Præhabilitering og genoptræning i PAD (PREPARE-IT)
19. august 2024 opdateret af: Jonathan Myers, Palo Alto Veterans Institute for Research
Præhabilitering og rehabilitering i PAD: Et randomiseret træningsinterventionsforsøg (PREPARE-IT)
At bestemme effektiviteten af præ- og postoperativ træningsterapi hos patienter, der gennemgår perifer arteriestenting for perifer arteriel sygdom.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Perifer arteriesygdom (PAD) er en form for hjerte-kar-sygdom, der påvirker arterierne, der leverer blodgennemstrømningen til benene. Forekomsten af PAD stiger hurtigt i USA. Når PAD er alvorlig, kan det forårsage smerte ved bevægelse og begrænse en persons evne til at gå eller udføre deres normale daglige aktiviteter. Ved svær PAD udføres ofte en procedure, hvor en arterie holdes åben med et lille rør kaldet en stent.
Programmer for træningsbaseret genoptræning har vist sig i høj grad at hjælpe disse patienter med hensyn til de smerter, de oplever ved at gå, deres evne til at udføre daglige aktiviteter eller dem, der kræves af arbejdet, og forbedret livskvalitet. Der er også en nyere form for terapi, kaldet præhabilitering, som har vist sig at have vigtige fordele for patienter med PAD. Præhabilitering involverer fire til seks ugers træningsterapi og livsstilsanbefalinger, før man gennemgår en stentprocedure. Præhabilitering hjælper patienter med at forbedre træningstolerance og foretage livsstilsændringer, der forbedrer risikofaktorer før proceduren. De, der deltager i præhabiliteringsprogrammer, har færre komplikationer med stentproceduren, tilbringer færre dage på hospitalet og har en bedre evne til at træne og hurtigere vende tilbage til arbejdet.
Selvom fordelene ved præhabilitering og rehabilitering er veletablerede, undlader de fleste læger at anbefale disse behandlinger til deres patienter, der gennemgår en stentprocedure for PAD. Forskerholdet vil undersøge virkningen af præhabilitering, rehabilitering eller begge terapiformer. Resultaterne vil sandsynligvis tilskynde flere læger til at anbefale den bedste løsning til deres patienter og muligvis til at anbefale både præhabilitering og rehabilitering blandt patienter, der skal have en stentprocedure.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jonathan N Myers, PhD
- Telefonnummer: 64661 650-493-5000
- E-mail: drj993@aol.com
Undersøgelse Kontakt Backup
- Navn: Charles G Gronau, DCEP
- Telefonnummer: 618-746-69565
- E-mail: gronauc92@gmail.com
Studiesteder
-
-
California
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Palo Alto, California, Forenede Stater, 94304
- Rekruttering
- VA Palo Alto Health Care System
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Kontakt:
- Jonathan N Myers, PhD
- Telefonnummer: 64661 650-493-5000
- E-mail: drj993@aol.com
-
Kontakt:
- Charles G Gronau, DCEP
- Telefonnummer: 618-746-6956
- E-mail: gronauc92@gmail.com
-
Ledende efterforsker:
- Jonathan N Myers, PhD
-
Underforsker:
- Charles G Gronau, DCEP
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Underforsker:
- Khin N Chan, MD
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Underforsker:
- Pallavi Gautam, MPT
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-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Mand eller kvinde voksen diagnosticeret med perifer arteriesygdom (PAD)
- Oplever bensmerter under gang
- Planlagt at have en stent til PAD
- Kan udføre træning sikkert
- Postmenopausal og ikke af den fødedygtige evne
Ekskluderingskriterier:
- Medicinsk ustabile patienter
- Seneste MI inden for 3 måneder
- Malignitet
- Ukontrolleret diabetes mellitus (HBA1C ≥8 mmol/l)
- Alkoholisme eller andet rekreativt stofbrug
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Præhabilitering
Forsøgspersoner, der er randomiseret til præhabiliteringsgruppen, vil gennemgå 6 ugers individualiseret træningsterapi, inklusive en 1-uges ramp-up periode (3 sessioner) udført på VAPAHCS rehabiliteringsfaciliteten.
