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

E

Eric Levian

Status

Completed

Conditions

Muscle Weakness
Older Adults
Muscle Loss
PreDiabetes

Treatments

Behavioral: Vivo workout

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT05497960
1R44AG076087-01 (U.S. NIH Grant/Contract)
Pro00110021

Details and patient eligibility

About

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.

Full 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 pandemic, 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 test feasibility 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.

In the next study, Phase II NCT06458530, investigators will examine the effects of Vivo on physical function and glycemic level in sedentary older with prediabetes

Enrollment

28 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts 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 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Vivo strength training
Other group
Description:
Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout.
Treatment:
Behavioral: Vivo workout

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Alyssa King

Data sourced from clinicaltrials.gov

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