Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03385837
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Luciana Diniz Nagem Janot Matos, Hospital Israelita Albert Einstein

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.

Condition or disease
Heart Failure,Congestive Cardiac Rehabilitation Physical Exercise

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
Actual Study Start Date : March 1, 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385837


Contacts
Layout table for location contacts
Contact: Luciana Matos 00551121514100 luciana.matos@einstein.br

Locations
Layout table for location information
Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP) Recruiting
São Paulo, Brazil, 05652-000
Contact: Luciana Diniz Nagem Janot de Matos    00551121514100    luciana.matos@einstein.br   
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
Layout table for investigator information
Principal Investigator: Luciana Matos Hospital Israelita Albert Einstein

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Luciana Diniz Nagem Janot Matos, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03385837     History of Changes
Other Study ID Numbers: 2249-14
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available within 6 months of study completion.
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases