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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-15

Study Completion Date

2018-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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15 minute lower leg heating

Group Type EXPERIMENTAL

Lower leg heating

Intervention Type BEHAVIORAL

Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius

45 minute lower leg heating

Group Type EXPERIMENTAL

Lower leg heating

Intervention Type BEHAVIORAL

Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

15 minute lower leg TENS

Group Type EXPERIMENTAL

Lower leg transcutaneous electrical nerve stimulation (TENS)

Intervention Type BEHAVIORAL

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

45 minute lower leg TENS

Group Type EXPERIMENTAL

Lower leg transcutaneous electrical nerve stimulation (TENS)

Intervention Type BEHAVIORAL

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

Interventions

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Lower leg heating

Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No