Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399900
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-30
Brief Title:
ENhancing Exercise with LIGHT to Improve Functioning in PAD
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
ENhancing Exercise with LIGHT to Improve Functioning in PAD the ENLIGHTEN PAD Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ENLIGHTEN PAD
Brief Summary:
The ENLIGHTEN PAD Trial will collect preliminary data to test whether daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions improves six-minute walk distance at 4-month follow-up compared to sham light in people with lower extremity peripheral artery disease PAD
Detailed Description:
The ENLIGHTEN PAD Trial will collect preliminary data to test whether daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions improves six-minute walk distance at 4-month follow-up compared to sham light in people with lower extremity peripheral artery disease PAD Primary Aim 1 In Primary Aim 2 the investigators will measure the acute effect of the first treatment of 660 nm light on six-minute walk distance and on walking intensity measured with the ActiGraph accelerometer during the six-minute walk In secondary and exploratory aims the investigators will delineate biologic pathways by which 660 nm light enhances the benefits of home-based walking exercise by measuring the effects of 660 nm light on exercise intensity during the exercise intervention and by measuring the effects of 660 nm light on plasma nitrosothiols leg perfusion and gastrocnemius muscle health and mitochondrial activity Exercise intensity will be measured by the well validated ActiGraph accelerometer
The ENLIGHTEN PAD Trial is a Phase II multi-centered randomized clinical trial Thirty-two participants with PAD will be randomized at one of two centers Northwestern University PI MM McDermott MD and the University of Alabama PI Nicole Lohr MD PhD to either 660 nm light home-based exercise or sham light home-based exercise for four months Both groups of participants will receive the same home-based high intensity walking exercise intervention
The ENLIGHTEN PAD Trial is a Phase II multi-centered randomized clinical trial Thirty-two participants with PAD will be randomized at one of two centers Northwestern University PI MM McDermott MD and the University of Alabama PI Nicole Lohr MD PhD to either 660 nm light home-based exercise or sham light home-based exercise for four months Both groups of participants will receive the same home-based high intensity walking exercise intervention
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