Trial Outcomes & Findings for Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes (NCT NCT05497960)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

at 3 months (endpoint)

Results posted on

2025-09-16

Participant Flow

Participants were recruited from electronic medical records in Duke Maestro Care as described in the Clinical Trials Information. All participants who enrolled and were eligible for the trial participated in the feasibility study.

Participant milestones

Participant milestones
Measure	Vivo Intervention Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills
Overall Study STARTED	28
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivo Strength Training n=22 Participants 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.
Age, Continuous	68.9 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Leg strength assessed through a 30 second chair rise test	12.1 chair stands STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: at 3 months (endpoint)

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

Outcome measures

Outcome measures
Measure	Vivo Strength Training n=22 Participants Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. 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.
Leg Strength Assessed Through a 30 Second Chair Rise Test	14.2 number of chair stands Standard Deviation 2.9

PRIMARY outcome

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

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Vivo Strength Training n=24 exercise sessions Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. 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.
Workout Attendance	85 percent of attendance Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: at 3 months (endpoint)

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

Outcome measures

Outcome measures
Measure	Vivo Strength Training n=22 Participants Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. 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 Engagement Assessed by Self- Reported Ease of Use Easy to sign into class	82 percent of participants
Intervention Engagement Assessed by Self- Reported Ease of Use Easy to follow workout instructions during class	86 percent of participants
Intervention Engagement Assessed by Self- Reported Ease of Use Level system made it easy to tailor intensity and exercises to my abilities	95 percent of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vivo Strength Training n=22 Participants Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. 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.
Program Satisfaction	95 percent of participants

PRIMARY outcome

Timeframe: over the course of the 12 week intervention

Population: There were 4 exercise cohorts in this feasibility study, taught by different trainers. To ensure exercise fidelity across the cohorts, 4 exercise sessions from each cohort were observed for a total of 16 observed exercise sessions. A 9-item checklist was used to ensure components of the sessions were being met. The 16 sessions met 96% of the checklist components.

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.

Outcome measures

Outcome measures
Measure	Vivo Strength Training n=16 exercise sessions Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. 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.
Exercise Intervention Trainer Fidelity Checklist	96 percentage of workouts meeting checklist

Adverse Events

Vivo Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vivo Intervention n=22 participants at risk Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills
Infections and infestations COVID infection	4.5% 1/22 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Back pain following a skiing accident	4.5% 1/22 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Shoulder pain following exercise	4.5% 1/22 • Number of events 1 • 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.

Additional Information

Eric Levitan

IMPACTIV (Vivo)

Phone: 770-331-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place