- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296991
VR Stimulation of Exercise Response in Sedentary Humans
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alyson Sujkowski, PhD
- Phone Number: 419-461-4317
- Email: asujkows@med.wayne.edu
Study Contact Backup
- Name: Robert J Wessells, PhD
- Phone Number: 7344764325
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Wayne State University
-
Contact:
- Alyson Sujkowski, PhD
- Phone Number: 419-461-4317
- Email: asujkows@med.wayne.edu
-
Contact:
- Robert J Wessells, PhD
- Phone Number: 734-476-4325
- Email: rwessell@med.wayne.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: EX-20 minutes sub max cycling exercise
20 minutes cycling exercise
|
20 minutes cycling exercise
|
|
Experimental: VR-virtual reality exercise
20 minutes virtual cycling
|
20 minutes virtual cycling
|
|
Active Comparator: VR+: 20 minutes sub max cycling exercise + virtual reality
20 minutes cycling exercise + 20 minutes virtual cycling
|
20 minutes cycling exercise
20 minutes virtual cycling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10 minute walk time
Time Frame: 10 weeks
|
distance walked in 10 minutes is recorded pre- and post- intervention and may improve
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert J Wessells, PhD, Wayne State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-23-06-5927
- 5R01AG059683-07 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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