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

NCT06458530 | Completed DMC

• 1 other identifier: Pro00110021_2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Older Adult; Muscle Loss; Muscle Weakness

Keywords

Virtual Exercise Intervention; Strength training; Older Adult; Prediabetes; Muscle strength; Small group training

Outcome Measures

Primary Outcomes (1)

• Lower body strength

  Lower body strength measured by the 30-second chair stand

  baseline and 12 weeks

Secondary Outcomes (4)

• Hemoglobin A1C (HbA1C)

  baseline and 12 weeks

• Balance

  baseline and 12 weeks

• Physical Activity Level

  baseline and 12 weeks

• Aerobic Endurance

  baseline and 12 weeks

Study Arms (2)

Vivo intervention

EXPERIMENTAL

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

Behavioral: Vivo

Waitlist control

NO INTERVENTION

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.

Interventions

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.

Vivo intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Impactiv, Inc.: lead
• Duke University: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prediabetic State; Muscular Atrophy; Muscle Weakness

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The PI will be masked to randomization assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: July 9, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)