Examining the effects of Vivo on physical function and glycemic levels in older adults with prediabetes
Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
This study is testing if a virtual strength training program can help older adults with prediabetes improve their leg strength and blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Impactiv, Inc. Industry-sponsored |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06458530 on ClinicalTrials.gov |
What this trial studies
This 12-week randomized controlled trial investigates the impact of the Vivo intervention on lower extremity strength and average glycemic levels in sedentary older adults diagnosed with prediabetes. Participants will be randomly assigned to either the Vivo intervention group, which involves virtual strength training sessions twice a week, or a waitlist control group. The primary outcomes will be measured through the number of chair stands completed in 30 seconds and changes in HbA1c levels. The study aims to enroll up to 90 individuals aged 60 and older who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are sedentary individuals aged 60 and older with a recent diagnosis of prediabetes and low physical function.
Not a fit: Patients who are currently using antidiabetic medications or have significant clinical disorders that interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve physical function and glycemic control in older adults with prediabetes, potentially reducing their risk of developing type 2 diabetes.
How similar studies have performed: Other studies have shown positive outcomes with virtual exercise interventions in older adults, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 60 years * Ambulatory and community-dwelling * Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4% * Low functioning: 1) able to do at least 1 chair stand and 2) number of chair stands done in 30 seconds is below criterion-referenced fitness standards for maintaining physical independence for age and gender * Sedentary: less than 150 minutes of moderate physical activity OR less than 60 minutes of vigorous physical activity per week * Have not engaged in resistance training for at least 6 months prior to enrollment * Access to WiFi in defined exercise space Exclusion Criteria: * Inability to complete physical function assessment * Use of antidiabetic medications * Use of testosterone supplement or replacement * Clinical disorder precluding/interfering with participation of assessments * Unstable angina, arrhythmia, uncontrolled hypertension * End Stage Renal Disease on Hemodialysis * Lower extremity amputation or paralysis * Neurological condition causing functional or pronounced cognitive impairments * Active malignancy except for non-melanomatous skin cancers * Weight instability (defined as gain or loss of ≥10% over the last 6 months) * Unable to provide consent
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Recruiter
- Email: VivoPrediabetes@duke.edu
- Phone: 919-660-7507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.