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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497960
• Other study ID #: Pro00110021
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: July 2023
• Source: Impactiv, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 15, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Muscle Loss
• Muscle Weakness
• Older Adults
• Paresis
• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eric Levian	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention engagement assess by workout attendance older adults with prediabetes	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	3 months
Primary	Intervention engagement assessed by self- reported barriers and facilitators	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.	3 months
Primary	Program satisfaction	Participants will complete a questionnaire to answer "how satisfied are you with the program"	3 months
Secondary	Leg strength assessed through a 30 second chair rise test	Participants will complete as many chair stands as they can in 30 seconds	3 months
Secondary	Health-related quality of life measured via the Short Form (SF)-36	Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life)	3 months
Secondary	Sleep measured via the Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality)	3 months
Secondary	Satisfaction with Life measured by the 5 item SWL questionnaire	Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)	3 months
Secondary	Exercise Efficacy	Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors	3 months
Secondary	Profile of Mood Survey (POMS)	Changes from baseline to 3 months will assess participant's changes in mood.	3 months
Secondary	Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)	Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress	3 months