supervised exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent completion of the prescribed aerobic exercise intervention
assessed by research staff logging participation
Measured: 8 weeks
Secondary outcomes (11)
acceptability of the intervention
assessed via post intervention survey
Measured: 8 weeks
feasibility of using a wearable exercise tracker 2
calories burned during the intervention period among Ugandans with HIV and depression
Measured: 8 weeks
feasibility of using a wearable exercise tracker 1
assess the volume of exercise based on steps achieved, during the intervention period among Ugandans with HIV and depression
Measured: 8 weeks
effect size
- measure the mean and standard deviation of baseline and 8-week serum BDNF level to estimate an effect size
Measured: baseline and 8 weeks
effect size
- measure the mean and standard deviation of baseline and 8-week serum IL-6 level to estimate an effect size
Measured: baseline and 8 weeks
power estimate
- measure the mean and standard deviation of baseline and 8-week serum BDNF to power a future study
Measured: baseline and 8 weeks
power estimate
- measure the mean and standard deviation of baseline and 8-week serum IL-6 level to power a future study
Measured: baseline and 8 weeks
depression score
depression score via PHQ-9
Measured: baseline and 8 weeks
aerobic fitness
measure the mean aerobic fitness at baseline and at 8 weeks measured via METS/watts achieved
Measured: Baseline and 8 weeks
aerobic fitness
measure the total time/distance achieved
Measured: Baseline and 8 weeks
effect size for a future intervention
measure the mean and standard deviation for total time/distance to estimate the effect size for a future intervention.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jul 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lofgren, PhD, Principal investigator, University of MinnesotaRyan Mays, PhD, Principal investigator, University of MinnesotaAnita Arinda, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149624
- Sponsor's protocol ID
- MED-2023-32453
- Status last verified
- May 2025
- First submitted
- 29 Oct 2023
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
- ClinicalTrials.gov ID
- NCT06149624
- Acronym / sponsor ID
- MED-2023-32453
- Conditions
- Depression, Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 29 Nov 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.
Depression in people living with HIV is associated with worse care engagement, drug adherence, and higher rates of pre-mature mortality. The prevalence of depression is three times greater in those with HIV than comparable controls. While antiretroviral therapy (ART) enables immune reconstitution, those with depression do worse clinically than those without depression even when controlling for HIV stage. However, treating depression in HIV-infected persons is challenging. Even among those virologically suppressed on ART, a significant percentage are resistant to standard pharmacotherapy or psychotherapy for depression. The reasons for this are complex and poorly understood. An emerging body of evidence indicates that inflammation may perpetuate depression. Given people with HIV have ongoing increased inflammation, this could help explain part of why depression rates are so high in people with HIV.
Treatments for HIV-associated depression would likely be more effective if they were anti- inflammatory in nature. One possible treatment is exercise. Exercise is acutely pro-inflammatory due to catabolism but in the long term is anti-inflammatory. However, few studies have investigated exercise as a treatment for HIV-associated depression. The study objective is to perform a feasibility study to evaluate a larger trial evaluating the efficacy of exercise as an intervention for depression in people with HIV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Behavioral: upfront advice to walkparticipants randomized to control group |
| Intervention group | Experimental | Behavioral: Supervised exerciseparticipants randomized to intervention group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Enrolled in Mildmay HIV clinic
- Adults 18-45 years old
- HIV positive
- Receiving HIV therapy
- HIV viral suppression (\<400 copies/mL) per chart review
Key exclusion criteria (7 listed)
- Women pregnant or breastfeeding
- Suicidal (PHQ-9 question 9 score >2) or Severely Depressed (PHQ-9 score >20)
- Uncontrolled hypertension (≥180 systolic or ≥100 diastolic blood pressure)
- Lower limb orthopedic limitations (e.g. amputations, arthritis)
- Resting heart rate >90/min
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 |
|---|---|---|
| upfront advice to walkControl participants will be given upfront advice to walk and also given the wearable activity monitor (Fitbit) and asked to record the total steps achieved each day in a provided log book. | Behavioural | control |
| Supervised exerciseThe onsite physiotherapist will also be trained in appropriate supervision and monitoring of exercise therapy in participants with HIV. This training will include titration of the exercise prescription to ensure safe progress is achieved. Participants will be scheduled to come to Mildmay 2 times per week for eight weeks to perform treadmill walking exercise. Intensity will be regulated using 40-60% of heart rate reserve. Additionally, ratings of perceived exertion via the Adult OMNI Walk/Run Scale will be used to guide the intensity of exercise subjectively at a moderate level. The exercise dose participants complete are standard prescriptions for participants with HIV, according to the American College of Sports Medicine.19 The physiotherapist will document the total steps achieved, including the supervised treadmill sessions and activity completed outside the supervised exercise setting (provided by participants via a log book). | Behavioural | Intervention group |
Primary outcome
Percent completion of the prescribed aerobic exercise intervention
Time frame: 8 weeks
assessed by research staff logging participation
11 secondary outcomes
acceptability of the intervention
Time frame: 8 weeks
feasibility of using a wearable exercise tracker 2
Time frame: 8 weeks
feasibility of using a wearable exercise tracker 1
Time frame: 8 weeks
effect size
Time frame: baseline and 8 weeks
effect size
Time frame: baseline and 8 weeks
power estimate
Time frame: baseline and 8 weeks
power estimate
Time frame: baseline and 8 weeks
depression score
Time frame: baseline and 8 weeks
aerobic fitness
Time frame: Baseline and 8 weeks
aerobic fitness
Time frame: Baseline and 8 weeks
effect size for a future intervention
Time frame: Baseline and 8 weeks
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 30 May 2025.
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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.
Sarah Lofgren, PhD principal investigator
University of Minnesota
Ryan Mays, PhD principal investigator
University of Minnesota
Anita Arinda, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upfront advice to walk and Supervised exercise in people with Depression and Hiv, run by University of Minnesota 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 9 inclusion and 7 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 30 May 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. Some participants in this study may receive a placebo. 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?
Percent completion of the prescribed aerobic exercise intervention (time frame: 8 weeks). 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 30 May 2025.