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Heart Failure，CongestiveNCT03385837

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

An observational study of Heart Failure，Congestive and Cardiac Rehabilitation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
70 participants
Where
1 siteBrazil
Study dates
1 Mar 2015to 30 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

    São Paulo, 05652-000

Other trials in Brazil

About this study

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.

Read the 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.

Medical subject headings
Heart Failure, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03385837
Study groupRoleWhat they receive
Heart Failure PatientsCardiac Rehabilitation in Advanced Heart Failure Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Before hospitalization

  2. 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.

    Measured: At screening

  3. 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.

    Measured: At screening

Secondary outcomes (8)

  1. 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).

    Measured: 30 days

  2. 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).

    Measured: 90 days

  3. Adhesion of orientation

    Verify the adhesion of the orientation given in the hospitalization about medications and daily weight measure

    Measured: 90 days

  4. New hospitalizations 30 and 90 days after discharge

    Verify if there were new hospitalizations and its reasons in this period

    Measured: 30 and 90 days

  5. 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

    Measured: 90 days

  6. Measure anxiety and depression

    Measure anxiety and depression through HADS (Hospital Anxiety and Depression Scale) which shows if it is impossible, possible or probable.

    Measured: At screening

  7. Measure cognitive impairment

    Measure if the patient presents cognitive impairment applying the MMSE (Mini-mental State Examination).

    Measured: At screening

  8. Correlate anxiety and depression with cognitive impairment

    Correlate anxiety and depression with cognitive impairment in the statistical analysis

    Measured: At screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2017
  2. Study start1 Mar 2015
  3. Primary completion30 Nov 2018
  4. Study completion30 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03385837
Sponsor's protocol ID
2249-14
Status last verified
Mar 2020
First submitted
30 Nov 2017
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • 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.

    PubMed 20551498

  • 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.

    PubMed 6880820

  • 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.

    PubMed 20963312

  • Mendes M. Barriers to participation in cardiac rehabilitation programs. Rev Port Cardiol. 2011 May;30(5):509-14. No abstract available. English, Portuguese.

    PubMed 21800479

  • 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.

    PubMed 22522721

  • 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.

    PubMed 22426990

  • 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.

    PubMed 24136770

  • 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.

    PubMed 24136752

  • 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.

    PubMed 17057937

  • Carvalho ACSM, Groehs RV, Pereira C, Soares VL, Mota TP, Grace SL, Matos LDNJ. Barriers to cardiac rehabilitation and their association with hospital readmission in patients with heart failure. Einstein (Sao Paulo). 2025 Mar 17;23:eAO0713. doi: 10.31744/einstein_journal/2025AO0713. eCollection 2025.

    PubMed 40105570

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure，Congestive and Cardiac Rehabilitation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Know the physical activity level in heart failure patients before hospitalization (time frame: Before hospitalization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03385837, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.

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