Prehabilitering og rehabilitering i PAD (PREPARE-IT)
19. august 2024 oppdatert av: Jonathan Myers, Palo Alto Veterans Institute for Research
Prehabilitering og rehabilitering i PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)
For å bestemme effektiviteten av pre- og postoperativ treningsterapi hos pasienter som gjennomgår perifer arteriestenting for perifer arteriell sykdom.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Perifer arteriesykdom (PAD) er en form for kardiovaskulær sykdom som påvirker arteriene som leverer blodstrømmen til bena. Prevalensen av PAD øker raskt i USA. Når PAD er alvorlig, kan det forårsake smerte ved bevegelse og begrense en persons evne til å gå eller utføre sine vanlige daglige aktiviteter. Ved alvorlig PAD utføres ofte en prosedyre der en arterie holdes åpen med et lite rør kalt en stent.
Programmer for treningsbasert rehabilitering har vist seg å hjelpe disse pasientene i stor grad når det gjelder smertene de opplever ved å gå, deres evne til å utføre daglige aktiviteter eller de som kreves av arbeidet, og forbedret livskvalitet. Det finnes også en nyere form for terapi, kalt prehabilitering, som har vist seg å ha viktige fordeler for pasienter med PAD. Prehabilitering innebærer fire til seks uker med treningsterapi og livsstilsanbefalinger før man gjennomgår en stentprosedyre. Prehabilitering hjelper pasienter med å forbedre treningstoleransen og gjøre livsstilsendringer som forbedrer risikofaktorene før prosedyren. De som deltar i prehabiliteringsopplegg har færre komplikasjoner med stentprosedyren, tilbringer færre dager på sykehus og har bedre evne til å trene og komme raskere tilbake i arbeid.
Selv om fordelene med prehabilitering og rehabilitering er godt etablert, unnlater de fleste leger å anbefale disse behandlingene til sine pasienter som gjennomgår en stentprosedyre for PAD. Forskergruppen skal studere effekten av prehabilitering, rehabilitering eller begge terapiformene. Resultatene vil sannsynligvis oppmuntre flere leger til å anbefale det beste alternativet for sine pasienter, og muligens å anbefale både prehabilitering og rehabilitering blant pasienter som har en stentprosedyre.
Studietype
Intervensjonell
Registrering (Antatt)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jonathan N Myers, PhD
- Telefonnummer: 64661 650-493-5000
- E-post: drj993@aol.com
Studer Kontakt Backup
- Navn: Charles G Gronau, DCEP
- Telefonnummer: 618-746-69565
- E-post: gronauc92@gmail.com
Studiesteder
-
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California
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Palo Alto, California, Forente stater, 94304
- Rekruttering
- VA Palo Alto Health Care System
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Ta kontakt med:
- Jonathan N Myers, PhD
- Telefonnummer: 64661 650-493-5000
- E-post: drj993@aol.com
-
Ta kontakt med:
- Charles G Gronau, DCEP
- Telefonnummer: 618-746-6956
- E-post: gronauc92@gmail.com
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Hovedetterforsker:
- Jonathan N Myers, PhD
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Underetterforsker:
- Charles G Gronau, DCEP
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Underetterforsker:
- Khin N Chan, MD
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Underetterforsker:
- Pallavi Gautam, MPT
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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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inkluderingskriterier:
- Mannlig eller kvinnelig voksen diagnostisert med perifer arteriesykdom (PAD)
- Opplever bensmerter mens du går
- Planlagt å ha en stent for PAD
- Kan utføre trening trygt
- Postmenopausal og ikke av bæreevne
Ekskluderingskriterier:
- Medisinsk ustabile pasienter
- Nylig MI innen 3 måneder
- Malignitet
- Ukontrollert diabetes mellitus (HBA1C ≥8 mmol/l)
- Alkoholisme eller annen rekreasjonsbruk av rusmidler
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Prehabilitering
Forsøkspersoner som er randomisert til prehabiliteringsgruppen vil gjennomgå 6 uker med individualisert treningsterapi, inkludert en 1-ukes opptrappingsperiode (3 økter) utført på VAPAHCS-rehabiliteringsinstitusjonen.
Forsøkspersonene vil da først og fremst trene hjemme, med en treningsøkt på klinikken som gjentas ukentlig så lenge de deltar.
