Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT06458530
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
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. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will meet virtually twice a week with their small group and certified trainer for 45 minutes exercise sessions for a 12-week period.
Time frame: baseline and 12 weeks
Lower body strength measured by the 30-second chair stand
Time frame: baseline and 12 weeks
Hemoglobin A1C (HbA1C) measure during clinic assessment
Time frame: baseline and 12 weeks
Static Balance Score of the SPPB. Sore 0-4 depending on the combined results of side by side, semi-tandem, and tandem stand tests.
Time frame: baseline and 12 weeks
Average step count using Garmin Fitness Tracker
Time frame: baseline and 12 weeks
Measured by the 2-minute step test for aerobic endurance
Impactiv, Inc.
Industry
Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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