Forsøgspersonerne vil derefter primært motionere hjemme, med en klinikøvelse, der gentages ugentligt i hele deres deltagelse.
Disse sessioner vil være individualiserede baseret på tolerance og i overensstemmelse med standardiserede retningslinjer, men vil generelt bestå af 45-60 minutters superviseret træning, der kombinerer aerobic og modstandstræning, inklusive opvarmning og nedkøling.
Under hele undersøgelsen vil forsøgspersonerne blive bedt om at udføre 30 minutters daglig uovervåget aerob træning efter eget valg, med vægt på at forbedre gangpræstationerne derhjemme.
Retningslinjer for patientovervågning, sikkerhed og ordination skitseret af American Heart Association, American College Sports Medicine og American Association of Cardiovascular and Pulmonary Rehabilitation vil blive fulgt.
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Aerob træning og modstandsøvelser vil være en del af præhabiliterings- og genoptræningsprogrammerne.
I betragtning af tilstedeværelsen af PAD vil der blive lagt særlig vægt på volumen af gang og forbedring af gangpræstation.
Andre navne:
Præhabiliterings- og rehabiliteringsprogrammerne omfatter alle kernekomponenter af rehabilitering som beskrevet i retningslinjer.
Det nuværende kliniske VAPAHCS-program omfatter rygestop, ernæring, risikofaktorstyring og henvisninger til psykosocial rådgivning efter behov, og disse tjenester vil være tilgængelige for det aktuelle forslag.
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Aktiv komparator: Rehabilitering
Forsøgspersoner, der er randomiseret til rehabiliteringsgruppen, vil påbegynde træningssessioner cirka 2 uger efter endovaskulær intervention som beskrevet i retningslinjer for PAD.
Patientstabilitet og såråbenhed vil være altafgørende overvejelser, før en patient påbegynder rehabiliteringsprogrammet.
I lighed med præhabilitering vil forsøgspersonerne gennemgå en 1-uges, 3 sessions-familiariseringsperiode udført på VAPAHCS-rehabiliteringsfaciliteten, og derefter vende tilbage en gang om ugen til klinikovervågede sessioner.
De ugentlige personlige besøg vil blive gennemført på rehabiliteringscentret for at overvåge og tilskynde til overholdelse, gennemgå aktivitetsspørgeskemaer, downloade accelerometridata og adressere eventuelle kliniske problemer.
I lighed med deltagere i præhabiliteringsgruppen vil den 6-ugers genoptræningsperiode være individualiseret og følge standardiserede retningslinjer designet til genoptræning hos patienter med PAD.
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Aerob træning og modstandsøvelser vil være en del af præhabiliterings- og genoptræningsprogrammerne.
I betragtning af tilstedeværelsen af PAD vil der blive lagt særlig vægt på volumen af gang og forbedring af gangpræstation.
Andre navne:
Præhabiliterings- og rehabiliteringsprogrammerne omfatter alle kernekomponenter af rehabilitering som beskrevet i retningslinjer.
Det nuværende kliniske VAPAHCS-program omfatter rygestop, ernæring, risikofaktorstyring og henvisninger til psykosocial rådgivning efter behov, og disse tjenester vil være tilgængelige for det aktuelle forslag.
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Eksperimentel: Præhabilitering og genoptræning
Forsøgspersoner, der er randomiseret til præhabiliterings- og rehabiliteringsgruppen, vil gennemgå både de 6 ugers præhabilitering præoperativt og 6 ugers rehabilitering postoperativt som beskrevet i deres respektive armbeskrivelser.
|
Aerob træning og modstandsøvelser vil være en del af præhabiliterings- og genoptræningsprogrammerne.
I betragtning af tilstedeværelsen af PAD vil der blive lagt særlig vægt på volumen af gang og forbedring af gangpræstation.