Disse øktene vil være individualiserte basert på toleranse og i henhold til standardiserte retningslinjer, men vil generelt bestå av 45-60 minutter med veiledet trening som kombinerer aerobic og motstandstrening, inkludert oppvarming og nedkjøling.
Gjennom hele studien vil forsøkspersonene bli bedt om å utføre 30 minutter med daglig uovervåket aerobic trening etter eget valg, med vekt på å forbedre gangytelsen hjemme.
Retningslinjer for pasientovervåking, sikkerhet og resepter skissert av American Heart Association, American College Sports Medicine og American Association of Cardiovascular and Pulmonary Rehabilitation vil bli fulgt.
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Aerobic og motstandstrening vil være en del av prehabiliterings- og rehabiliteringsprogrammene.
Gitt tilstedeværelsen av PAD, vil det legges spesiell vekt på volum av gange og forbedring av gangytelsen.
Andre navn:
Prehabiliterings- og rehabiliteringsprogrammene inkluderer alle kjernekomponenter av rehabilitering som skissert i retningslinjer.
Det gjeldende kliniske VAPAHCS-programmet inkluderer røykeslutt, ernæring, risikofaktorhåndtering og henvisninger til psykososial rådgivning etter behov, og disse tjenestene vil være tilgjengelige for det gjeldende forslaget.
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Aktiv komparator: Rehabilitering
Forsøkspersoner som er randomisert til rehabiliteringsgruppen vil starte treningsøkter ca. 2 uker etter endovaskulær intervensjon som beskrevet i retningslinjer for PAD.
Pasientstabilitet og såråpenthet vil være avgjørende hensyn før en pasient begynner på rehabiliteringsprogrammet.
I likhet med prehabilitering vil forsøkspersonene gjennomgå en 1-ukers, 3-sesjons familiariseringsperiode utført ved VAPAHCS-rehabiliteringsinstitusjonen, og deretter returnere en gang ukentlig for klinikkveilede økter.
De ukentlige personlige besøkene vil bli gjennomført på rehabiliteringssenteret for å overvåke og oppmuntre til etterlevelse, gjennomgå aktivitetsspørreskjemaer, laste ned akselerometridata og adressere eventuelle kliniske bekymringer.
I likhet med deltakere i prehabiliteringsgruppen vil den 6 uker lange rehabiliteringsperioden være individualisert og følge standardiserte retningslinjer designet for rehabilitering hos pasienter med PAD.
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Aerobic og motstandstrening vil være en del av prehabiliterings- og rehabiliteringsprogrammene.
Gitt tilstedeværelsen av PAD, vil det legges spesiell vekt på volum av gange og forbedring av gangytelsen.
Andre navn:
Prehabiliterings- og rehabiliteringsprogrammene inkluderer alle kjernekomponenter av rehabilitering som skissert i retningslinjer.
Det gjeldende kliniske VAPAHCS-programmet inkluderer røykeslutt, ernæring, risikofaktorhåndtering og henvisninger til psykososial rådgivning etter behov, og disse tjenestene vil være tilgjengelige for det gjeldende forslaget.
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Eksperimentell: Prehabilitering og rehabilitering
Forsøkspersoner som er randomisert til prehabiliterings- og rehabiliteringsgruppen vil gjennomgå både 6 ukers prehabilitering preoperativt og 6 ukers rehabilitering postoperativt som beskrevet i deres respektive armbeskrivelser.
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Aerobic og motstandstrening vil være en del av prehabiliterings- og rehabiliteringsprogrammene.
Gitt tilstedeværelsen av PAD, vil det legges spesiell vekt på volum av gange og forbedring av gangytelsen.
Andre navn:
Prehabiliterings- og rehabiliteringsprogrammene inkluderer alle kjernekomponenter av rehabilitering som skissert i retningslinjer.
Det gjeldende kliniske VAPAHCS-programmet inkluderer røykeslutt, ernæring, risikofaktorhåndtering og henvisninger til psykososial rådgivning etter behov, og disse tjenestene vil være tilgjengelige for det gjeldende forslaget.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tid til claudicatio smerte
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Tid til første debut av claudicatio-smerter med tredemølletest.
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Baseline, 6 uker, 14 uker, 22 uker
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Topp VO2
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Topp V02 vil bli bestemt på en tredemølle ved hjelp av en individualisert rampeprotokoll med innsamling av kontinuerlige respiratoriske gassutvekslingsresponser.
