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

NCT ID: NCT05497960

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-05-15

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.

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

Conditions

PreDiabetes; Older Adults; Muscle Loss; Muscle Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vivo strength training

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

Group Type: OTHER

Vivo workout

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Eric Levian

INDUSTRY

Sponsor Role: lead

Responsible Party

Eric Levian

CEO

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R44AG076087-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00110021

Identifier Type: -

Identifier Source: org_study_id