The Acute Effects of Leg Heating and Transcutaneous Electrical Nerve Stimulation on Leg Blood Flow and Functional Capacity in Those With Peripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Salisbury University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Distance walked during six-minute walk test
- Last Updated
- 8 years ago
Overview
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).
Investigators
Eligibility Criteria
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
- •Pregnant or breast feeding
Outcomes
Primary Outcomes
Distance walked during six-minute walk test
Time Frame: 35 minutes post-intervention/control
Distance walked during a self-paced six-minute walk
Secondary Outcomes
- Time/distance to claudication during six-minute walk(35 minutes following each intervention and control period)
- Ankle brachial index (ABI)(Pre-intervention baseline and 20 minutes post-intervention/control)
- Toe oxygen saturation(Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control)
- Popliteal artery blood flow(Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control)