Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes

NCT05497960 | Completed Results DMC

• 2 other identifiers: Pro001100211R44AG076087-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This research trial studies the effect of an online, live and interactive strength training program on physical function and strength in older adults with prediabetes.

Conditions

PreDiabetes; Older Adults; Muscle Loss; Muscle Weakness

Keywords

older adults; pre diabetes; strength training; muscle weakness; resistance training; virtual; intervention

Outcome Measures

Primary Outcomes (5)

• Leg Strength Assessed Through a 30 Second Chair Rise Test

  Participants completed as many chair stands as they could in 30 seconds

  at 3 months (endpoint)

• Workout Attendance

  Attendance to each workout session was tallied. A possible 24 workout sessions were offered for the intervention (12 weeks of 2 days a week for workouts). The number of participants includes everyone who completed intervention, excluding those who stopped intervention at some point. The data reported represents the overall percent attendance of the participants that completed the intervention (N=22 participants). Attendance was calculated by averaging the number of sessions attended divided by the total number of exercise sessions attended (24 sessions).

  after each workout session for up to 3 months (endpoint)

• Intervention Engagement Assessed by Self- Reported Ease of Use

  Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree

  at 3 months (endpoint)

• Program Satisfaction

  Participants completed the question on a questionnaire to answer "What was your overall satisfaction with Vivo?" Responses are percentage of participant who reported being satisfied or very satisfied with the Vivo intervention. A higher number indicates higher satisfaction.

  at the 3 month (endpoint)

• Exercise Intervention Trainer Fidelity Checklist

  The exercise intervention fidelity as assessed at 4 time points over the course of the 12-week exercise program using a 9-item checklist to ensure unbiased assessment. The purpose was to observe the exercise session to see if the main areas of the intervention were being delivered; workout intensity, safety, and participation and engagement. The results below indicate the percentage of exercise workouts that met the 9-item checklist. A higher score indicates higher fidelity.

  over the course of the 12 week intervention

Other Outcomes (6)

• Health-related Quality of Life Measured Via the Short Form (SF)-36

  baseline and at 3 months (endpoint)

• Satisfaction With Life Measured by the 5 Item SWL Questionnaire

  3 months

• Profile of Mood Survey (POMS)

  baseline and at 3 months (endpoint)

Study Arms (1)

Vivo strength training

OTHER

Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.

Behavioral: Vivo workout

Interventions

Vivo workout BEHAVIORAL

2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer.

Vivo strength training

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;
• Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
• Ambulatory and community-dwelling
• Sedentary: less than 150 minutes of moderate physical activity OR less than 75 minutes of vigorous physical activity per week
• Have not engaged in resistance training for at least 6 months prior to enrollment
• Low functioning (defined as able to do at least 1 chair stand without using hand in 30 second but unable to meet the moderate function criteria for age and gender)
• Access to WiFi (or internet connection) in defined exercise space
• Willing to maintain weight and current diet throughout the study

You may not qualify if:

• Inability to complete physical function assessment or inability to do a chair stand without using hands.
• Use of antidiabetic medications
• Use of testosterone supplement or replacement
• Clinical disorder precluding/interfering with participation or assessments
• Unstable angina, arrhythmia, uncontrolled hypertension
• End Stage Renal Disease on Hemodialysis
• Lower extremity amputation or paralysis
• Neurological conditions causing functional or pronounced cognitive impairments
• Active malignancy except for non-melanomatous skin cancers
• Unable to provide consent
• Weight instability

Sponsors & Collaborators

• Eric Levian: lead
• Duke University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prediabetic State; Muscular Atrophy; Muscle Weakness; Glucose Intolerance

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; Hyperglycemia

Results Point of Contact

• Title: Eric Levitan
• Organization: IMPACTIV (Vivo)

eric@teamvivo.com

770-331-3208

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: September 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 15, 2023
• Last Updated: September 16, 2025
• Results First Posted: November 12, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)