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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06458530
Other study ID # Pro00110021_2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 31, 2024
Est. completion date July 31, 2025

Study information

Verified date June 2024
Source Impactiv, Inc.
Contact Recruiter
Phone 919-660-7507
Email VivoPrediabetes@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Vivo
Participants will meet virtually twice a week with their small group and certified trainer for 45 minutes exercise sessions for a 12-week period.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Impactiv, Inc. Duke University

Country where clinical trial is conducted

United States, 

Outcome

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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