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

NCT ID: NCT06458530

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2026-03-31

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

Conditions

PreDiabetes; Older Adult; Muscle Loss; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Vivo intervention

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

Group Type: EXPERIMENTAL

Vivo

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Impactiv, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Eric Levian

CEO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00110021_2

Identifier Type: -

Identifier Source: org_study_id