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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03462472
• Other study ID #: 11112015-2
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2018
• Last updated: March 5, 2018
• Start date: November 15, 2015
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Salisbury University
• Contact: Tom Pellinger, Ph.D.
• Phone: 410-677-0144
• Email: tkpellinger[@]salisbury.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Lower leg heating
Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
• 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

Locations

Country	Name	City	State
United States	Salisbury University	Salisbury	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Salisbury University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked during six-minute walk test	Distance walked during a self-paced six-minute walk	35 minutes post-intervention/control
Secondary	Popliteal artery blood flow	Unilateral popliteal blood flow measured via Doppler ultrasound	Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Secondary	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
Secondary	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
Secondary	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