Prolonged InactivityNCT07296991
VR Stimulation of Exercise Response in Sedentary Humans
A study testing 20 minutes cycling exercise and Virtual Reality in people with Prolonged Inactivity and Metabolic Syndrome, run by Wayne State University at 1 site in United States.
Trial summary
Prolonged sedentary conditions contribute to declining health across human populations and cause significant secondary health consequences for many patients whose illnesses or injuries prevent them from exercising. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Prolonged Inactivity, Metabolic Syndrome
- What is being tested?
- 20 minutes cycling exercise and Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Equal numbers male and female (32 each)
- Blood glucose HbA1C: 5.7-6.4% or 100-125 mg/dL
- BP: systolic<120 and diastolic<80 mmHg, systolic 120-129 mmHg and diastolic <80 mmHg, or systolic >130 mmHg and diastolic >80 mmHg
Who cannot join
- BMI>35kg/m2
- Currently involved in an exercise program or similar activity
- Taking medications that could affect results, including beta-blockers or SSRIs
- Demonstrate any form of discomfort with the VR experience through self-reported feelings of anxiety or nausea
- Alcohol consumption above a minimal level(<2 oz/night)
- BP: Systolic >160 mmHg and Diastolic >110 mmHg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert J Wessells, PhD contact
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Alyson Sujkowski, PhD, 419-461-4317, asujkows@med.wayne.edu
Robert J Wessells, PhD, 734-476-4325, rwessell@med.wayne.edu
About this study
Prolonged sedentary conditions contribute to declining health across human populations and cause significant secondary health consequences for many patients whose illnesses or injuries prevent them from exercising. The investigators have demonstrated that in a small animal fruit fly model, genetic stimulation of neurons that promote adrenergic signaling is sufficient to mimic the benefits of exercise training even in sedentary animals. The investigator's pilot work in humans has confirmed that humans respond to Virtual Reality (VR) stimuli that mimic exercise by increasing heart rate and altering heart rate variability in a way consistent with increased adrenergic activity.
In this study, the investigators will directly test for the first time whether repeated, controlled exposure to VR stimuli that induce adrenergic activity in sedentary humans can produce adaptive changes to protein expression and endurance performance like those produced by actual exercise in pre-diabetic participants with/without hypertension.
- Conditions
- Prolonged Inactivity, Metabolic Syndrome
- Being tested
- 20 minutes cycling exercise, Virtual Reality
- Keywords
- Exercise, metabolic syndrome, insulin resistance, virtual reality
- Medical subject headings
- Metabolic Syndrome, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 minutes cycling exerciseBehavioural
20 minutes cycling exercise
Virtual RealityBehavioural
20 minutes virtual cycling
| Study group | Role | What they receive |
|---|---|---|
| EX-20 minutes sub max cycling exercise | Active comparator | 20 minutes cycling exercise Receives: Behavioral: 20 minutes cycling exercise |
| VR-virtual reality exercise | Experimental | 20 minutes virtual cycling Receives: Behavioral: Virtual Reality |
| VR+: 20 minutes sub max cycling exercise + virtual reality | Active comparator | 20 minutes cycling exercise + 20 minutes virtual cycling Receives: Behavioral: 20 minutes cycling exercise; Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose, HbA1C
Pre-diabetic patients (Blood glucose 100-125 mg/dL, AbA1C 5.7-6.4%) may see improvement in values post-intervention
Measured: 10 weeks
Secondary outcomes (1)
10 minute walk time
distance walked in 10 minutes is recorded pre- and post- intervention and may improve
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start30 Sep 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged InactivityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Alyson Sujkowski, Wayne State University
- Investigators
- Robert J Wessells, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296991
- Sponsor's protocol ID
- IRB-23-06-5927
- Other IDs
- 5R01AG059683-07
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from human studies will be shared in aggregate and/or deidentified form at the time of publication and backed up on shared drives among the study personnel according to the terms of the Institutional Review Board and the approved consent forms. Identifying data will be kept in a locked cabinet under supervision of the PI and destroyed at the conclusion of the study
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR Stimulation of Exercise Response in Sedentary Humans
- ClinicalTrials.gov ID
- NCT07296991
- Acronym / sponsor ID
- IRB-23-06-5927
- Conditions
- Prolonged Inactivity, Metabolic Syndrome
- Keywords
- Exercise, metabolic syndrome, insulin resistance, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Dec 2025 (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.
Prolonged sedentary conditions contribute to declining health across human populations and cause significant secondary health consequences for many patients whose illnesses or injuries prevent them from exercising. The investigators have demonstrated that in a small animal fruit fly model, genetic stimulation of neurons that promote adrenergic signaling is sufficient to mimic the benefits of exercise training even in sedentary animals. The investigator's pilot work in humans has confirmed that humans respond to Virtual Reality (VR) stimuli that mimic exercise by increasing heart rate and altering heart rate variability in a way consistent with increased adrenergic activity.
In this study, the investigators will directly test for the first time whether repeated, controlled exposure to VR stimuli that induce adrenergic activity in sedentary humans can produce adaptive changes to protein expression and endurance performance like those produced by actual exercise in pre-diabetic participants with/without hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EX-20 minutes sub max cycling exercise | Active comparator | Behavioral: 20 minutes cycling exercise20 minutes cycling exercise |
| VR-virtual reality exercise | Experimental | Behavioral: Virtual Reality20 minutes virtual cycling |
| VR+: 20 minutes sub max cycling exercise + virtual reality | Active comparator | Behavioral: 20 minutes cycling exercise, Behavioral: Virtual Reality20 minutes cycling exercise + 20 minutes virtual cycling |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Equal numbers male and female (32 each)
- Blood glucose HbA1C: 5.7-6.4% or 100-125 mg/dL
- BP: systolic<120 and diastolic<80 mmHg, systolic 120-129 mmHg and diastolic <80 mmHg, or systolic >130 mmHg and diastolic >80 mmHg
Key exclusion criteria (6 listed)
- BMI>35kg/m2
- Currently involved in an exercise program or similar activity
- Taking medications that could affect results, including beta-blockers or SSRIs
- Demonstrate any form of discomfort with the VR experience through self-reported feelings of anxiety or nausea
- Alcohol consumption above a minimal level(<2 oz/night)
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 |
|---|---|---|
| 20 minutes cycling exercise20 minutes cycling exercise | Behavioural | EX-20 minutes sub max cycling exercise, VR+: 20 minutes sub max cycling exercise + virtual reality |
| Virtual Reality20 minutes virtual cycling | Behavioural | VR+: 20 minutes sub max cycling exercise + virtual reality, VR-virtual reality exercise |
Primary outcome
Blood Glucose, HbA1C
Time frame: 10 weeks
Pre-diabetic patients (Blood glucose 100-125 mg/dL, AbA1C 5.7-6.4%) may see improvement in values post-intervention
1 secondary outcome
10 minute walk time
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. Data from human studies will be shared in aggregate and/or deidentified form at the time of publication and backed up on shared drives among the study personnel according to the terms of the Institutional Review Board and the approved consent forms. Identifying data will be kept in a locked cabinet under supervision of the PI and destroyed at the conclusion of the study
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.
Robert J Wessells, PhD contact
Robert J Wessells, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 minutes cycling exercise and Virtual Reality in people with Prolonged Inactivity and Metabolic Syndrome, run by Wayne State University 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyson Sujkowski, PhD (419-461-4317, asujkows@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose, HbA1C (time frame: 10 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 23 Dec 2025.