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Baseline, 6 uker, 14 uker, 22 uker
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6-minutters gangtest (6MWT)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Total avstand (meter) gange på 6 minutter.
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Baseline, 6 uker, 14 uker, 22 uker
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Walking impairment Questionnaire (WIQ)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Utviklet for å evaluere gangbegrensninger hos pasienter med PAD.
Vurderer individers evne til å gå definerte avstander og hastigheter og gå i trapper.
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Baseline, 6 uker, 14 uker, 22 uker
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Peripheral Artery Questionnaire (PAQ)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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20-elements spørreskjema utviklet og validert spesielt for PAD og er designet for å kvantifisere pasienters fysiske begrensninger, symptomer, sosial funksjon, behandlingstilfredshet og livskvalitet.
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Baseline, 6 uker, 14 uker, 22 uker
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Går
Tidsramme: Inntil 22 uker
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Fysiske aktivitetsmønstre, uttrykt som skritt/dag, vil kvantifiseres ved hjelp av trenings-/helsesporingsutstyr.
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Inntil 22 uker
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Energiforbruk
Tidsramme: Inntil 22 uker
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Energiforbruk vil bli kvantifisert ved hjelp av trenings-/helsesporingsapparat.
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Inntil 22 uker
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Stolen heves
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Antall repetisjoner fullført innen 60 sekunder (46 cm høyt sete).
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Baseline, 6 uker, 14 uker, 22 uker
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Overkroppsstyrke
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Maks 1 repetisjon for brystpress.
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Baseline, 6 uker, 14 uker, 22 uker
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Styrke i underkroppen
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Maks 1 repetisjon for Leg Extension.
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Baseline, 6 uker, 14 uker, 22 uker
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Håndgrepsstyrke
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Maksimal isometrisk styrke vil bli målt med et håndgrepsdynamometer.
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Baseline, 6 uker, 14 uker, 22 uker
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Insulinfølsomhet
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Fastende glukose- og insulinprøver vil bli tatt fra blodprøver for å generere homeostasemodellvurdering av insulinresistens (HOMA-IR)-score.
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Baseline, 6 uker, 14 uker, 22 uker
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Lipidpanel
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Fastende totalkolesterol, LDL, HDL og triglyserider vil bli vurdert fra blodprøvetaking.
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Baseline, 6 uker, 14 uker, 22 uker
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Natrium
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Standard Chem 20 blodprøvetaking vil bli brukt for å oppnå natrium i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Homocystein
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Homocystein vil bli vurdert fra blodprøvetaking.
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Baseline, 6 uker, 14 uker, 22 uker
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Høyfølsomt C-reaktivt protein (hs-CRP)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Høysensitivt C-reaktivt protein (hs-CRP) vil bli vurdert fra blodprøvetaking.
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Baseline, 6 uker, 14 uker, 22 uker
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Interleukin-6 (IL-6)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Interleukin-6 (IL-6) vil bli vurdert fra blodprøvetaking.
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Baseline, 6 uker, 14 uker, 22 uker
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D-dimer
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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D-dimer vil bli vurdert fra blodprøvetaking.
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Baseline, 6 uker, 14 uker, 22 uker
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Blodprotein
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøven vil bli brukt for å få blodproteinverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Albumin
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøve vil bli brukt for å få albumin i blodverdi.
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Baseline, 6 uker, 14 uker, 22 uker
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Kalsium
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøver vil bli brukt for å få kalsium i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Kalium
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøver vil bli brukt for å få kalium i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Klorid
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøvetaking vil bli brukt for å få klorid i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Karbondioksid
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøven vil bli brukt for å få karbondioksid i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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AST/GOTU/l
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøvetaking vil bli brukt for å få AST/GOTU/l i blodverdi.
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Baseline, 6 uker, 14 uker, 22 uker
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ALT/GPT
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøve vil bli brukt for å få ALT/GPT i blodverdi.
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Baseline, 6 uker, 14 uker, 22 uker
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ALK fosfatase
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøve vil bli brukt for å få ALT/GPT i blodverdi.
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Baseline, 6 uker, 14 uker, 22 uker
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Bilirubin
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøver vil bli brukt for å oppnå total bilirubin i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Urea nitrogen
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøvetaking vil bli brukt for å oppnå ureanitrogen i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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Kreatinin
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøver vil bli brukt for å få kreatinin i blodverdien.
