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Cardiac Rehabilitation Program in Peripheral Arterial Disease

5. september 2019 opdateret af: University of Kansas Medical Center

To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.

The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

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
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Medical Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with PAD post-revascularization (stent, angioplasty, or bypass).
  • Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.

Exclusion Criteria:

  • Below or above the knee amputation.
  • Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
  • Unfavorable short term prognosis and limited life expectancy (<2 years)
  • Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
  • Prior history of having dropped out of CR without completing.
  • Unwilling to consent for all aspects of CR or study participation.
  • Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
  • Pregnancy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cardiac Rehabilitation Group
Participants randomized to this group will undergo cardiac rehabilitation program.
Andet: Cardiac Rehabilitation Program

Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.

Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.
Aktiv komparator: Control Group
Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
Andet: Conventional Therapy
Participants will be asked to complete tests and questionnaires that would normally be done for their condition.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 6 minute walk test
Tidsramme: Change from Baseline to Up to 6 Months
Results will be measured in meters.
Change from Baseline to Up to 6 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short Form Health Survey 36 (SF-36)
Tidsramme: Change from Baseline to Up to 6 Months
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Change from Baseline to Up to 6 Months
Short Form Health Survey 36 (SF-36)
Tidsramme: Change from Baseline to Week 18
Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.
Change from Baseline to Week 18
Vascular Quality of Life Questionnaire-6 (VascuQol6)
Tidsramme: Change from Baseline to Up to 6 Months

The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.

Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Change from Baseline to Up to 6 Months
Vascular Quality of Life Questionnaire-6 (VascuQol6)
Tidsramme: Change from Baseline to Week 18

The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings.

Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Change from Baseline to Week 18
Absolute Claudication Distance (ACD)
Tidsramme: Change from Baseline to Up to 6 Months
ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters
Change from Baseline to Up to 6 Months
Functional Claudication Distance (FCD)
Tidsramme: Change from Baseline to Up to 6 Months
FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.
Change from Baseline to Up to 6 Months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Kansas Medical Center

Efterforskere

  • Ledende efterforsker: Kamal Gupta, MD, University of Kansas Medical Center

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)

13. april 2017

Primær færdiggørelse (Faktiske)

11. maj 2019

Studieafslutning (Faktiske)

11. maj 2019

Datoer for studieregistrering

Først indsendt

11. august 2017

Først indsendt, der opfyldte QC-kriterier

11. august 2017

Først opslået (Faktiske)

16. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00140692

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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