Clinical trial NCT05497960: 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
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Older Adults
Muscle Loss
Muscle Weakness
Keywords: older adults
pre diabetes
strength training
muscle weakness
resistance training
virtual
intervention
Lead sponsor: Impactiv, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: National Institute on Aging (NIA)
First posted: 2022-08-11
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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

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

Primary outcomes:
measure: Leg Strength Assessed Through a 30 Second Chair Rise Test
timeFrame: at 3 months (endpoint)
measure: Workout Attendance
timeFrame: after each workout session for up to 3 months (endpoint)
measure: Intervention Engagement Assessed by Self- Reported Ease of Use
timeFrame: at 3 months (endpoint)
measure: Program Satisfaction
timeFrame: at the 3 month (endpoint)
measure: Exercise Intervention Trainer Fidelity Checklist
timeFrame: over the course of the 12 week intervention
Secondary outcomes:
Other outcomes:
measure: Health-related Quality of Life Measured Via the Short Form (SF)-36
timeFrame: baseline and at 3 months (endpoint)
measure: Satisfaction With Life Measured by the 5 Item SWL Questionnaire
timeFrame: 3 months
measure: Profile of Mood Survey (POMS)
timeFrame: baseline and at 3 months (endpoint)
measure: Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: baseline and at 3 months (endpoint)
measure: Exercise Efficacy
timeFrame: baseline and at 3 months (endpoint)
measure: Sleep Measured Via the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline and at 3 months (endpoint)
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: