PreDiabetesNCT06458530
Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.
A study testing Vivo in people with PreDiabetes and Older Adult, run by Impactiv, Inc. at 1 site in United States.
Trial 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. 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 Adult, Muscle Loss
- What is being tested?
- Vivo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
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.
Read the detailed description
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. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments
- Conditions
- PreDiabetes, Older Adult, Muscle Loss, Muscle Weakness
- Being tested
- Vivo
- Keywords
- Virtual Exercise Intervention, Strength training, Older Adult, Prediabetes, Muscle strength, Small group training
- Medical subject headings
- Prediabetic State, Muscular Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivoBehavioural
Participants will meet virtually twice a week with their small group and certified trainer for 45 minutes exercise sessions for a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Vivo intervention | Experimental | Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower body strength
Lower body strength measured by the 30-second chair stand
Measured: baseline and 12 weeks
Secondary outcomes (4)
Hemoglobin A1C (HbA1C)
Hemoglobin A1C (HbA1C) measure during clinic assessment
Measured: baseline and 12 weeks
Balance
Static Balance Score of the SPPB. Sore 0-4 depending on the combined results of side by side, semi-tandem, and tandem stand tests.
Measured: baseline and 12 weeks
Physical Activity Level
Average step count using Garmin Fitness Tracker
Measured: baseline and 12 weeks
Aerobic Endurance
Measured by the 2-minute step test for aerobic endurance
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start9 Jul 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impactiv, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Eric Levian, Impactiv, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458530
- Sponsor's protocol ID
- Pro00110021_2
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
- ClinicalTrials.gov ID
- NCT06458530
- Acronym / sponsor ID
- Pro00110021_2
- Conditions
- PreDiabetes, Older Adult, Muscle Loss, Muscle Weakness
- Keywords
- Virtual Exercise Intervention, Strength training, Older Adult, Prediabetes, Muscle strength, Small group training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Impactiv, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivo intervention | Experimental | Behavioral: VivoParticipants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- Inability to complete physical function assessment
- Use of antidiabetic medications
- Use of testosterone supplement or replacement
- Clinical disorder precluding/interfering with participation of assessments
- Weight instability (defined as gain or loss of ≥10% over the last 6 months)
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 |
|---|---|---|
| VivoParticipants will meet virtually twice a week with their small group and certified trainer for 45 minutes exercise sessions for a 12-week period. | Behavioural | Vivo intervention |
Primary outcome
Lower body strength
Time frame: baseline and 12 weeks
Lower body strength measured by the 30-second chair stand
4 secondary outcomes
Hemoglobin A1C (HbA1C)
Time frame: baseline and 12 weeks
Balance
Time frame: baseline and 12 weeks
Physical Activity Level
Time frame: baseline and 12 weeks
Aerobic Endurance
Time frame: baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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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 in people with PreDiabetes and Older Adult, run by Impactiv, Inc. 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 7 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 22 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lower body strength (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.