Training Intervention in Heart Failure and Frail Elderly Population

Summary

There is enough scientific evidence of the benefits detection of frailty in patients with heart failure, which is an important prognostic factor. The usefulness of screening frailty as flattering tool making diagnostic and therapeutic decisions in patients with heart failure and now emerges in various recent studies. However, it is not found in the literature any study on the potential effectiveness of a comprehensive intervention on the fragility that includes the physical section (endurance, strength, flexibility and balance), nutritional, hormonal (supplementation deficit D vitamin) and pharmacological (adjusted to clinical guidelines according to requirements) in patients with heart failure after hospitalization for cardiac decompensation, to improve survival and reduce cardiac decompensation and hospital admissions resulting in a better quality of life for these patients. Therefore, the investigators designed the following study.

Conditions

• Physical Activity

Interventions

OTHER

Multicomponent training intervention.

The intervention group will be included in a program specifically developed for this study based on the multidimensional continuous care of patients with heart failure and frailty diagnosis or prefrailty. A joint interdisciplinary nursing intervention including a physical part (endurance, strength, flexibility and balance).

OTHER

Nutrition intervention

Both groups will be included in a program of quarterly monitoring receiving nutritional support: nutritional advice plus enteral supplementation should specify.

OTHER

Cognitive intervention

Both groups will be included in a program of quarterly monitoring receiving cognitive support: detection and treatment of depression and delirium in medical consultation.

OTHER

D-vitamin intervention

Both groups will be included in a program of quarterly monitoring receiving hormonal support: supplementation of vitamin D if required with adjustment for guides.

OTHER

Occupational intervention

The intervention group will be included in a program specifically developed for this study based on the multidimensional continuous care of patients with heart failure and frailty diagnosis or prefrailty. A joint interdisciplinary nursing intervention including occupational support.

OTHER

Heart failure follow up.

Both groups will be included in a program specifically developed for this study based on the multidimensional continuous care of patients with heart failure and frailty diagnosis or prefrailty. A joint interdisciplinary medical intervention including and pharmacological treatment of heart failure and comorbidities adjusted according to recent clinical guidelines requirements.

Sponsors & Collaborators

• University of Valencia

  collaborator OTHER

• Hospital de la Ribera

  lead OTHER

Principal Investigators

• Francisco J Tarazona-Santabalbina, MD, PhD · Hospital Universitario de la Ribera

• Eduardo Rovira Daudi, MD, PhD · Hospital Universitario de la Ribera

• Carmen Gomez-Cabrera, MD, PhD · University of Valencia

• Jose Viña Ribes, MD, PhD · University of Valencia

• Maria Pilar Perez Ros, Nurse, PhD · Catholic University of Valencia

• Francisco Martínez Arnau, Physio, PhD · University of Valencia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-06-30

Completion

2016-10-31

Countries

• Spain

Study Locations