Andre navne:
Præhabiliterings- og rehabiliteringsprogrammerne omfatter alle kernekomponenter af rehabilitering som beskrevet i retningslinjer.
Det nuværende kliniske VAPAHCS-program omfatter rygestop, ernæring, risikofaktorstyring og henvisninger til psykosocial rådgivning efter behov, og disse tjenester vil være tilgængelige for det aktuelle forslag.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tid til claudicatio smerter
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Tid til den første indtræden af claudicatio-smerter med træningsløbebåndstest.
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Baseline, 6 uger, 14 uger, 22 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Højeste VO2
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Peak V02 vil blive bestemt på et løbebånd ved hjælp af en individualiseret rampeprotokol med indsamling af kontinuerlige respiratoriske gasudvekslingsresponser.
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Baseline, 6 uger, 14 uger, 22 uger
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6-minutters gangtest (6MWT)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Samlet gåafstand (meter) på 6 minutter.
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Baseline, 6 uger, 14 uger, 22 uger
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Walking Impairment Questionnaire (WIQ)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Udviklet til at evaluere gangbegrænsninger hos patienter med PAD.
Vurderer individers evne til at gå definerede afstande og hastigheder og gå op ad trapper.
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Baseline, 6 uger, 14 uger, 22 uger
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Peripheral Artery Questionnaire (PAQ)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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20-element spørgeskema udviklet og valideret specifikt til PAD og er designet til at kvantificere patienters fysiske begrænsninger, symptomer, sociale funktion, behandlingstilfredshed og livskvalitet.
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Baseline, 6 uger, 14 uger, 22 uger
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Gåture
Tidsramme: Op til 22 uger
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Fysiske aktivitetsmønstre, udtrykt som skridt/dag, vil blive kvantificeret ved hjælp af fitness/sundhedssporingsenhed.
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Op til 22 uger
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Energiforbrug
Tidsramme: Op til 22 uger
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Energiforbruget vil blive kvantificeret ved hjælp af fitness-/sundhedssporingsenhed.
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Op til 22 uger
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Stolen hæver
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Antal gentagelser gennemført inden for 60 sekunder (46 cm højt sæde).
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Baseline, 6 uger, 14 uger, 22 uger
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Overkroppens styrke
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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1 gentagelse maks. for brystpres.
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Baseline, 6 uger, 14 uger, 22 uger
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Styrke i underkroppen
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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1 gentagelse max for Leg Extension.
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Baseline, 6 uger, 14 uger, 22 uger
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Håndgrebsstyrke
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Maksimal isometrisk styrke vil blive målt ved hjælp af et håndgrebsdynamometer.
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Baseline, 6 uger, 14 uger, 22 uger
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Insulinfølsomhed
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Fastende glukose- og insulinprøver vil blive udtaget fra blodprøver for at generere homeostasemodelvurdering af insulinresistens (HOMA-IR) score.
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Baseline, 6 uger, 14 uger, 22 uger
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Lipidpanel
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Fastende totalkolesterol, LDL, HDL og triglycerider vil blive vurderet fra blodprøvetagning.
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Baseline, 6 uger, 14 uger, 22 uger
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Natrium
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Standard Chem 20 blodprøver vil blive brugt til at opnå natrium i blodværdi.
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Baseline, 6 uger, 14 uger, 22 uger
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Homocystein
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Homocystein vil blive vurderet fra blodprøvetagning.
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Baseline, 6 uger, 14 uger, 22 uger
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Højfølsomt C-reaktivt protein (hs-CRP)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Højfølsomt C-reaktivt protein (hs-CRP) vil blive vurderet fra blodprøvetagning.
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Baseline, 6 uger, 14 uger, 22 uger
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Interleukin-6 (IL-6)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Interleukin-6 (IL-6) vil blive vurderet fra blodprøvetagning.
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Baseline, 6 uger, 14 uger, 22 uger
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D-dimer
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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D-dimer vil blive vurderet fra blodprøvetagning.
