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Recruiting NCT07296991

VR Stimulation of Exercise Response in Sedentary Humans

No phase Interventional Prolonged Inactivity Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 20 minutes cycling exercise, Virtual Reality.
Who it may be relevant to
Registry conditions: Prolonged Inactivity, Metabolic Syndrome. Basic parameters: 25 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 20 minutes cycling exercise
    20 minutes cycling exercise
  • Behavioral Virtual Reality
    20 minutes virtual cycling

Primary outcome measures

  • Blood Glucose, HbA1C [Time frame: 10 weeks]
Secondary outcome measures (1)
  • 10 minute walk time [Time frame: 10 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wayne State University — Detroit

Identifiers

NCT: NCT07296991 · IRB-23-06-5927 · 5R01AG059683-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