RecruitingNot ApplicableNCT06399900

ENhancing Exercise with LIGHT to Improve Functioning in PAD

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

Sponsor

Northwestern University

Enrollment

32 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

Aging Walking, Difficulty Peripheral Artery Disease Peripheral Vascular Disease

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

Min Age: 50 Years

Inclusion Criteria4

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.

Exclusion Criteria18

Above- or below-knee amputation
Critical limb ischemia defined as an ABI \<0.30 or \<0.40 with symptoms of rest pain
Wheelchair confinement or requiring a walker to ambulate
Walking is limited by a symptom other than PAD
Current foot ulcer on bottom of foot
Failure to successfully complete the study run-in
Planned major surgery, coronary or leg revascularization during the next four months
Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent, unless the cancer is located in the lower extremities. Participants who require oxygen only at night may still qualify.\]
Mini-Mental Status Examination (MMSE) score \< 23
Non-English speaking
Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
Visual impairment that limits walking ability.
Six-minute walk distance of \<400 feet or \>1700 feet.
Participation in a supervised treadmill exercise program or a cardiac rehabilitation program in previous three months or planning to begin a supervised treadmill exercise program or a cardiac rehabilitation program in the next five months.
Unwilling to avoid red light therapy outside of study participation.
Baseline blood pressure \<100/45.
In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.

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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.