Muscle Loss, Muscle Weakness, Older Adult, PreDiabetes
Conditions
Keywords
Virtual Exercise Intervention, Strength training, Older Adult, Prediabetes, Muscle strength, Small group training
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
Interventions
BEHAVIORALVivo
Participants will meet virtually twice a week with their small group and certified trainer for 45 minutes exercise sessions for a 12-week period.
Sponsors
Impactiv, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The PI will be masked to randomization assignment.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower body strength | baseline and 12 weeks | Lower body strength measured by the 30-second chair stand |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C (HbA1C) | baseline and 12 weeks | Hemoglobin A1C (HbA1C) measure during clinic assessment |
| Balance | baseline and 12 weeks | Static Balance Score of the SPPB. Sore 0-4 depending on the combined results of side by side, semi-tandem, and tandem stand tests. |
| Physical Activity Level | baseline and 12 weeks | Average step count using Garmin Fitness Tracker |
| Aerobic Endurance | baseline and 12 weeks | Measured by the 2-minute step test for aerobic endurance |
Countries
United States
Outcome results
None listed