ENhancing Exercise With LIGHT to Improve Functioning in PAD

ConditionsPeripheral Artery Disease Peripheral Vascular Disease Aging Walking, Difficulty

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorNorthwestern University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Above- or below-knee amputation

Critical limb ischemia defined as an ABI <0.40 with symptoms of rest pain

Wheelchair confinement or requiring a walker to ambulate

Walking is limited by a symptom other than PAD

Trial design

Design model

Parallel

Treatments tested in this trial

Far red light therapy
Device
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.
Sham light therapy
Device
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.
Home-based walking exercise
Behavioral
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.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Far red light therapy + home-based walking exerciseExperimental treatment 2 interventions

Group B: Sham therapy + home-based walking exerciseSham comparator 2 interventions

Trial outcomes

Primary outcomes

Six-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)

Secondary outcomes

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

Other outcomes

Walking Impairment Questionnaire Speed Score

Participant report of ability to walking increasing number of stair flights (0-100 score, 100-best)

Time frame

Measured at baseline and 4-month follow-up

Walking Impairment Questionnaire Stair Climbing Score

Participant report of ability to walking increasing number of stair flights (0-100 score, 100-best)

Time frame

Measured at baseline and 4-month follow-up

Short-Form 36 (SF-36) Score (0-100 score, 100-best)

Change in score on the SF-36 from baseline to follow-up

Time frame

Measured at baseline and 4-month follow-up

Short Physical Performance Battery (SPPB)

SPPB range, range 0-12, 12-best

Time frame

Measured at baseline and 4-month follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov

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