Aging Clinical Trial - ENhancing Exercise With LIGHT to Improve

Status Recruiting

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06399900
Study type	Interventional
Source	Northwestern University
Contact	Mary McDermott, MD
Phone	13125036419
Email	mdm608@northwestern.edu
Status	Recruiting
Phase	N/A
Start date	June 1, 2024
Completion date	January 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Completed	`NCT05293730` - Trial of the Impact of the Electronic Frailty Integrated With Social Needs	N/A
Recruiting	`NCT03932162` - Gene Expression Changes In Young and Geriatric Skin	Early Phase 1
Completed	`NCT04064528` - Effects of Age on Amino Acid Delivery to Tendon	N/A
Completed	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT06029920` - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment	N/A
Recruiting	`NCT05543980` - Leg Heat Therapy in Elderly Individuals	Phase 2
Recruiting	`NCT05566938` - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly	N/A
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Not yet recruiting	`NCT06071130` - Emotion, Aging, and Decision Making	N/A
Enrolling by invitation	`NCT04641663` - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)	N/A
Completed	`NCT04088006` - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity	N/A
Completed	`NCT03695081` - Patient Pathway Pharmacist - Optimal Drug-related Care	N/A
Recruiting	`NCT05424263` - Acetate and Age-associated Arterial Dysfunction	Phase 2
Completed	`NCT05601713` - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling	N/A
Completed	`NCT04551339` - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19	N/A
Recruiting	`NCT04997577` - Speech Perception and High Cognitive Demand	N/A
Completed	`NCT05922475` - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training	N/A
Completed	`NCT04015479` - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ENhancing Exercise With LIGHT to Improve Functioning in PAD — ENLIGHTEN PAD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms