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

Not Applicable

Recruiting

• Conditions: Muscle Loss; PreDiabetes; Muscle Weakness; Older Adult
• Interventions: Behavioral: Vivo

• Registration Number: NCT06458530
• Lead Sponsor: Impactiv, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-13
• Status Verified: 2024-07
• Study Start: 2024-07-09
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vivo intervention	Vivo	Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes.

Primary Outcome Measures

Name	Time	Method
Lower body strength	baseline and 12 weeks	Lower body strength measured by the 30-second chair stand

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States