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

The Acute Effects of Leg Heating and Transcutaneous Electrical Nerve Stimulation on Leg Blood Flow and Functional Capacity in Those With Peripheral Arterial Disease

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).

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Lower leg heating; Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Salisbury, Maryland, United States, 21801
      • Recruiting
      • Salisbury University
      • Contact: Tom Pellinger, Ph.D.; Phone Number: 410-677-0144; Email: tkpellinger@salisbury.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Intermittent claudication (Fontaine Stage II)
• Resting ankle-brachial index (ABI) < 0.90
• Ability to walk > 60 meters in six minutes

Exclusion Criteria:

• Body mass index (BMI) > 35 kg/m2
• Severe exercise limitations (more than PAD) due to co-morbidity
• Taking illegal/recreational drugs
• Uncontrolled hypertension (>180/100 mmHg)
• Severe peripheral neuropathy
• Foot ulcers
• Gangrene
• Pregnant or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 15 minute lower leg heating	Behavioral: Lower leg heating; Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
Experimental: 45 minute lower leg heating	Behavioral: Lower leg heating; Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
Experimental: 15 minute lower leg TENS	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
Experimental: 45 minute lower leg TENS	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked during six-minute walk test	Distance walked during a self-paced six-minute walk	35 minutes post-intervention/control

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Popliteal artery blood flow	Unilateral popliteal blood flow measured via Doppler ultrasound	Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Time/distance to claudication during six-minute walk	Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test	35 minutes following each intervention and control period
Ankle brachial index (ABI)	Systolic blood pressures (SBP) are measured in the brachial arteries of both arms and in the posterior tibial and dorsalis pedis arteries of both ankles using a hand-held Doppler ultrasound probe and a sphygmomanometer	Pre-intervention baseline and 20 minutes post-intervention/control
Toe oxygen saturation	A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet	Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control

Collaborators and Investigators

• Sponsor: Salisbury University
• Investigators: Principal Investigator: Thomas K. Pellinger, Ph.D., Salisbury University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 11112015-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No