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

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower leg heating
Lower leg transcutaneous electrical nerve stimulation (TENS)
Sponsored by
Salisbury University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Arterial Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Salisbury UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

No Intervention

Experimental

Experimental

Arm Label

15 minute lower leg heating

45 minute lower leg heating

Control

15 minute lower leg TENS

45 minute lower leg TENS

Arm Description

Outcomes

Primary Outcome Measures

Distance walked during six-minute walk test
Distance walked during a self-paced six-minute walk

Secondary Outcome Measures

Popliteal artery blood flow
Unilateral popliteal blood flow measured via Doppler ultrasound
Time/distance to claudication during six-minute walk
Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test
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
Toe oxygen saturation
A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet

Full Information

First Posted
February 13, 2018
Last Updated
March 5, 2018
Sponsor
Salisbury University
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1. Study Identification

Unique Protocol Identification Number
NCT03462472
Brief Title
Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2015 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salisbury University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
15 minute lower leg heating
Arm Type
Experimental
Arm Title
45 minute lower leg heating
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Title
15 minute lower leg TENS
Arm Type
Experimental
Arm Title
45 minute lower leg TENS
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lower leg heating
Intervention Description
Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
Intervention Type
Behavioral
Intervention Name(s)
Lower leg transcutaneous electrical nerve stimulation (TENS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Distance walked during six-minute walk test
Description
Distance walked during a self-paced six-minute walk
Time Frame
35 minutes post-intervention/control
Secondary Outcome Measure Information:
Title
Popliteal artery blood flow
Description
Unilateral popliteal blood flow measured via Doppler ultrasound
Time Frame
Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Title
Time/distance to claudication during six-minute walk
Description
Subjects give subjective ratings of claudication onset, if applicable, during six-minute walk test
Time Frame
35 minutes following each intervention and control period
Title
Ankle brachial index (ABI)
Description
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
Time Frame
Pre-intervention baseline and 20 minutes post-intervention/control
Title
Toe oxygen saturation
Description
A pulse oximeter is used to measure toe oxygen saturation in the big toe of each of the subject's feet
Time Frame
Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 Gangrene Pregnant or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Pellinger, Ph.D.
Phone
410-677-0144
Email
tkpellinger@salisbury.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas K. Pellinger, Ph.D.
Organizational Affiliation
Salisbury University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salisbury University
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Pellinger, Ph.D.
Phone
410-677-0144
Email
tkpellinger@salisbury.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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