Clinical trial NCT06458530: Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.
Official title: Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Older Adult
Muscle Loss
Muscle Weakness
Keywords: Virtual Exercise Intervention
Strength training
Older Adult
Prediabetes
Muscle strength
Small group training
Lead sponsor: Impactiv, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2024-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

Detailed description: This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Ambulatory and community-dwelling
* Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
* Low functioning: 1) able to do at least 1 chair stand and 2) number of chair stands done in 30 seconds is below criterion-referenced fitness standards for maintaining physical independence for age and gender
* 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
* Access to WiFi in defined exercise space

Exclusion Criteria:

* Inability to complete physical function assessment
* Use of antidiabetic medications
* Use of testosterone supplement or replacement
* Clinical disorder precluding/interfering with participation of assessments

  * Unstable angina, arrhythmia, uncontrolled hypertension
  * End Stage Renal Disease on Hemodialysis
  * Lower extremity amputation or paralysis
  * Neurological condition causing functional or pronounced cognitive impairments
  * Active malignancy except for non-melanomatous skin cancers
* Weight instability (defined as gain or loss of ≥10% over the last 6 months)
* Unable to provide consent

Primary outcomes:
measure: Lower body strength
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Hemoglobin A1C (HbA1C)
timeFrame: baseline and 12 weeks
measure: Balance
timeFrame: baseline and 12 weeks
measure: Physical Activity Level
timeFrame: baseline and 12 weeks
measure: Aerobic Endurance
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: