Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients

A prospective longitudinal and observational clinical study will be conducted with hospitalized heart failure patients.The main purpose is to know the level of physical activity of these patients after their discharge in relation to the orientation received during their hospitalization and identify the barriers perceived by these patients to participate in a cardiac rehabilitation program. The outcomes are available by telephone calls in 30 and 90 days after discharge.

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation; Physical Exercise; Heart Failure，Congestive

Detailed Description

Heart failure is a progression epidemic problem, parallel to population aging. The costs of this disease are estimates in 38 billion of dollars per year, many of those have a relationship to high number of hospitalizations and decompensated heart failure. Non-adherence to drug treatment and non-pharmacological measures as cardiac rehabilitation are the major causes of high number of mortality and hospitalizations by heart failure. Our objectives will be to identify in decompensated heart failure inpatients the level of physical activity that they done before hospitalization, the barriers for the non-use of cardiac rehabilitation and their disposition to changes of lifestyle. Correlation between level of physical activity and readmission in 30 and 90 days after hospital discharge will be done. To understand the profile of these patients and difficulties for to do physical exercise could help to make future actions with focus in to obtain high adherence to changes in lifestyle.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05652-000
    • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Protocol of heart failure patients will be maped since their hospitalizaztion, however, their approach to get in the study will be fulfilled when they had medical release in 72 hours.

Description

Inclusion criteria Patients in the heart failure protocol of the cardiology program with medical release in the next 72 hours

Exclusion criteria

• Inpatients for more than 30 days
• Younger than 18 years old
• Patients not recommended to do exercises (patients with osteoarticular alterations that doesn't allow the performance of physical exercise)
• Patients with cognitive impairment (Mini Mental <24), visual or psychiatric impairment which restrain the comprehension of the questionnaires

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Heart Failure Patients; Cardiac Rehabilitation in Advanced Heart Failure Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Know the physical activity level in heart failure patients before hospitalization	- To know the physical activity level in heart failure patients before the hospitalization using one questionnaire: the International Physical Activity Questionnaires (IPAQ).	Before hospitalization
Know cardiac rehabilitation barriers in heart failure patients	-To identify the cardiac rehabilitation barriers in heart failure patients using a likert scale CRBS (Cardiac Rehabilitation Barriers Scale) which assesses patients' perceptions regarding the personal (patient), professional (health professional) and institutional (system) barriers that affect participation and adherence to cardiac rehabilitation programs.	At screening
Know disposition for changes in life habits	- To identify the disposition for changes in life habits related to physical activity using the Disposition Scale described for Prochaska Jo and Diclemente with the results: pre contemplation, contemplation, preparation and action.	At screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Know the change from baseline physical activity level to 30 days after discharge	To know the physical activity level in heart failure patients 30 days after discharge using one questionnaire: the International Physical Activity Questionnaires (IPAQ).	30 days
Know the change from baseline physical activity level to 90 days after discharge	To know the physical activity level in heart failure patients 90 days after discharge using one questionnaire: the International Physical Activity Questionnaires (IPAQ).	90 days
Adhesion of orientation	Verify the adhesion of the orientation given in the hospitalization about medications and daily weight measure	90 days
New hospitalizations 30 and 90 days after discharge	Verify if there were new hospitalizations and its reasons in this period	30 and 90 days
Correlate new hospitalization with physical activity and orientations	Correlate the new hospitalization in 30 and 90 days after discharge with the participation in physical activity program and orientation given in the hospital (medications and daily weight measure) in the statistical analysis	90 days
Measure anxiety and depression	Measure anxiety and depression through HADS (Hospital Anxiety and Depression Scale) which shows if it is impossible, possible or probable.	At screening
Measure cognitive impairment	Measure if the patient presents cognitive impairment applying the MMSE (Mini-mental State Examination).	At screening
Correlate anxiety and depression with cognitive impairment	Correlate anxiety and depression with cognitive impairment in the statistical analysis	At screening

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Luciana Matos, Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
• Bocchi EA, Braga FG, Ferreira SM, Rohde LE, Oliveira WA, Almeida DR, Moreira Mda C, Bestetti RB, Bordignon S, Azevedo C, Tinoco EM, Rocha RM, Issa VS, Ferraz A, Cruz Fd, Guimaraes GV, Montera Vdos S, Albuquerque DC, Bacal F, Souza GE, Rossi Neto JM, Clausell NO, Martins SM, Siciliano A, Souza Neto JD, Moreira LF, Teixeira RA, Moura LZ, Beck-da-Silva L, Rassi S, Azeka E, Horowitz E, Ramires F, Simoes MV, Castro RB, Salemi VM, Villacorta Junior H, Vila JH, Simoes R, Albanesi F, Montera MW; Sociedasde Brasileira de Cardiologia. [III Brazilian Guidelines on Chronic Heart Failure]. Arq Bras Cardiol. 2009;93(1 Suppl 1):3-70. No abstract available. Portuguese.
• Hallal PC, Simoes E, Reichert FF, Azevedo MR, Ramos LR, Pratt M, Brownson RC. Validity and reliability of the telephone-administered international physical activity questionnaire in Brazil. J Phys Act Health. 2010 May;7(3):402-9. doi: 10.1123/jpah.7.3.402.
• Mendes M. Barriers to participation in cardiac rehabilitation programs. Rev Port Cardiol. 2011 May;30(5):509-14. No abstract available. English, Portuguese.
• Cabral-de-Oliveira AC, Ramos PS, Araujo CG. Distance from home to exercise site did not influence the adherence of 796 participants. Arq Bras Cardiol. 2012 Jun;98(6):553-8. doi: 10.1590/s0066-782x2012005000039. Epub 2012 Apr 19. English, Portuguese.
• Ghisi GL, Santos RZ, Schveitzer V, Barros AL, Recchia TL, Oh P, Benetti M, Grace SL. Development and validation of the Brazilian Portuguese version of the Cardiac Rehabilitation Barriers Scale. Arq Bras Cardiol. 2012 Apr;98(4):344-51. doi: 10.1590/s0066-782x2012005000025. Epub 2012 Mar 15. English, Portuguese.
• Mangini S, Pires PV, Braga FG, Bacal F. Decompensated heart failure. Einstein (Sao Paulo). 2013 Jul-Sep;11(3):383-91. doi: 10.1590/s1679-45082013000300022.
• Mair V, Breda AP, Nunes ME, Matos LD. Evaluating compliance to a cardiac rehabilitation program in a private general hospital. Einstein (Sao Paulo). 2013 Jul-Sep;11(3):278-84. doi: 10.1590/s1679-45082013000300004.
• Rabelo ER, Aliti GB, Goldraich L, Domingues FB, Clausell N, Rohde LE. Non-pharmacological management of patients hospitalized with heart failure at a teaching hospital. Arq Bras Cardiol. 2006 Sep;87(3):352-8. doi: 10.1590/s0066-782x2006001600019. English, Portuguese.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2249-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data acess requests will be reviewed by and internal or external Independent Review Panel. Requestors will be required to sign a Data Acess Agreement.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No