NCT02365155

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

February 4, 2015

Last Update Submit

March 7, 2016

Conditions

Physical Activity

Keywords

FrailtyHeart failurePhysical activityCognitive state

Outcome Measures

Primary Outcomes (1)

  • Mortality

    The primary study endpoint is the mortality reduction.

    365 days (plus or minus 3 days)

Secondary Outcomes (5)

  • Mini-Mental State Examination (MMSE)

    365 days(plus or minus 3 days)

  • Short Physical Performance Battery and Physical Performance Test

    365 days(plus or minus 3 days)

  • Composite effect of a multicomponent training intervention on systemic biomarkers of frailty

    365 days(plus or minus 3 days)

  • Geriatric Depression Scale

    365 days(plus or minus 3 days)

  • Quality of life: EuroQol-5D

    365 days(plus or minus 3 days)

Study Arms (2)

Intervention group.

EXPERIMENTAL

Multicomponent training intervention; Nutrition intervention; Cognitive intervention; D-vitamin intervention; Occupational intervention; Heart failure follow up.

Other: Multicomponent training intervention.Other: Nutrition interventionOther: Cognitive interventionOther: D-vitamin interventionOther: Occupational interventionOther: Heart failure follow up.

Control group.

ACTIVE COMPARATOR

Nutrition intervention; Cognitive intervention; D-vitamin intervention; Occupational intervention; Heart failure follow up.

Other: Nutrition interventionOther: Cognitive interventionOther: D-vitamin interventionOther: Occupational interventionOther: Heart failure follow up.

Interventions

Multicomponent training intervention.OTHER

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).

Intervention group.
Nutrition interventionOTHER

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

Control group.Intervention group.
Cognitive interventionOTHER

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

Control group.Intervention group.
D-vitamin interventionOTHER

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

Control group.Intervention group.
Occupational interventionOTHER

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.

Control group.Intervention group.
Heart failure follow up.OTHER

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.

Control group.Intervention group.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 70 years.
  • Individuals hospitalized in internal medicine at the Hospital de la Ribera with primary or secondary diagnosis of heart failure as before:
  • I. Clinical heart failure criteria. (Clinical Practice Guidelines 2012 HF) (Annex 1).
  • II. Evidence of ventricular systolic or diastolic dysfunction on echocardiographic (TTE).
  • Pre-frailty or frailty according to the Fried frailty scale, fulfilling at least 1 criterion.

You may not qualify if:

  • Expectation of life less than one year.
  • Cancer Patient in active treatment with chemotherapy / biotherapy or radiotherapy.
  • Major surgery within 6 months prior to baseline.
  • Barthel score ≤ 50 points.
  • Moderate to severe cognitive impairment measured by GDS ≥ 5
  • Severe valvular measured by echocardiogram in the last 6 months.
  • Percutaneous or surgical coronary revascularization in the last 3 months.
  • Acute coronary event in the last month.
  • Dyspnoea baseline NYHA IV / IV.
  • COPD / Asthma severe degree or other pathology that conditions severe impairment of lung function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de la Ribera

Alzira, Valencia, 46600, Spain

Location

MeSH Terms

Conditions

Motor ActivityFrailtyHeart Failure

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Francisco J Tarazona-Santabalbina, MD, PhD

    Hospital Universitario de la Ribera

    STUDY DIRECTOR

  • Eduardo Rovira Daudi, MD, PhD

    Hospital Universitario de la Ribera

    STUDY DIRECTOR

  • Carmen Gomez-Cabrera, MD, PhD

    University of Valencia

    STUDY DIRECTOR

  • Jose Viña Ribes, MD, PhD

    University of Valencia

    STUDY DIRECTOR

  • Maria Pilar Perez Ros, Nurse, PhD

    Catholic University of Valencia

    STUDY DIRECTOR

  • Francisco Martínez Arnau, Physio, PhD

    University of Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medicine doctor.

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 18, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

ES(1)