Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458530
• Other study ID #: Pro00110021_2
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Muscle Loss
• Muscle Weakness
• Older Adult
• PreDiabetes
• Prediabetic State

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