Ankle-foot Orthoses for Peripheral Artery Disease
9. juli 2019 oppdatert av: University of Minnesota
Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I
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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
31
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Montana
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Missoula, Montana, Forente stater, 59802
- International Heart Institute of Montana Foundation
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: AFO to improve outcomes
Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum
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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.
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Ingen inngripen: Historical Controls
Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in WIQ Distance Subscore
Tidsramme: 12 weeks
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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).
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12 weeks
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Change in WIQ Speed Subscore
Tidsramme: 12 weeks
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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).
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12 weeks
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Change in WIQ Stair-Climbing Subscore
Tidsramme: 12 weeks
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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).
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12 weeks
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Change in SF-36 PCS
Tidsramme: 12 weeks
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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.
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12 weeks
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Change in SF-36 MCS
Tidsramme: 12 weeks
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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.
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12 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ryan J. Mays, PhD, MPH, MS, International Heart Institute of Montana Foundation
Publikasjoner og nyttige lenker
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Generelle publikasjoner
Hjelpsomme linker
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. november 2014
Primær fullføring (Faktiske)
1. desember 2017
Studiet fullført (Faktiske)
1. desember 2017
Datoer for studieregistrering
Først innsendt
28. oktober 2014
Først innsendt som oppfylte QC-kriteriene
28. oktober 2014
Først lagt ut (Anslag)
31. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Mays-2
- U54GM104944 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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