Clinical trial NCT06399900: ENhancing Exercise with LIGHT to Improve Functioning in PAD
Official title: ENhancing Exercise with LIGHT to Improve Functioning in PAD: the ENLIGHTEN PAD Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Aging
Walking, Difficulty
Keywords: light therapy
peripheral artery disease
exercise
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed 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 aims, the investigators will delineate biologic pathways by which 660 nm light enhances the benefits of home-based walking exercise, by measuring the effects of 660 nm light on exercise intensity during the exercise intervention and by measuring the effects of 660 nm light on plasma nitrosothiols, leg perfusion, and gastrocnemius muscle health and mitochondrial activity. Exercise intensity will be measured by the well validated ActiGraph accelerometer.

The ENLIGHTEN PAD Trial is a Phase II multi-centered randomized clinical trial. Thirty-two participants with PAD will be randomized at one of two centers: Northwestern University (PI: MM McDermott, MD) and the University of Alabama (PI: Nicole Lohr MD, PhD) to either 660 nm light + home-based exercise or sham light + home-based exercise for four months. Both groups of participants will receive the same home-based high intensity walking exercise intervention.

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 \<0.30 or \<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.

Primary outcomes:
measure: Six-Minute Walk Distance
timeFrame: Measured at baseline and 4-month follow-up
measure: Six-Minute Walk Distance
timeFrame: Measured immediately after the first light treatment (within 15 minutes after the first treatment, acute effect)
Secondary outcomes:
measure: Six-Minute Walk Distance
timeFrame: Measured at 4-month follow-up, 24 hours after the final treatment
measure: Gastrocnemius Perfusion
timeFrame: Measured at baseline and 4-month follow-up
measure: Minutes of High Intensity Exercise
timeFrame: Measured at baseline and 4-month follow-up
measure: Mean Exercise Intensity
timeFrame: Measured at baseline and 4-month follow-up
measure: Mean Exercise Intensity During Six-Minute Walk
timeFrame: Measured at baseline and 4-month follow-up
measure: Walking Impairment Questionnaire Distance Score
timeFrame: Measured at baseline and 4-month follow-up
measure: PROMIS Mobility Score
timeFrame: Measured at baseline and 4-month follow-up
Other outcomes:
measure: Walking Impairment Questionnaire Speed Score
timeFrame: Measured at baseline and 4-month follow-up
measure: Walking Impairment Questionnaire Stair Climbing Score
timeFrame: Measured at baseline and 4-month follow-up
measure: Short-Form 36 (SF-36) Score (0-100 score, 100-best)
timeFrame: Measured at baseline and 4-month follow-up
measure: Short Physical Performance Battery (SPPB)
timeFrame: Measured at baseline and 4-month follow-up
measure: Plasma Nitrite
timeFrame: Measured before and within five minutes after the first light treatment at baseline
measure: Plasma Nitrite
timeFrame: Measured before and within five minutes after the final light treatment at 4-month follow-up
measure: Plasma Nitrosothiols
timeFrame: Measured before and within five minutes after the first light treatment at baseline
measure: Plasma Nitrosothiols
timeFrame: Measured before and within five minutes after the final light treatment at 4-month follow-up
measure: Gastrocnemius Muscle Capillary Density
timeFrame: Measured at baseline and 4-month follow-up
measure: Gastrocnemius Muscle Myofiber Size
timeFrame: Measured at baseline and 4-month follow-up
measure: Gastrocnemius Muscle Citrate Synthase Activity
timeFrame: Measured at baseline and 4-month follow-up
measure: Gastrocnemius Muscle Cytochrome C Oxidase Activity
timeFrame: Measured at baseline and 4-month follow-up
measure: Gastrocnemius Muscle Abundance of Satellite Cells
timeFrame: Measured at baseline and 4-month follow-up
measure: Gastrocnemius Muscle Abundance of Myofibers with Central Nuclei
timeFrame: Measured at baseline and 4-month follow-up
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: