Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458530
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-10
Brief Title:
Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
Sponsor:
Impactiv Inc
Organization:
Impactiv Inc
Study Overview
Official Title:
Vivo Prediabetes Study Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None