PreDiabetesNCT05497960

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

A study testing Vivo workout in people with PreDiabetes and Older Adults, run by Eric Levian at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: PreDiabetes, Older Adults, Muscle Loss
What is being tested?: Vivo workout
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2022to 15 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Vivo workout
Keywords: older adults, pre diabetes, strength training, muscle weakness, resistance training, virtual, intervention
Medical subject headings: Prediabetic State, Muscular Atrophy, Muscle Weakness, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vivo workoutBehavioural
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.

Study groups in NCT05497960
Study group	Role	What they receive
Vivo strength training	Other	Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. Receives: Behavioral: Vivo workout

What is being measured

The primary outcome is the main question the study is designed to answer.

Leg Strength Assessed Through a 30 Second Chair Rise Test
Participants completed as many chair stands as they could in 30 seconds
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: over the course of the 12 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202215 May 2023

First posted11 Aug 2022
Study start1 Sep 2022
Primary completion31 Mar 2023
Study completion15 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PreDiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05497960
Sponsor's protocol ID: Pro00110021
Other IDs: 1R44AG076087-01
Status last verified: Sep 2025
First submitted: 8 Aug 2022
Last updated: 16 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Feasibility and Acceptability of Vivo, an Online, Live and Interactive Strength Training Program, in Sedentary Older Adults With Prediabetes.
ClinicalTrials.gov ID: NCT05497960
Acronym / sponsor ID: Pro00110021
Conditions: PreDiabetes, Older Adults, Muscle Loss, Muscle Weakness
Keywords: older adults, pre diabetes, strength training, muscle weakness, resistance training, virtual, intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eric LevianIndustry (pharma, biotech, devices)
Collaborators: Duke University, National Institute on Aging (NIA)
Study start: 1 Sep 2022 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 15 May 2023 (actual)
First posted: 11 Aug 2022 (actual)
Results: Posted 12 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vivo strength training	Other	Behavioral: Vivo workoutParticipants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age ≥ 60 years;

Key exclusion criteria (11 listed)

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
Unable to provide consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vivo workout2 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.	Behavioural	Vivo strength training

Primary outcome

Leg Strength Assessed Through a 30 Second Chair Rise Test
Time frame: at 3 months (endpoint)
Participants completed as many chair stands as they could in 30 seconds
Workout Attendance
Time frame: after each workout session for up to 3 months (endpoint)
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).
Intervention Engagement Assessed by Self- Reported Ease of Use
Time frame: at 3 months (endpoint)
Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree
Program Satisfaction
Time frame: at the 3 month (endpoint)
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.
Exercise Intervention Trainer Fidelity Checklist
Time frame: over the course of the 12 week intervention
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.

Results and safety

Results posted to the registry on 12 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vivo Intervention	28	22

Primary outcome: Leg Strength Assessed Through a 30 Second Chair Rise Test

Time frame: at 3 months (endpoint). Mean (Standard Deviation). Unit: number of chair stands

Measure	Vivo Strength Training n = 22
Value	14.2 (2.9)

Primary outcome: Workout Attendance

Time frame: after each workout session for up to 3 months (endpoint). Mean (Full Range). Unit: percent of attendance

Measure	Vivo Strength Training n = 22
Value	85 (0 to 100)

Population analysed: 22 participants completed the intervention. Each participant had the opportunity to attend 24 exercise sessions. The attendance rate was calculated based on the number of sessions the participant attended divided by the total possible sessions (24 sessions). The attendance rate was then averaged across the participants who completed the intervention.

Primary outcome: Intervention Engagement Assessed by Self- Reported Ease of Use

Time frame: at 3 months (endpoint). Number. Unit: percent of participants

Measure	Vivo Strength Training n = 22
Easy to sign into class	82
Easy to follow workout instructions during class	86
Level system made it easy to tailor intensity and exercises to my abilities	95

Primary outcome: Program Satisfaction

Time frame: at the 3 month (endpoint). Number. Unit: percent of participants

Measure	Vivo Strength Training n = 22
Value	95

Adverse events

Time frame: Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 12 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vivo Intervention	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for PreDiabetes

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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vivo workout in people with PreDiabetes and Older Adults, run by Eric Levian at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leg Strength Assessed Through a 30 Second Chair Rise Test (time frame: at 3 months (endpoint)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.