ENhancing Exercise With LIGHT to Improve Functioning in PAD: the ENLIGHTEN PAD Trial
Northwestern University
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).
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…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as: 1. An ABI \<= 0.90 at baseline. 2. 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. 3. 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. Exclusion Criteria: 1. Above- or below-knee amputation 2. Critical limb…
Interventions
- DeviceFar red light therapy
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.
- DeviceSham light therapy
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.
- BehavioralHome-based walking exercise
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.
Location
- Northwestern UniversityChicago, Illinois