Peripheral Artery Disease
Conditions
Keywords
claudication, ankle foot orthoses, community walking exercise
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.
Interventions
DEVICEAFO to improve outcomes
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.
Sponsors
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in WIQ Distance Subscore | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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 | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AFO to Improve Outcomes open label, non-interventional design (all patients who volunteer for trial receive AFO)
AFO to improve outcomes: 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. | 15 |
| Historical Controls Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention | 10 |
| Total | 25 |
Baseline characteristics
| Characteristic | Historical Controls | Total | AFO to Improve Outcomes |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 12 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 13 Participants | 6 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 6.7 | 65.7 years STANDARD_DEVIATION 10.5 | 67.4 years STANDARD_DEVIATION 12.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 19 Participants | 14 Participants |
| Region of Enrollment United States | 10 participants | 25 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 10 |
| other Total, other adverse events | 0 / 15 | 0 / 10 |
| serious Total, serious adverse events | 3 / 15 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFO to Improve Outcomes | Change in SF-36 MCS | 4.3 Scale units | Standard Deviation 7.6 |
| Historical Controls | Change in SF-36 MCS | -1.1 Scale units | Standard Deviation 6 |
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFO to Improve Outcomes | Change in SF-36 PCS | 2.9 Scale units | Standard Deviation 5 |
| Historical Controls | Change in SF-36 PCS | 2.1 Scale units | Standard Deviation 6.7 |
Primary
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFO to Improve Outcomes | Change in WIQ Distance Subscore | 22.7 Scale units | Standard Deviation 24.5 |
| Historical Controls | Change in WIQ Distance Subscore | -7.2 Scale units | Standard Deviation 13.2 |
Primary
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFO to Improve Outcomes | Change in WIQ Speed Subscore | 14.9 Scale units | Standard Deviation 17.1 |
| Historical Controls | Change in WIQ Speed Subscore | -7.5 Scale units | Standard Deviation 19.6 |
Primary
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFO to Improve Outcomes | Change in WIQ Stair-Climbing Subscore | 18.9 percent of score | Standard Deviation 23.5 |
| Historical Controls | Change in WIQ Stair-Climbing Subscore | 0 percent of score | Standard Deviation 37.2 |