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Baseline, 6 uker, 14 uker, 22 uker
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eGFR
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Blodprøvetaking vil bli brukt for å oppnå eGFR-verdi.
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Baseline, 6 uker, 14 uker, 22 uker
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endotelfunksjon
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Endo Pat 2000-systemet vil bli brukt til å utføre denne prosedyren.
Begge underarmene vil være okkludert med en standard blodtrykksmansjett i 5 minutter.
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Baseline, 6 uker, 14 uker, 22 uker
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Ankel-brachial indeks (ABI)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Bruk av en standard brachial arterie mansjettmetode med en doppler ultralydsonde ved den bakre tibialis arterie for å bestemme ABI.
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Baseline, 6 uker, 14 uker, 22 uker
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Exercise Benefits and Barrier Scale (EBBS)
Tidsramme: Baseline, 6 uker, 14 uker, 22 uker
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Opplevde barrierer og fordeler for fysisk aktivitet vil bli vurdert ved hjelp av to metoder: et semistrukturert intervju og administrasjon av Exercise Benefits and Barriers Scale (EBBS), for å få både åpne kvalitative og kvantitative data om disse konstruksjonene.
EBBS kan brukes i sin helhet eller som to separate skalaer.
Som helhet varierer poengsummen for EBBS fra 43 til 172, og en høyere poengsum er at individet oppfatter treningen mer positivt.
Når fordelsskalaen brukes alene, er poengsummen mellom 29 og 116, og jo høyere poengsum er den enkelte oppfatter treningen mer positivt.
Når barriereskalaen brukes alene, er poengsummen mellom 14 og 56.
Jo høyere poengsum på Barriers Scale, jo større oppfatning av barrierer for trening.
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Baseline, 6 uker, 14 uker, 22 uker
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006 Mar 21;47(6):1239-312. doi: 10.1016/j.jacc.2005.10.009. No abstract available.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
- Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
- Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
- Sechrist KR, Walker SN, Pender NJ. Development and psychometric evaluation of the exercise benefits/barriers scale. Res Nurs Health. 1987 Dec;10(6):357-65. doi: 10.1002/nur.4770100603.
- Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
- Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
- Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.
- Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C. Erratum In: Circulation. 2005 Apr 5;111(13):1717.
- McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599.
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- Pande RL, Perlstein TS, Beckman JA, Creager MA. Association of insulin resistance and inflammation with peripheral arterial disease: the National Health and Nutrition Examination Survey, 1999 to 2004. Circulation. 2008 Jul 1;118(1):33-41. doi: 10.1161/CIRCULATIONAHA.107.721878. Epub 2008 Jun 16.
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- Saetre T, Enoksen E, Lyberg T, Stranden E, Jorgensen JJ, Sundhagen JO, Hisdal J. Supervised exercise training reduces plasma levels of the endothelial inflammatory markers E-selectin and ICAM-I in patients with peripheral arterial disease. Angiology. 2011 May;62(4):301-5. doi: 10.1177/0003319710385338.
- McDermott MM, Liu K, Ferrucci L, Tian L, Guralnik JM, Green D, Tan J, Liao Y, Pearce WH, Schneider JR, McCue K, Ridker P, Rifai N, Criqui MH. Circulating blood markers and functional impairment in peripheral arterial disease. J Am Geriatr Soc. 2008 Aug;56(8):1504-10. doi: 10.1111/j.1532-5415.2008.01797.x. Epub 2008 Jul 24.
- Woo KS, Chook P, Lolin YI, Cheung AS, Chan LT, Sun YY, Sanderson JE, Metreweli C, Celermajer DS. Hyperhomocyst(e)inemia is a risk factor for arterial endothelial dysfunction in humans. Circulation. 1997 Oct 21;96(8):2542-4. doi: 10.1161/01.cir.96.8.2542.
- Abdellaoui A, Al-Khaffaf H. C-reactive protein (CRP) as a marker in peripheral vascular disease. Eur J Vasc Endovasc Surg. 2007 Jul;34(1):18-22. doi: 10.1016/j.ejvs.2006.10.040. Epub 2007 Feb 12.
- Collins TC, Lunos S, Carlson T, Henderson K, Lightbourne M, Nelson B, Hodges JS. Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial. Diabetes Care. 2011 Oct;34(10):2174-9. doi: 10.2337/dc10-2399. Epub 2011 Aug 26.
