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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
All participants will receive one far red light device per leg. Participants will be asked to use their two light devices daily, exposing their bare legs to the devices for 10 minutes twice per day. An unblinded study coordinator will deliver the light devices to each participant's home, positioning the devices 15 cm behind the participant's heels, using tape on the floor to mark where the light and feet should be positioned. Twice each day, the participant flips a switch on the device to begin each session. A timer will turn off the device after 10 minutes. A power meter will measure the total time that the device was turned on. Participants will also record use of the light in a log.
All participants will receive one sham device per leg. Participants will be asked to use their two light devices daily, exposing their bare legs to the devices for 10 minutes twice per day. An unblinded study coordinator will deliver the light devices to each participant's home, positioning the devices 15 cm behind the participant's heels, using tape on the floor to mark where the light and feet should be positioned. Twice each day, the participant flips a switch on the device to begin each session. A timer will turn off the device after 10 minutes. A power meter will measure the total time that the device was turned on. Participants will also record use of the light in a log.
Northwestern University
Chicago, Illinois, United States
RECRUITINGSix-Minute Walk Distance
Change in six-minute walk distance
Time frame: Measured at baseline and 4-month follow-up
Six-Minute Walk Distance
Change in six-minute walk distance (acute effect)
Time frame: Measured immediately after the first light treatment (within 15 minutes after the first treatment, acute effect)
Six-Minute Walk Distance
Change in six-minute walk distance (chronic effect)
Time frame: Measured at 4-month follow-up, 24 hours after the final treatment
Gastrocnemius Perfusion
Changes in calf perfusion at 3 Tesla measured with arterial spin labeling with MRI and post-cuff occlusion hyperemia
Time frame: Measured at baseline and 4-month follow-up
Minutes of High Intensity Exercise
Change in minutes of high intensity exercise/week (measured by the ActiGraph activity monitor)
Time frame: Measured at baseline and 4-month follow-up
Mean Exercise Intensity
Change in mean exercise intensity (measured by the ActiGraph activity monitor)
Time frame: Measured at baseline and 4-month follow-up
Mean Exercise Intensity During Six-Minute Walk
Change in mean exercise intensity during the six-minute walk (measured by the ActiGraph activity monitor)
Time frame: Measured at baseline and 4-month follow-up
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This study involves a 16 week intervention where participants will walk at home for exercise with guidance from a study coach. Participants will have 4 in-person visits in the first four weeks and then have weekly phone calls in the last 12 weeks of the intervention with their coach.
Walking Impairment Questionnaire Distance Score
Participant report of difficulty walking increasingly longer distances. Score range 0-100, 100 is best
Time frame: Measured at baseline and 4-month follow-up
PROMIS Mobility Score
PROMIS mobility score from administered PROMIS questionnaire. Score range is from zero to infinity and a higher score means a better outcome.
Time frame: Measured at baseline and 4-month follow-up