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Baseline, 6 uger, 14 uger, 22 uger
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Blodprotein
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå blodproteinværdi.
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Baseline, 6 uger, 14 uger, 22 uger
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Albumin
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå albumin i blodværdi.
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Baseline, 6 uger, 14 uger, 22 uger
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Kalcium
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå calcium i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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Kalium
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå kalium i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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Chlorid
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå klorid i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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Kuldioxid
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodudtagning vil blive brugt til at opnå kuldioxid i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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AST/GOTU/l
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå AST/GOTU/l i blodværdi.
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Baseline, 6 uger, 14 uger, 22 uger
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ALT/GPT
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå ALT/GPT i blodværdi.
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Baseline, 6 uger, 14 uger, 22 uger
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ALK Phosphatase
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå ALT/GPT i blodværdi.
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Baseline, 6 uger, 14 uger, 22 uger
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Bilirubin
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå total bilirubin i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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Urea nitrogen
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå urinstofnitrogen i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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Kreatinin
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå kreatinin i blodværdien.
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Baseline, 6 uger, 14 uger, 22 uger
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eGFR
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Blodtagning vil blive brugt til at opnå eGFR-værdi.
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Baseline, 6 uger, 14 uger, 22 uger
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Endotelfunktion
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Endo Pat 2000-systemet vil blive brugt til at udføre denne procedure.
Begge underarme vil være okkluderet med en standard blodtryksmanchet i 5 minutter.
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Baseline, 6 uger, 14 uger, 22 uger
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Ankel-brachial indeks (ABI)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Brug af en standard brachial arterie cuff-metode med en Doppler-ultralydssonde ved den bageste tibiale arterie til at bestemme ABI.
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Baseline, 6 uger, 14 uger, 22 uger
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Træningsfordele og barriereskala (EBBS)
Tidsramme: Baseline, 6 uger, 14 uger, 22 uger
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Opfattede barrierer og fordele ved fysisk aktivitet vil blive vurderet ved hjælp af to metoder: et semistruktureret interview og administration af Exercise Benefits and Barriers Scale (EBBS), for at opnå både åbne kvalitative og kvantitative data om disse konstruktioner.
EBBS'en kan bruges i sin helhed eller som to separate skalaer.
Som helhed varierer scoren for EBBS fra 43 til 172, hvor en højere score er, at den enkelte opfatter træning mere positivt.
Når fordelsskalaen bruges alene, er scoreintervallet mellem 29 og 116, og jo højere score er, at den enkelte opfatter træning mere positivt.
Når barriereskalaen bruges alene, er scoreintervallet mellem 14 og 56.
Jo højere score på barriereskalaen, jo større er opfattelsen af barrierer for træning.
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Baseline, 6 uger, 14 uger, 22 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
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
- 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.
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- Thurston B, Dawson J. Ankle Brachial Pressure Index: An update for the vascular specialist and general practitioner. Vascular. 2019 Oct;27(5):560-570. doi: 10.1177/1708538119842395. Epub 2019 Apr 5. No abstract available.
- 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.
- Hirsch AT, Gotto AM Jr. Undertreatment of dyslipidemia in peripheral arterial disease and other high-risk populations: an opportunity for cardiovascular disease reduction. Vasc Med. 2002;7(4):323-31. doi: 10.1191/1358863x02vm453ra.
- 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.
Hjælpsomme links
- U.S. Markets for Peripheral Vascular Stents
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- Wilson C, Colombo R. Association of Community Cancer Centers. Making the business case for implementing prehabilitation services
- 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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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 (Faktiske)
7. marts 2024
Primær færdiggørelse (Anslået)
31. januar 2027
Studieafslutning (Anslået)
25. juli 2027
Datoer for studieregistrering
Først indsendt
13. august 2024
Først indsendt, der opfyldte QC-kriterier
19. august 2024
Først opslået (Faktiske)
22. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. august 2024
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2024
Sidst verificeret
1. august 2024
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MYE0018APR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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