- Nicolai SP, Kruidenier LM, Rouwet EV, Graffius K, Prins MH, Teijink JA. The walking impairment questionnaire: an effective tool to assess the effect of treatment in patients with intermittent claudication. J Vasc Surg. 2009 Jul;50(1):89-94. doi: 10.1016/j.jvs.2008.12.073.
- Sagar SP, Brown PM, Zelt DT, Pickett WL, Tranmer JE. Further clinical validation of the walking impairment questionnaire for classification of walking performance in patients with peripheral artery disease. Int J Vasc Med. 2012;2012:190641. doi: 10.1155/2012/190641. Epub 2012 Aug 2.
- Nead KT, Zhou M, Diaz Caceres R, Olin JW, Cooke JP, Leeper NJ. Walking impairment questionnaire improves mortality risk prediction models in a high-risk cohort independent of peripheral arterial disease status. Circ Cardiovasc Qual Outcomes. 2013 May 1;6(3):255-61. doi: 10.1161/CIRCOUTCOMES.111.000070. Epub 2013 Apr 30.
- McDermott MM, Greenland P, Guralnik JM, Liu K, Criqui MH, Pearce WH, Chan C, Schneider J, Sharma L, Taylor LM, Arseven A, Quann M, Celic L. Depressive symptoms and lower extremity functioning in men and women with peripheral arterial disease. J Gen Intern Med. 2003 Jun;18(6):461-7. doi: 10.1046/j.1525-1497.2003.20527.x.
- Arya S, Lee S, Zahner GJ, Cohen BE, Hiramoto J, Wolkowitz OM, Khakharia A, Binney ZO, Grenon SM. The association of comorbid depression with mortality and amputation in veterans with peripheral artery disease. J Vasc Surg. 2018 Aug;68(2):536-545.e2. doi: 10.1016/j.jvs.2017.10.092. Epub 2018 Mar 24.
- Ramirez JL, Grenon SM. Depression and peripheral artery disease: why we should care and what we can do. CVIR Endovasc. 2018;1(1):14. doi: 10.1186/s42155-018-0017-1. Epub 2018 Sep 18. No abstract available.
- Whipple MO, Schorr EN, Talley KMC, Lindquist R, Bronas UG, Treat-Jacobson D. A mixed methods study of perceived barriers to physical activity, geriatric syndromes, and physical activity levels among older adults with peripheral artery disease and diabetes. J Vasc Nurs. 2019 Jun;37(2):91-105. doi: 10.1016/j.jvn.2019.02.001. Epub 2019 Mar 11.
- Myers J, Kaykha A, George S, Abella J, Zaheer N, Lear S, Yamazaki T, Froelicher V. Fitness versus physical activity patterns in predicting mortality in men. Am J Med. 2004 Dec 15;117(12):912-8. doi: 10.1016/j.amjmed.2004.06.047.
- Myers J, Dupain M, Vu A, Jaffe A, Smith K, Fonda H, Dalman R. Agreement between activity-monitoring devices during home rehabilitation: a substudy of the AAA STOP trial. J Aging Phys Act. 2014 Jan;22(1):87-95. doi: 10.1123/japa.2012-0133. Epub 2013 Feb 14.
- Myers J, Chan K, Chen Y, Lit Y, Patti A, Massaband P, Kiratli BJ, Tamura M, Chertow GM, Rabkin R. Effect of a Home-Based Exercise Program on Indices of Physical Function and Quality of Life in Elderly Maintenance Hemodialysis Patients. Kidney Blood Press Res. 2021;46(2):196-206. doi: 10.1159/000514269. Epub 2021 Mar 26.
- ACSM Guidelines for Exercise Testing and Exercise Prescription, 9th edition. Baltimore: LW&W, 2021.
- Myers J. Principles of exercise prescription for patients with chronic heart failure. Heart Fail Rev. 2008 Feb;13(1):61-8. doi: 10.1007/s10741-007-9051-0.
- Borg GAV. Borg's Perceived Exertion and Pain Scales. Champaign, IL: Human Kinetics, 1998.
- Christopherson DJ, Phillips WT, Louie D. Effect of resistance training with Therabands on function ability and strength in cardiac rehabilitation participants. J Cardiopulm Rehabil. 1998;5:372-376.
