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

Evaluating the Feasibility and Acceptability of Vivo, an Online, Live and Interactive Strength Training Program, in Sedentary Older Adults With Prediabetes.

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; PreDiabetes; Older Adults; Muscle Loss
• Intervention / Treatment: Behavioral: Vivo workout

Detailed Description

It is well established that in-person resistance training is an effective form of exercise to increase physical function and quality of life amongst adults. However, older adults report not participating in resistance training due to lack of age appropriate programs, fear of a gym setting, poor access to a gym, joint and other kinds of pain, and lack of social support. These barriers have been compounded as a result of COVID-19 pandemic, wherein older adults are encouraged to socially isolate, leading to even less physical activity. Vivo is a virtual small group exercise program designed for adults 55 and addresses these major barriers to strength training by coaching through an interactive online training session incorporating social support and social engagement.

The investigators plan is to test a highly attractive technology platform specifically designed to meet the needs of older adults to demonstrate that resistance training exercise can be scaled and effective with diverse older adults and remove the barrier of having to go to a gym setting to see benefits. The investigators will test feasibility in a real world sample of adults ≥60 with prediabetes, a very prevalent, serious and often silent health condition that affects 1 in 3 adults in the US and is associated with high rates of sarcopenia, or loss of muscle mass.

In the next study, Phase II NCT06458530, investigators will examine the effects of Vivo on physical function and glycemic level in sedentary older with prediabetes

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vivo strength training; Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.	Behavioral: Vivo workout; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep measured via the Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality)	3 months
Leg strength assessed through a 30 second chair rise test	Participants will complete as many chair stands as they can in 30 seconds	3 months
Health-related quality of life measured via the Short Form (SF)-36	Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life)	3 months
Satisfaction with Life measured by the 5 item SWL questionnaire	Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)	3 months
Exercise Efficacy	Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors	3 months
Profile of Mood Survey (POMS)	Changes from baseline to 3 months will assess participant's changes in mood.	3 months
Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)	Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life Measured Via the Short Form (SF)-36	Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life)	baseline and at 3 months (endpoint)
Satisfaction With Life Measured by the 5 Item SWL Questionnaire	Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)	3 months
Profile of Mood Survey (POMS)	Changes from baseline to 3 months will assess participant's changes in mood.	baseline and at 3 months (endpoint)
Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)	Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress	baseline and at 3 months (endpoint)
Exercise Efficacy	Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors	baseline and at 3 months (endpoint)
Sleep Measured Via the Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality)	baseline and at 3 months (endpoint)

Collaborators and Investigators

• Sponsor: Eric Levian
• Collaborators: Duke University; National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: muscle weakness; older adults; strength training; intervention; virtual; resistance training; pre diabetes
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Atrophy; Hyperglycemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Muscle Weakness; Muscular Atrophy; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: Pro00110021; 1R44AG076087-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No