ENhancing Exercise With LIGHT to Improve Functioning in PAD

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06399900
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Aug 12, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Far red light therapy + home-based walking exercise
    Subgroup of participants receiving home-based walking exercise and the 670 nm far red light device
  • Sham Comparator: Sham therapy + home-based walking exercise
    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.

Primary Outcome Measure

Six-Minute Walk Distance [ Time Frame: Measured at baseline and 4-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Mary McDermott, MD
[email protected]
312-503-6419

Find similar trials in Chicago, IL

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
Northwestern University· Chicago, IL

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