MedTrace Logo

Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD

NCT03462472 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-03-12

No results posted yet for this study

Summary

Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).

Conditions

  • Peripheral Arterial Disease

Interventions

BEHAVIORAL

Lower leg heating

Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius

BEHAVIORAL

Lower leg transcutaneous electrical nerve stimulation (TENS)

Bilateral lower leg transcutaneous electrical nerve stimulation (TENS) using burst mode at a 3Hz burst rate, 100Hz frequency, and 250 µs pulse duration, sufficient to evoke skeletal muscle contraction

Sponsors & Collaborators

  • Salisbury University

    lead OTHER

Principal Investigators

  • Thomas K. Pellinger, Ph.D. · Salisbury University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-15
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462472 on ClinicalTrials.gov