PreDiabetes Clinical Trial
Official title:
Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
Verified date | June 2024 |
Source | Impactiv, Inc. |
Contact | Recruiter |
Phone | 919-660-7507 |
VivoPrediabetes[@]duke.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Impactiv, Inc. | Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower body strength | Lower body strength measured by the 30-second chair stand | baseline and 12 weeks | |
Secondary | Hemoglobin A1C (HbA1C) | Hemoglobin A1C (HbA1C) measure during clinic assessment | baseline and 12 weeks | |
Secondary | Balance | Static Balance Score of the SPPB. Sore 0-4 depending on the combined results of side by side, semi-tandem, and tandem stand tests. | baseline and 12 weeks | |
Secondary | Physical Activity Level | Average step count using Garmin Fitness Tracker | baseline and 12 weeks | |
Secondary | Aerobic Endurance | Measured by the 2-minute step test for aerobic endurance | baseline and 12 weeks |
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