- Ata R, Gandhi N, Rasmussen H, El-Gabalawy O, Gutierrez S, Ahmad A, Suresh S, Ravi R, Rothenberg K, Aalami O. Clinical validation of smartphone-based activity tracking in peripheral artery disease patients. NPJ Digit Med. 2018 Dec 11;1:66. doi: 10.1038/s41746-018-0073-x. eCollection 2018. Erratum In: NPJ Digit Med. 2020 Aug 7;3:105. doi: 10.1038/s41746-020-00316-0.
- Liang G, Huang X, Hirsch J, Mehmi S, Fonda H, Chan K, Huang NF, Aalami O, Froelicher VF, Lee DP, Myers J, Lee AS, Nguyen PK. Modest Gains After an 8-Week Exercise Program Correlate With Reductions in Non-traditional Markers of Cardiovascular Risk. Front Cardiovasc Med. 2021 Jun 17;8:669110. doi: 10.3389/fcvm.2021.669110. eCollection 2021.
- Arena R, Myers J, Williams MA, Gulati M, Kligfield P, Balady GJ, Collins E, Fletcher G; American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing. Assessment of functional capacity in clinical and research settings: a scientific statement from the American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology and the Council on Cardiovascular Nursing. Circulation. 2007 Jul 17;116(3):329-43. doi: 10.1161/CIRCULATIONAHA.106.184461. Epub 2007 Jun 18. No abstract available.
- Myers J, Buchanan N, Walsh D, Kraemer M, McAuley P, Hamilton-Wessler M, Froelicher VF. Comparison of the ramp versus standard exercise protocols. J Am Coll Cardiol. 1991 May;17(6):1334-42. doi: 10.1016/s0735-1097(10)80144-5.
- Froelicher V, Myers J. Exercise and the Heart. St Louis, WB Saunders, pp. 249-250, 2006.
- Shue P, Froelicher V. EXTRA: An expert system for exercise test reporting. J Non-Invas Test. 1998;II-4: 21-27.
- Gardner AW, Montgomery PS, Wang M. Minimal clinically important differences in treadmill, 6-minute walk, and patient-based outcomes following supervised and home-based exercise in peripheral artery disease. Vasc Med. 2018 Aug;23(4):349-357. doi: 10.1177/1358863X18762599. Epub 2018 Apr 19.
- McElrath M, Myers J, Chan K, Fonda H. Exercise adherence in the elderly: Experience with abdominal aortic aneurysm simple treatment and prevention. J Vasc Nurs. 2017 Mar;35(1):12-20. doi: 10.1016/j.jvn.2016.08.002.
- Hallgren KA, Witkiewitz K. Missing data in alcohol clinical trials: a comparison of methods. Alcohol Clin Exp Res. 2013 Dec;37(12):2152-60. doi: 10.1111/acer.12205. Epub 2013 Jul 24.
- Witkiewitz K, Falk DE, Kranzler HR, Litten RZ, Hallgren KA, O'Malley SS, Anton RF; Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. Methods to analyze treatment effects in the presence of missing data for a continuous heavy drinking outcome measure when participants drop out from treatment in alcohol clinical trials. Alcohol Clin Exp Res. 2014 Nov;38(11):2826-34. doi: 10.1111/acer.12543.
- Jackson D, White IR, Mason D, Sutton S. A general method for handling missing binary outcome data in randomized controlled trials. Addiction. 2014 Dec;109(12):1986-93. doi: 10.1111/add.12721.
- Myers J, Wagner D, Schertler T, Beer M, Luchinger R, Klein M, Rickli H, Muller P, Mayer K, Schwitter J, Dubach P. Effects of exercise training on left ventricular volumes and function in patients with nonischemic cardiomyopathy: application of magnetic resonance myocardial tagging. Am Heart J. 2002 Oct;144(4):719-25. doi: 10.1067/mhj.2002.124401.
- Dunlay SM, Witt BJ, Allison TG, Hayes SN, Weston SA, Koepsell E, Roger VL. Barriers to participation in cardiac rehabilitation. Am Heart J. 2009 Nov;158(5):852-9. doi: 10.1016/j.ahj.2009.08.010. Epub 2009 Sep 29.
