Clinical trial NCT03385837: Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
Official title: Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure，Congestive
Cardiac Rehabilitation
Physical Exercise
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Know the physical activity level in heart failure patients before hospitalization
timeFrame: Before hospitalization
measure: Know cardiac rehabilitation barriers in heart failure patients
timeFrame: At screening
measure: Know disposition for changes in life habits
timeFrame: At screening
Secondary outcomes:
measure: Know the change from baseline physical activity level to 30 days after discharge
timeFrame: 30 days
measure: Know the change from baseline physical activity level to 90 days after discharge
timeFrame: 90 days
measure: Adhesion of orientation
timeFrame: 90 days
measure: New hospitalizations 30 and 90 days after discharge
timeFrame: 30 and 90 days
measure: Correlate new hospitalization with physical activity and orientations
timeFrame: 90 days
measure: Measure anxiety and depression
timeFrame: At screening
measure: Measure cognitive impairment
timeFrame: At screening
measure: Correlate anxiety and depression with cognitive impairment
timeFrame: At screening
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Luciana Matos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Mendes M. Barriers to participation in cardiac rehabilitation programs. Rev Port Cardiol. 2011 May;30(5):509-14. No abstract available. English, Portuguese.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.