ENhancing Exercise With LIGHT to Improve Functioning in PAD

NCT06399900 | Recruiting

• 1 other identifier: STU00219103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peripheral Artery Disease; Aging; Peripheral Vascular Disease; Walking, Difficulty

Keywords

light therapy; peripheral artery disease; exercise

Outcome Measures

Primary Outcomes (2)

• Six-Minute Walk Distance

  Change in six-minute walk distance

  Measured at baseline and 4-month follow-up

• Six-Minute Walk Distance

  Change in six-minute walk distance (acute effect)

  Measured immediately after the first light treatment (within 15 minutes after the first treatment, acute effect)

Secondary Outcomes (7)

• Six-Minute Walk Distance

  Measured at 4-month follow-up, 24 hours after the final treatment

• Gastrocnemius Perfusion

  Measured at baseline and 4-month follow-up

• Minutes of High Intensity Exercise

  Measured at baseline and 4-month follow-up

• Mean Exercise Intensity

  Measured at baseline and 4-month follow-up

• Mean Exercise Intensity During Six-Minute Walk

  Measured at baseline and 4-month follow-up

Other Outcomes (14)

• Walking Impairment Questionnaire Speed Score

  Measured at baseline and 4-month follow-up

• Walking Impairment Questionnaire Stair Climbing Score

  Measured at baseline and 4-month follow-up

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

  Measured at baseline and 4-month follow-up

Study Arms (2)

Far red light therapy + home-based walking exercise

EXPERIMENTAL

Subgroup of participants receiving home-based walking exercise and the 670 nm far red light device

Device: Far red light therapy; Behavioral: Home-based walking exercise

Sham therapy + home-based walking exercise

SHAM COMPARATOR

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.

Device: Sham light therapy; Behavioral: Home-based walking exercise

Interventions

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.

Far red light therapy + home-based walking exercise

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.

Sham therapy + home-based walking exercise

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.

Far red light therapy + home-based walking exercise; Sham therapy + home-based walking exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Mobility Limitation; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Mary McDermott, MD

CONTACT

13125036419; mdm608@northwestern.edu

Kathryn Domanchuk

CONTACT

312-503-6438; kdomanchuk@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This will be a double blinded study where both the participant and the people collecting data will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeremiah Stamler Professor of Medicine

Model Details: Thirty-two participants with PAD will be randomized to either 660 nm light + home-based exercise or sham light + home-based exercise for four months. Both groups will receive the same home-based high intensity walking exercise intervention.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)