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Ankle-foot Orthoses for Peripheral Artery Disease

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AFO to improve outcomes
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring claudication, ankle foot orthoses, community walking exercise

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD).
  • Patients who experience calf claudication
  • ≥40 years of age
  • An abnormal ankle-brachial index (ABI) of ≤.90.
  • For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI

Exclusion Criteria:

  • Lower extremity amputation(s) which interfere(s) with walking.
  • Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities).
  • Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis)
  • Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening.
  • Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure.
  • Myocardial infarction within 3 months prior to screening.
  • Acute coronary syndrome symptoms diagnosed at time of screening.
  • Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and >1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm).
  • Transient ischemic attack or stroke 3 months prior to screening.
  • New left bundle branch block or sustained ventricular tachycardia >30 seconds during screening.
  • Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening.
  • Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening.
  • Individuals currently incarcerated.
  • Evidence of acute impairment from alcohol or other illicit drugs.
  • Lack of diabetes control (glycated hemoglobin >12%)
  • Patients who are anemic (Hgb <11 g/dL for women and <10 g/dL for men).
  • Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.

Sites / Locations

  • International Heart Institute of Montana Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AFO to improve outcomes

Historical Controls

Arm Description

Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum

Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention

Outcomes

Primary Outcome Measures

Change in WIQ Distance Subscore
In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Change in WIQ Speed Subscore
In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Change in WIQ Stair-Climbing Subscore
In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Change in SF-36 PCS
Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Change in SF-36 MCS
Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2014
Last Updated
July 9, 2019
Sponsor
University of Minnesota
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02280200
Brief Title
Ankle-foot Orthoses for Peripheral Artery Disease
Official Title
Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).
Detailed Description
The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO. Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes. We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
claudication, ankle foot orthoses, community walking exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFO to improve outcomes
Arm Type
Experimental
Arm Description
Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum
Arm Title
Historical Controls
Arm Type
No Intervention
Arm Description
Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
Intervention Type
Device
Intervention Name(s)
AFO to improve outcomes
Intervention Description
Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.
Primary Outcome Measure Information:
Title
Change in WIQ Distance Subscore
Description
In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Time Frame
12 weeks
Title
Change in WIQ Speed Subscore
Description
In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Time Frame
12 weeks
Title
Change in WIQ Stair-Climbing Subscore
Description
In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Time Frame
12 weeks
Title
Change in SF-36 PCS
Description
Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Time Frame
12 weeks
Title
Change in SF-36 MCS
Description
Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD). Patients who experience calf claudication ≥40 years of age An abnormal ankle-brachial index (ABI) of ≤.90. For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI Exclusion Criteria: Lower extremity amputation(s) which interfere(s) with walking. Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities). Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis) Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening. Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure. Myocardial infarction within 3 months prior to screening. Acute coronary syndrome symptoms diagnosed at time of screening. Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and >1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm). Transient ischemic attack or stroke 3 months prior to screening. New left bundle branch block or sustained ventricular tachycardia >30 seconds during screening. Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening. Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening. Individuals currently incarcerated. Evidence of acute impairment from alcohol or other illicit drugs. Lack of diabetes control (glycated hemoglobin >12%) Patients who are anemic (Hgb <11 g/dL for women and <10 g/dL for men). Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan J. Mays, PhD, MPH, MS
Organizational Affiliation
International Heart Institute of Montana Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Heart Institute of Montana Foundation
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30924412
Citation
Mays RJ, Mays AA, Mizner RL. Efficacy of ankle-foot orthoses on walking ability in peripheral artery disease. Vasc Med. 2019 Aug;24(4):324-331. doi: 10.1177/1358863X19831765. Epub 2019 Mar 29.
Results Reference
derived
Links:
URL
http://ctrin.unlv.edu/
Description
Click here for more information about the sponsor

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Ankle-foot Orthoses for Peripheral Artery Disease

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