ENhancing Exercise with LIGHT to Improve Functioning in PAD: the ENLIGHTEN PAD Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

⁃ First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as:

• An ABI \<= 0.90 at baseline.

• Vascular lab evidence of PAD (such as a toe brachial pressure \< 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.

• An ABI of \>0.90 and \<= 1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Mary McDermott, MD
mdm608@northwestern.edu
13125036419
Backup
Kathryn Domanchuk
kdomanchuk@northwestern.edu
312-503-6438
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 32
Treatments
Experimental: Far red light therapy + home-based walking exercise
Subgroup of participants receiving home-based walking exercise and the 670 nm far red light device
Sham_comparator: Sham therapy + home-based walking exercise
Subgroup of participants receiving home-based walking exercise and the sham light device, far red light device covered with blue filter paper to block 670 nm light, resulting in mean power generated of 0.24 mW/cm2, compared to 26.3 mW/cm2 for the intervention, a 100-fold difference.
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov