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Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)

23. november 2011 oppdatert av: Heather Arthur, McMaster University

The Effect of Hospital Versus Home-based Exercise on Psychosocial and Physical Outcomes in Patients With Chronic Stable Heart Failure

The objective of this study is to compare the effect of monitored, home-based exercise versus hospital-based exercise on the quality of life of patients with congestive heart failure. Secondary objectives are to assess the effect of the intervention on exercise capacity and caregiver burden.

The investigators hypothesize that the exercise training in the home-based environment will be superior to hospital based exercise training.

Studieoversikt

Detaljert beskrivelse

Congestive heart failure (CHF) is a chronic disease that is associated with enormous burden of illness. Patients with CHF have diminished health-related quality of life, and due to the high demand associated with their everyday activities and self-management, there is consequently a burden upon family caregivers. Though exercise is a component of clinical practice guidelines for the management of CHF, previous studies have not examined the interrelationships among changes in exercise capacity, health-related quality of life (HRQL) and important predictor variables such as self-efficacy, as a result of exercise training in CHF patients. Furthermore, research to date has failed to examine whether a hospital-based or a home-based approach to exercise is the best-suited strategy for long-term adoption and benefit from exercise training. Thus, the most important effective approach to, and environment for, exercise training to improve the health and self-management of CHF patients has not yet been determined. This study will address some important gaps in the existing literature related to the benefits of exercise in CHF, specifically how different exercise approaches and strategies contribute to an individual's HRQL and self-efficacy.

This is a prospective, randomized controlled trial using a two-group, repeated measures design. Male and female patients with New York Heart Association (NYHA) Functional Class I-III CHF will be eligible to participate. Participants will be randomized to receive either supervised, hospital-based exercise or monitored home-based exercise. The participants in the study will train for a period of six months and will be reassessed six months following completion of the intervention to assess sustainability of any observed changes.

Studietype

Intervensjonell

Registrering (Faktiske)

62

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • chronic stable heart failure
  • NYHA class I, II or III
  • willing and able to regularly attend a supervised exercise program
  • provision of written, informed consent

Exclusion Criteria:

  • unstable angina in the last month
  • recent acute MI (last 3 months) which precipitated heart failure
  • hospitalized for heart failure in past month
  • severe chronic pulmonary disease (FEV1 <40%)
  • uncontrolled hypertension (B/P >140/90)
  • orthopedic, neurological or psychiatric illness precluding participation in exercise
  • heart failure that is amenable to revascularization, which is planned in the near future
  • NYHA class IV

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: home based exercise training

Participants in the home-based group will be advised to exercise, a minimum of 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Prescriptions will include the same elements of those for the hospital group:

  • 5-10 min warm-up
  • 30 min aerobic interval training (walking or stationary bicycle)
  • 10 min cool-down

Home-based participants will be asked to record their exercise in an exercise log book and will receive bi-weekly telephone calls from exercise personnel to monitor progress, assess and document adherence, revise the exercise prescription if necessary and provide support and education. Patient safety will be monitored during each call and serious health concerns will be relayed, with the patient's permission, to their primary health provider. Patients in this group will be encouraged to call the exercise specialist or kinesiologist with concerns or questions throughout the study.

Aktiv komparator: supervised exercise training

Patients in the hospital-based group will participate in supervised, on-site, group exercise sessions 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Trained exercise personnel (kinesiologists and exercise specialists) will supervise these sessions. Exercise sessions will include:

  • 5-10 min of warm-up
  • 30 min of aerobic interval training using stationary cycles, treadmills and arm ergometers
  • 10 min of cool down

Exercise will be tracked by the participant in exercise log books.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in health-related quality of life (HRQL): Generic and disease specific
Tidsramme: baseline, 3 months, 6 months, one year

The Medical Outcomes Short Form-36 will be used to measure generic HRQL.

The Minnesota Living with Heart Failure (MLQHF) Questionnaire will be used to measure disease specific HRQL.

baseline, 3 months, 6 months, one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in exercise capacity (peak exercise oxygen uptake - VO2)
Tidsramme: baseline, 3 months, 6 months, one year
PEAK VO2 will be measured while performing a symptom-limited cycle erometry exercise test.
baseline, 3 months, 6 months, one year
Change in self-efficacy for exercise
Tidsramme: baseline, 3 months, 6 months, one year
Self-efficacy for exercise will be measured using a self-efficacy for exercise scale developed for clinicial use among cardiac patients (Ewart & Taylor, 1985)
baseline, 3 months, 6 months, one year
Change in caregiver burden
Tidsramme: baseline, 3 months, 6 months, one year
The Caregiver Burden Scale (CBS) will be used to measure caregiver burden.
baseline, 3 months, 6 months, one year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Heather M Arthur, PhD, Hamilton Health Sciences Corporation
  • Studiestol: Robert S McKelvie, MD, PhD, Hamilton Health Sciences Corporation
  • Studiestol: Jennifer Kodis, MA, Hamilton Health Scienes
  • Studiestol: Kevin Thorpe, MSc, University of Toronto
  • Studiestol: Catherine Demers, MD, MSc, Hamilton Health Sciences Corporation

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

1. juli 2003

Primær fullføring (Faktiske)

1. juni 2006

Studiet fullført (Faktiske)

1. november 2007

Datoer for studieregistrering

Først innsendt

22. november 2011

Først innsendt som oppfylte QC-kriteriene

23. november 2011

Først lagt ut (Anslag)

29. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. november 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. november 2011

Sist bekreftet

1. november 2011

Mer informasjon

Begreper knyttet til denne studien

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. .

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