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

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Behavioral: Lower leg heating; Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS)

• Registration Number: NCT03462472
• Lead Sponsor: Salisbury University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-15
• Study First Submitted: 2018-02-13
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-12
• Last Update Posted: 2018-03-12
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
15 minute lower leg heating	Lower leg heating	-
15 minute lower leg TENS	Lower leg transcutaneous electrical nerve stimulation (TENS)	-
45 minute lower leg TENS	Lower leg transcutaneous electrical nerve stimulation (TENS)	-
45 minute lower leg heating	Lower leg heating	-

Primary Outcome Measures

Name	Time	Method
Distance walked during six-minute walk test	35 minutes post-intervention/control	Distance walked during a self-paced six-minute walk

Secondary Outcome Measures

Name	Time	Method
Ankle brachial index (ABI)	Pre-intervention baseline and 20 minutes post-intervention/control	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
Toe oxygen saturation	Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control	A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet
Popliteal artery blood flow	Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control	Unilateral popliteal blood flow measured via Doppler ultrasound
Time/distance to claudication during six-minute walk	35 minutes following each intervention and control period	Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test

Trial Locations

Locations (1)

Salisbury University; 🇺🇸 Salisbury, Maryland, United States