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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104944 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFO to improve outcomes | Experimental | Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum |
|
| Historical Controls | No Intervention | Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFO to improve outcomes | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
| 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). | 12 weeks |
| 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). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan J. Mays, PhD, MPH, MS | International Heart Institute of Montana Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Heart Institute of Montana Foundation | Missoula | Montana | 59802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30924412 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for more information about the sponsor | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AFO to Improve Outcomes | Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum |
| FG001 | Historical Controls | Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Scale units | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AFO to Improve Outcomes | Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Respiratory Problems | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Mays PhD, MPH, MS | University of Minnesota | 612-625-0430 | rjmays@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2015 | Jun 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| 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. |
| 12 weeks |
| 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. | 12 weeks |
| BG001 | Historical Controls | Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Historical Controls | Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention |
|
|
| 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). | Posted | Mean | Standard Deviation | Scale units | 12 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | percent of score | 12 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scale units | 12 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scale units | 12 weeks |
|
|
|
| 0 |
| 15 |
| 3 |
| 15 |
| 0 |
| 15 |
| EG001 | Historical Controls | Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention | 0 | 10 | 0 | 10 | 0 | 10 |
| End-stage COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Lower Limb Skin Infection | Infections and infestations | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |