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Completed

NCT Number: NCT06458530

Examining the Effects of 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vivo

Behavioral

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

Primary outcomes

  1. Lower body strength

    Time frame: baseline and 12 weeks

    Lower body strength measured by the 30-second chair stand

Secondary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: baseline and 12 weeks

    Hemoglobin A1C (HbA1C) measure during clinic assessment

  2. Balance

    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.

  3. Physical Activity Level

    Time frame: baseline and 12 weeks

    Average step count using Garmin Fitness Tracker

  4. Aerobic Endurance

    Time frame: baseline and 12 weeks

    Measured by the 2-minute step test for aerobic endurance

Sponsors and collaborators

Lead sponsor

Impactiv, Inc.

Industry

Collaborators

  • Duke University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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