Using light therapy to enhance walking in patients with peripheral artery disease

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

This study is testing if daily light therapy can help people with peripheral artery disease walk farther and improve their overall health when combined with home exercises.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06399900 on ClinicalTrials.gov

What this trial studies

The ENLIGHTEN PAD Trial aims to evaluate the effectiveness of daily 660 nm light treatment applied to the lower extremities before home-based walking exercises in improving walking distance for individuals with peripheral artery disease (PAD). This Phase II multi-centered randomized clinical trial will compare the outcomes of participants receiving light therapy against those receiving sham light therapy over a four-month period. The study will also investigate the immediate effects of the light treatment on walking intensity and explore biological mechanisms that may enhance exercise benefits. Participants will be monitored for changes in walking distance and other health indicators related to muscle and vascular function.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older who have been diagnosed with peripheral artery disease.

Not a fit: Patients with critical limb ischemia, amputations, or other conditions severely limiting mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking ability and overall quality of life for patients with peripheral artery disease.

How similar studies have performed: While the use of light therapy in this context is relatively novel, preliminary studies have shown promise in enhancing exercise outcomes in similar patient populations.

Eligibility criteria

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 ischemia defined as an ABI \<0.40 with symptoms of rest pain
3. Wheelchair confinement or requiring a walker to ambulate
4. Walking is limited by a symptom other than PAD
5. Current foot ulcer on bottom of foot
6. Failure to successfully complete the study run-in
7. Planned major surgery, coronary or leg revascularization during the next four months
8. Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
9. 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. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent, unless the cancer is located in the lower extremities. Participants who require oxygen only at night may still qualify.\]
10. Mini-Mental Status Examination (MMSE) score \< 23
11. Non-English speaking
12. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
13. Visual impairment that limits walking ability.
14. Six-minute walk distance of \<400 feet or \>1700 feet.
15. 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.
16. Unwilling to avoid red light therapy outside of study participation.
17. Baseline blood pressure \<100/45.
18. 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.

Where this trial is running

Chicago, Illinois

• Northwestern University — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Mary McDermott, MD

Conditions Peripheral Artery Disease; Peripheral Vascular Disease; Aging; Walking, Difficulty; light therapy; peripheral artery disease; exercise