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

Primary Purpose

PreDiabetes, Older Adults, Muscle Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivo workout
Sponsored by
Eric Levian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring older adults, pre diabetes, strength training, muscle weakness, resistance training, virtual, intervention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vivo strength training

Arm Description

Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.

Outcomes

Primary Outcome Measures

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
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.
Program satisfaction
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
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
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)
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
Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)
Exercise Efficacy
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)
Changes from baseline to 3 months will assess participant's changes in mood.
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

Full Information

First Posted
August 8, 2022
Last Updated
July 28, 2023
Sponsor
Eric Levian
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05497960
Brief Title
Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes
Official Title
Evaluating the Feasibility and Acceptability of Vivo, an Online, Live and Interactive Strength Training Program, in Sedentary Older Adults With Prediabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Levian
Collaborators
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Older Adults, Muscle Loss, Muscle Weakness
Keywords
older adults, pre diabetes, strength training, muscle weakness, resistance training, virtual, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivo strength training
Arm Type
Other
Arm Description
Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.
Intervention Type
Behavioral
Intervention Name(s)
Vivo workout
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention engagement assess by workout attendance older adults with prediabetes
Description
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
Time Frame
3 months
Title
Intervention engagement assessed by self- reported barriers and facilitators
Description
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.
Time Frame
3 months
Title
Program satisfaction
Description
Participants will complete a questionnaire to answer "how satisfied are you with the program"
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Leg strength assessed through a 30 second chair rise test
Description
Participants will complete as many chair stands as they can in 30 seconds
Time Frame
3 months
Title
Health-related quality of life measured via the Short Form (SF)-36
Description
Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life)
Time Frame
3 months
Title
Sleep measured via the Pittsburgh Sleep Quality Index (PSQI)
Description
Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality)
Time Frame
3 months
Title
Satisfaction with Life measured by the 5 item SWL questionnaire
Description
Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL)
Time Frame
3 months
Title
Exercise Efficacy
Description
Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors
Time Frame
3 months
Title
Profile of Mood Survey (POMS)
Description
Changes from baseline to 3 months will assess participant's changes in mood.
Time Frame
3 months
Title
Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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