- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00255931
Impact of a Psychological Biofeedback-Relaxation Intervention on Clinical, Physical and Psychological Outcomes in Patients With Heart Failure
Biobehavioral Intervention in Heart Failure
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The long-term aim of this program of research is to improve physical and psychological health outcomes of adults with heart failure (HF). The specific aims of the randomized, controlled clinical trial are to test the effects of biofeedback-relaxation therapy in HF patients on rehospitalizations, cardiac mortality and quality of life, and on the secondary end-points of perceived control, anxiety, depression, skin temperature, plasma norepinephrine levels, and heart rate variability (HRV).
In the 1990s, HF emerged as a significant public health threat and reached epidemic proportions. Heart failure incidence and prevalence are expected to increase worldwide, and its impact to worsen dramatically. Individuals with HF suffer incapacitating physical symptoms, emotional distress, impaired quality of life, repeated rehospitalizations, and premature death. To combat the rising HF epidemic, it is crucial that researchers study new strategies to improve outcomes. Despite its potential as an effective partner to drug therapy, the role of nonpharmacologic intervention in HF management has received relatively little attention.
One may argue that drug therapy is effective enough that resources need not be expended on research of nonpharmacologic therapies. However, three points argue against this stance. First, despite substantial advances made in HF treatment with drug therapy, morbidity and mortality remain unacceptably high. As Kannel states, "innovations in treatment of...HF have thus far made a disappointingly small improvement in its…outlook". Second, although drug therapy frequently provides significant improvement in symptoms and functional ability, quality of life may not improve. This outcome is important for patients with HF because poorer quality of life independently predicts morbidity and mortality. Third, nonpharmacologic strategies can have effect sizes for important HF outcomes (e.g., rehospitalization rates/mortality and quality of life) that are similar to those seen with drug therapy. Recent studies demonstrated these therapies substantially improve outcomes beyond the level seen in the same patients with pharmacologic therapy.
Biofeedback-relaxation therapy is an innovative and promising nonpharmacologic strategy. An optimally effective treatment should have a beneficial effect on both pathophysiological and psychological manifestations of the target condition. This goal is especially important for a condition like HF, which has a profoundly negative impact on physical and psychological function. Hallmark pathophysiology in HF includes intense neurohumoral activation, initiated and sustained by the sympathetic nervous system (SNS), with marked vasoconstriction. Adverse psychological manifestations of chronic HF include feelings of loss of control, anxiety and depression. Both neurohumoral activation and the psychological consequences of HF contribute to poor quality of life, frequent HF hospitalizations, and increased mortality. As shown in the model in Figure 1, biofeedback-relaxation therapy takes three complementary, but separate pathways to improve outcomes. This biobehavioral therapy decreases SNS activation (as reflected by HRV and plasma norepinephrine), produces stress reduction (as reflected by changes in perceived control, anxiety and depression), and results in vasodilation (as reflected by skin temperature). Biofeedback-relaxation therapy can have a powerful influence because of these separate, yet complementary effects. For example, SNS activation is directly decreased by biofeedback-relaxation therapy, but also indirectly as a result of stress reduction with increased control, and decreased anxiety and depression. As a result of its physical and psychological effects, biofeedback-relaxation could have a clinically meaningful impact on rehospitalizations, survival and quality of life. For these reasons, biofeedback-relaxation may be an effective adjunct to pharmacologic therapy in the management of HF. Thus, the purpose of the proposed research is to examine the impact of biofeedback-relaxation training on HF patient outcomes.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40535
- University of Kentucky
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- confirmed diagnosis of chronic advanced HF. Other sample selection criteria include: 1) on stable doses of HF medication for at least one month; and 2) not referred for heart transplantation.
Exclusion Criteria:
- Patients will be excluded if they have: 1) valvular heart disease (as a primary cause of their HF; can have it if the primary cause is ischemic, hypertensive or idiopathic), peripartum heart failure, myocarditis; 2) history of cerebral vascular accident (CVA) within previous 3 months or major stroke sequelae; 3) history of major extremity vascular problems; 4) recent (within 3 months) myocardial infarction (MI); 5) coexisting terminal illness; 6) systolic blood pressure less than 80 mmHg; or 7) previous experience with biofeedback, relaxation .
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
|
Cognitive Behavioral Therapy and Relaxation/biofeedback
|
Comparateur placebo: 2
|
Untrained relaxation
|
Aucune intervention: 3
Usual Care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Examination of the impact of biofeedback-relaxation training on HF patient outcomes.
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Perceived Control
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Anxiety
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Depression
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Skin Temperature
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Heart Rate Variability
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Plasma Norepinephrine
Délai: Baseline, 3-, and 12-Months
|
Baseline, 3-, and 12-Months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Debra Moser, DNSc, RN, University of Kentucky
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 8567
- R01NR008567 (Subvention/contrat des NIH des États-Unis)
- R01NR008567-01A1 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Insuffisance cardiaque
-
Region SkaneInscription sur invitationInsuffisance cardiaque New York Heart Association (NYHA) Classe II | Insuffisance cardiaque Classe III de la New York Heart Association (NYHA)Suède
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... et autres collaborateursPas encore de recrutementInsuffisance cardiaque, systolique | Insuffisance cardiaque avec fraction d'éjection réduite | Insuffisance cardiaque New York Heart Association Classe IV | Insuffisance cardiaque Classe III de la New York Heart AssociationPologne
-
University of WashingtonAmerican Heart AssociationComplétéInsuffisance cardiaque, congestive | Altération mitochondriale | Insuffisance cardiaque New York Heart Association Classe IVÉtats-Unis
Essais cliniques sur Cognitive Behavioral Therapy
-
Norwegian Center for Violence and Traumatic Stress...King's College London; University of Oslo; Ministry of Health and Care Services...RecrutementSSPT | Qualité de vie | Troubles du sommeil | Symptômes dépressifsNorvège
-
VA Office of Research and DevelopmentComplétéTroubles de stress, post-traumatiqueÉtats-Unis
-
Weill Medical College of Cornell UniversityRecrutementDépression périnatale | Anxiété périnataleÉtats-Unis
-
University of WashingtonNational Institute on Drug Abuse (NIDA)ComplétéTroubles liés à l'utilisation de substances | Troubles de stress post-traumatique | Sexe à risqueÉtats-Unis
-
Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)Actif, ne recrute pasAccident vasculaire cérébral | Aphasie | Aphasie Non FluentÉtats-Unis
-
Columbia UniversityRésilié
-
NeuroTronik Inc.InconnueInsuffisance cardiaque | Insuffisance cardiaque aiguëParaguay
-
Microclinic InternationalRoyal Health Awareness Society (RHAS); Jordanian Ministry of Health (MoH)ComplétéHyperglycémie | Hypertension | Obésité | Diabète sucré, Type 2 | Diabète sucré | Diabète | Poids | Perte de poids | Pression artérielle | Gain de poids | Comportement social | Poids, Corps | Glycémie, hypertension | Mode de vie, Sain | Changement de poids, Corps | Comportement, Santé | Réduction des risques liés au mode... et d'autres conditionsJordan
-
NeuroTronik Inc.InconnueInsuffisance cardiaque aiguëPanama
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale...ComplétéEn bonne santéSuisse