Hospital Versus Home Based Exercise in Patients With Chronic Stable Heart Failure (PEAK-HF)
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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:
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. |
|
Comparatore attivo: 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:
Exercise will be tracked by the participant in exercise log books. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in health-related quality of life (HRQL): Generic and disease specific
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in exercise capacity (peak exercise oxygen uptake - VO2)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Heather M Arthur, PhD, Hamilton Health Sciences Corporation
- Cattedra di studio: Robert S McKelvie, MD, PhD, Hamilton Health Sciences Corporation
- Cattedra di studio: Jennifer Kodis, MA, Hamilton Health Scienes
- Cattedra di studio: Kevin Thorpe, MSc, University of Toronto
- Cattedra di studio: Catherine Demers, MD, MSc, Hamilton Health Sciences Corporation
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NA 5147
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .