RECRUITING

ENhancing Exercise with LIGHT to Improve Functioning in PAD

Conditions

Peripheral Artery Disease Peripheral Vascular Disease Aging Walking, Difficulty light therapy exercise

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-08-12

Study Completion:2027-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06399900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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.

Inclusion Criteria

Exclusion Criteria

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.

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.

Contacts and Locations

Study Contact

Mary McDermott, MD

CONTACT

13125036419

mdm608@northwestern.edu

Kathryn Domanchuk

CONTACT

312-503-6438

kdomanchuk@northwestern.edu

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12

Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-08-12

Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

light therapy
peripheral artery disease
exercise

Additional Relevant MeSH Terms

Peripheral Artery Disease
Peripheral Vascular Disease
Aging
Walking, Difficulty