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

Salisbury University

Status: Unknown

Conditions: Peripheral Arterial Disease

Treatments: Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS); Behavioral: Lower leg heating

Study type: Interventional

Funder types: Other

Identifiers

NCT03462472

11112015-2

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

10 participants in 5 patient groups

15 minute lower leg heating

Experimental group

Treatment:

Behavioral: Lower leg heating

45 minute lower leg heating

Experimental group

Treatment:

Behavioral: Lower leg heating

Control

No Intervention group

15 minute lower leg TENS

Experimental group

Treatment:

Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS)

45 minute lower leg TENS

Experimental group

Treatment:

Behavioral: Lower leg transcutaneous electrical nerve stimulation (TENS)