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Ankle-foot Orthoses for Peripheral Artery Disease

9. juli 2019 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Montana
      • Missoula, Montana, Forenede Stater, 59802
        • International Heart Institute of Montana Foundation

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AFO to improve outcomes
Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum
Enhed: 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.
Ingen indgriben: Historical Controls
Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in WIQ Distance Subscore
Tidsramme: 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).
12 weeks
Change in WIQ Speed Subscore
Tidsramme: 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).
12 weeks
Change in WIQ Stair-Climbing Subscore
Tidsramme: 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).
12 weeks
Change in SF-36 PCS
Tidsramme: 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.
12 weeks
Change in SF-36 MCS
Tidsramme: 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.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Minnesota

Samarbejdspartnere

National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)

Efterforskere

  • Ledende efterforsker: Ryan J. Mays, PhD, MPH, MS, International Heart Institute of Montana Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2014

Primær færdiggørelse (Faktiske)

1. december 2017

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

28. oktober 2014

Først indsendt, der opfyldte QC-kriterier

28. oktober 2014

Først opslået (Skøn)

31. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Mays-2
  • U54GM104944 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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