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

Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; PreDiabetes; Muscle Loss; Older Adult
• Intervention / Treatment: Behavioral: Vivo

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivo intervention; Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes.	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.
No Intervention: Waitlist control; Participants randomized to this arm will be asked to maintain their baseline physical activity for 12-weeks. They will be scheduled for the baseline and 12-week assessment and following the 12-week assessment, they will be offered enrollment into Vivo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower body strength	Lower body strength measured by the 30-second chair stand	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C (HbA1C)	Hemoglobin A1C (HbA1C) measure during clinic assessment	baseline and 12 weeks
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
Physical Activity Level	Average step count using Garmin Fitness Tracker	baseline and 12 weeks
Aerobic Endurance	Measured by the 2-minute step test for aerobic endurance	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Impactiv, Inc.
• Collaborators: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prediabetes; Muscle strength; Strength training; Older Adult; Virtual Exercise Intervention; Small group training
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Muscle Weakness; Muscular Atrophy; Prediabetic State
• Other Study ID Numbers: Pro00110021_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No