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Prospective Aerobic Reconditioning Intervention Study (PARIS)

12. februar 2019 opdateret af: Wake Forest University

Exercise Conditioning in Elderly Patients With Heart Failure

The purpose of this study is :

  • To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.
  • To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.
  • To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In patients over age 65, cardiovascular disease accounts for the largest percentage of deaths, hospital days, doctor visits, and overall health care expenditures. In addition, heart failure is the most common discharge diagnosis in the elderly. Heart failure can be defined as a state in which cardiac output is insufficient to meet metabolic demands. This is most frequently manifested by symptoms of fatigue and dyspnea. Inherent in this definition is that symptoms may be increased or only occur during times when metabolic demand is increased, such as during exercise. As such, exercise intolerance is a hallmark of the heart failure syndrome. Exercise intolerance correlates not only with disease severity and also with subsequent mortality. Exercise tolerance can be objectively quantified during maximal symptom limited standardized exercise protocols by analysis of exercise time, workload, METS (metabolic equivalents), and oxygen consumption (V02)' These measures have appropriately become accepted as standards for functional assessment in this disorder as well as outcome measures following therapeutic interventions in HF. P.A.R.I.S. is a randomized, attention-controlled, single-blind trial of supervised aerobic exercise training in older patients with heart failure. The primary outcome is exercise capacity and the main secondary outcome is quality of life. Mechanistic outcomes were also examined. In PARIS, which focused on cardiac mechanisms, there were HFPEF and HFREF patients studied in parallel. In PARIS-II, there were only HFPEF patients which focused on vascular mechanisms.

Main outcomes have been reported (see citations below).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

201

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
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Baptist Health

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

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age greater than or equal to 60 years of age
  • Symptoms of congestive heart failure
  • Able to understand and give informed consent

Exclusion Criteria:

  • Age <60 years
  • Does not have CHF
  • Significant change in cardiac medication <3 weeks
  • Myocardial infarction <3 weeks
  • CABG surgery <3 months
  • Angina pectoris not controlled during daily activity by pharmacological therapy or at <4 METS activity
  • Sustained hypertension with systolic> 190 and diastolic> 110 on medications
  • Valvular heart disease as the primary etiology of CHF
  • Significant aortic stenosis
  • Stroke of <3 months or with any physical restriction impairment that would prevent participation in exercise programs
  • Chronic obstructive pulmonary disease on therapy that limits exercise duration
  • Uncontrolled diabetes mellitus
  • Active treatment for cancer or other noncardiovascular conditions with life expectancy less than three years
  • Anemia "10 gms Hb)
  • Renal insufficiency (cr >2.5 mg/dl)
  • Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder
  • Dementia - MMSE ~24 "22 for ~8th grade education)
  • Lack of an acoustic window sufficient to allow definition of endocardial borders on the screening echocardiogram.
  • Plans to leave area or be admitted to a nursing home within 2 years.
  • Inability to walk at least 420 feet in 6 minutes without a cane or other assistive device.
  • Inability to exercise at or near home.
  • At the discretion of the clinical staff, it is believed that the participant cannot or will not complete the protocol because of frailty, illness, or other reason.
  • Participation in a regular exercise regimen more than one time per week for at least twenty minutes per session; including but not limited to walking, swimming, weight lifting, golfing, or taking an exercise class.
  • Inability to ambulate without cane or other assistive device during biomechanics testing or treadmill.
  • Inability to attend at least fourteen weeks of the facility-based intervention

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Control
Control group continues with their daily activity as they were prior to randomization. Receive bi-weekly follow-up phone calls to assess health status and encourage adherence with protocol.
Adfærdsmæssigt: Control
Control group continues daily life as prior to randomization.
Aktiv komparator: Exercise
Exercise classes three times per week in a controlled, supervised environment.
Adfærdsmæssigt: Exercise
Exercise classes three times per week in a controlled, supervised environment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Peak exercise capacity
Tidsramme: 16 weeks
16 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Livskvalitet
Tidsramme: 16 uger
16 uger

Samarbejdspartnere og efterforskere

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

Sponsor

Wake Forest University

Samarbejdspartnere

National Institutes of Health (NIH)
National Institute on Aging (NIA)

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

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. juli 1993

Primær færdiggørelse (Faktiske)

1. december 2004

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

29. april 2010

Først indsendt, der opfyldte QC-kriterier

29. april 2010

Først opslået (Skøn)

30. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.A.R.I.S. I and II
  • R01AG018915 (U.S. NIH-bevilling/kontrakt)
  • R01AG012257 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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