- Sun V, Raz DJ, Kim JY, Melstrom L, Hite S, Varatkar G, Fong Y. Barriers and facilitators of adherence to a perioperative physical activity intervention for older adults with cancer and their family caregivers. J Geriatr Oncol. 2020 Mar;11(2):256-262. doi: 10.1016/j.jgo.2019.06.003. Epub 2019 Jun 14.
- Birtwistle SB, Jones I, Murphy R, Gee I, Watson PM. Family support for physical activity post-myocardial infarction: A qualitative study exploring the perceptions of cardiac rehabilitation practitioners. Nurs Health Sci. 2021 Mar;23(1):227-236. doi: 10.1111/nhs.12806. Epub 2021 Jan 26.
- Treat-Jacobson D, McDermott MM, Bronas UG, Campia U, Collins TC, Criqui MH, Gardner AW, Hiatt WR, Regensteiner JG, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Jan 22;139(4):e10-e33. doi: 10.1161/CIR.0000000000000623. No abstract available.
- American Association of Cardiovascular and Pulmonary Rehabilitation; American College of Cardiology Foundation; American Heart Association Task Force on Performance Measures (Writing Committee to Develop Clinical Performance Measures for Cardiac Rehabilitation); Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J. AACVPR/ACCF/AHA 2010 Update: Performance Measures on Cardiac Rehabilitation for Referral to Cardiac Rehabilitation/Secondary Prevention Services Endorsed by the American College of Chest Physicians, the American College of Sports Medicine, the American Physical Therapy Association, the Canadian Association of Cardiac Rehabilitation, the Clinical Exercise Physiology Association, the European Association for Cardiovascular Prevention and Rehabilitation, the Inter-American Heart Foundation, the National Association of Clinical Nurse Specialists, the Preventive Cardiovascular Nurses Association, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2010 Sep 28;56(14):1159-67. doi: 10.1016/j.jacc.2010.06.006. No abstract available.
- Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Vogt P, Ratti R, Muller P, Miettunen R, Buser P. Effect of exercise training on myocardial remodeling in patients with reduced left ventricular function after myocardial infarction: application of magnetic resonance imaging. Circulation. 1997 Apr 15;95(8):2060-7. doi: 10.1161/01.cir.95.8.2060.
- Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Muller P, Buser P, Stulz P, Vogt P, Ratti R. Effect of high intensity exercise training on central hemodynamic responses to exercise in men with reduced left ventricular function. J Am Coll Cardiol. 1997 Jun;29(7):1591-8. doi: 10.1016/s0735-1097(97)82540-5.
- Myers J, Fonda H, Vasanawala M, Chung K, Segall G, Chan K, Nguyen P. PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design. Contemp Clin Trials. 2019 Apr;79:37-43. doi: 10.1016/j.cct.2019.02.010. Epub 2019 Feb 20.
- Campbell EB, Delgadillo M, Lazzeroni LC, Louras PN, Myers J, Yesavage J, Fairchild JK. Cognitive Improvement Following Physical Exercise and Cognitive Training Intervention for Older Adults With MCI. J Gerontol A Biol Sci Med Sci. 2023 Mar 1;78(3):554-560. doi: 10.1093/gerona/glac189.
- Moore CS, Myers J, Yesavage JA, Fairchild JK. Ventilatory efficiency is associated with memory decay in older adults with amnestic mild cognitive impairment. Submitted, 2022
- Moore CS, Myers J, Yesavage JA, Fairchild JK. Assessment of physical activity in older adults with cognitive impairment. Submitted, 2022
- Fairchild JK, Myers J, Louras P, Jo B, McNerney MW, Salehi A, Hallmayer J, Yesavage J. A Combined physical and cognitive training program for veterans with mild cognitive impairment: A randomized clinical trial. Submitted, 2022.
Hjelpsomme linker
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- Bloom E. Prehabilitation evidence and insight review. Macmillan National Cancer Rehabilitation, 2018.
- Carrol AE, Frakt, A. It Saves Lives. It can save money. So why aren't we spending more on public health? NY Times 5/28/18
- Centers for Medicare & Medicaid Services. Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. mars 2024
Primær fullføring (Antatt)
31. januar 2027
Studiet fullført (Antatt)
25. juli 2027
Datoer for studieregistrering
Først innsendt
13. august 2024
Først innsendt som oppfylte QC-kriteriene
19. august 2024
Først lagt ut (Faktiske)
22. august 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. august 2024
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2024
Sist bekreftet
1. august 2024
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MYE0018APR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .