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Completed

NCT Number: NCT03385837

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.

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Key information

Conditions

Heart Failure，Congestive Behavior Cardiac Rehabilitation Cardiovascular Diseases Heart Diseases Heart Failure Motor Activity Physical Exercise

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, 05652-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Know the physical activity level in heart failure patients before hospitalization

    Time frame: Before hospitalization

    • To know the physical activity level in heart failure patients before the hospitalization using one questionnaire: the International Physical Activity Questionnaires (IPAQ).

  2. Know cardiac rehabilitation barriers in heart failure patients

    Time frame: At screening

    -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.

  3. Know disposition for changes in life habits

    Time frame: At screening

    • 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.

Secondary outcomes

  1. Know the change from baseline physical activity level to 30 days after discharge

    Time frame: 30 days

    To know the physical activity level in heart failure patients 30 days after discharge using one questionnaire: the International Physical Activity Questionnaires (IPAQ).

  2. Know the change from baseline physical activity level to 90 days after discharge

    Time frame: 90 days

    To know the physical activity level in heart failure patients 90 days after discharge using one questionnaire: the International Physical Activity Questionnaires (IPAQ).

  3. Adhesion of orientation

    Time frame: 90 days

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

  4. New hospitalizations 30 and 90 days after discharge

    Time frame: 30 and 90 days

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

  5. Correlate new hospitalization with physical activity and orientations

    Time frame: 90 days

    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

  6. Measure anxiety and depression

    Time frame: At screening

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

  7. Measure cognitive impairment

    Time frame: At screening

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

  8. Correlate anxiety and depression with cognitive impairment

    Time frame: At screening

    Correlate anxiety and depression with cognitive impairment in the statistical analysis

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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