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

Sponsor

Eric Levian (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05497960

Collaborator

Duke University (Other)

Enrollment

Location

Arm

8.4

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes Older Adults Muscle Loss Muscle Weakness	Behavioral: Vivo workout	N/A

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 panedmic, 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 demonstrate efficacy 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.

To do so, the investigators will conduct a clinical trial to determine the effectiveness of Vivo verses a wait list control on glucose control, physical function, social engagement, adherence and quality of life in hopes of preventing the progression from prediabetes to Type 2 diabetes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

May 15, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Intervention engagement assess by workout attendance older adults with prediabetes [3 months]
workout attendance will be measured, reasons for missed workouts will be collected participation; b) ease of use; and c) overall satisfaction. Milestone 2: Assess trainer fidelity
Intervention engagement assessed by self- reported barriers and facilitators [3 months]
Participants will complete questions to answer their comfort level with using the technology platform functional specifications of the client-centered approach (results, goals, adherence, upcoming workouts), and social engagement and support. Milestone 2: Develop a clickable prototype of the platform.
Program satisfaction [3 months]
Participants will complete a questionnaire to answer "how satisfied are you with the program"

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 60 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