Evaluation of the Six Minute Walk Test and Other Instruments in Heart Failure

August 5, 2014 updated by: Débora Lara Zuza Scheucher, Federal University of Uberlandia

Evaluation of the Six Minute Walk Test, Heart Rate Variability and Quality of Life in Heart Failure Patients on Beta-blocker Treatment

The purpose of this study is to assess functional capacity, quality of life and functioning of the autonomic nervous system in heart failure patients on beta-blocker treatment. The study hypothesis is that subjects who walk less distance, have lower quality of life and reduced heart rate variability during the six minute walk test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure and its treatment result in symptoms such as pulmonary or systemic congestion causing impairment to the effort, psychological and social commitment, and impact on quality of life.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 38405320
        • Amelio Marques Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients routinely treated at the Amelio Marques Clinic, Hospital de Clínicas, Federal University of Uberlandia, who have scheduled a visit during the period of study and attends the criterias of the study will be included.

The sample will be a convenience, and included all patients who meet the study criteria.

The control group included healthy participants with the same gender and age of the chronic heart failure group.

Description

Inclusion Criteria:

  • Both sexes
  • Different etiologies of Heart Failure
  • Functional class I - III (NYHA)
  • Left ventricular ejection fraction (LVEF) ≤ 50%
  • No history of previous cardiac surgery
  • In return for medical evaluation at the Amelio Marques Clinic, Hospital de Clinicas, Federal University of Uberlândia scheduled for the period from October 2012 to January 2013
  • Clinical stability observed by: heart rate, respiratory rate, blood pressure and arterial oxygen saturation

Exclusion Criteria:

  • Bad cognition compromising the understanding of tests
  • Physical disability that compromise the performance in walk test
  • Aortic aneurysm or any aortic deformity
  • Patients with signs or symptoms of transient myocardial ischemia with angina pectoris and/or class IV by the Canadian Cardiovascular Society Classification
  • Anomalous pressure behavior with hypertension > 180/100 mmHg
  • Orthostatic hypotension (decrease > 15 mmHg ) with symptoms
  • Arrhythmia with presence of complex ventricular extra systoles
  • Tachycardia sinus at rest (HR > 120 beats/min)
  • Atrioventricular block of 2nd or 3rd degree
  • Subjects with pacemakers or implantable cardioverter-defibrillator (ICD)
  • Functional class IV by the New York Heart Association
  • Chronic organ dysfunction such as renal failure, respiratory or liver disease
  • Active neoplasia over the past five years
  • Commitment as general weakness, fever, other limiting factors (psychological, musculoskeletal)
  • Feeling sick before the beginning of the Six minute walk test: intolerable angina or dyspnea, cramps in legs, staggering gait, excessive sweating (diaphoresis), pallor or ashen skin or SpO2 below 85%
  • Voluntary desire of the patient to withdraw from research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Heart failure group
All chronic heart failure group participants will perform two walk tests at the same day, with a heart rate monitor, and answer questionnaires about their perception of quality of life. Tests will be conducted on a single day, without follow up of patients. The six minute walk test will be performed according the American Thoracic Society Statement (2002).
Other: Six minute walk test
If patients meet the criteria of the study, their data will be collected and will be interviewed to fill the Minnesota Living with Heart Failure Questionnaire (MLHFQ). They then will be taken to the hallway to perform the six minute walk test monitored with a heart rate monitor (Polar RS800 CX). After the test there will be a break of 20 to 30 minutes before repeating the walk test. During rest time, the patient will answer the general health survey questionnaire: Medical Outcome Study 36-item Short-Form Health Survey (SF-36).
Other Names:
  • SF-36
  • MLHFQ
  • Heart rate variability (Polar RS800 CX)
Control Group
All control group participants will perform two walk tests at the same day, with a heart rate monitor, and answer questionnaires about their perception of quality of life. Tests will be conducted on a single day, without follow up of patients. The six minute walk test will be performed according the American Thoracic Society Statement (2002).
Other: Six minute walk test
If patients meet the criteria of the study, their data will be collected and will be interviewed to fill the Minnesota Living with Heart Failure Questionnaire (MLHFQ). They then will be taken to the hallway to perform the six minute walk test monitored with a heart rate monitor (Polar RS800 CX). After the test there will be a break of 20 to 30 minutes before repeating the walk test. During rest time, the patient will answer the general health survey questionnaire: Medical Outcome Study 36-item Short-Form Health Survey (SF-36).
Other Names:
  • SF-36
  • MLHFQ
  • Heart rate variability (Polar RS800 CX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum distance walked
Time Frame: During six minute walk test
The six minute walk test will be performed twice by each patient, at the same day. The collection period will extend until the sample is complete. This is an observational study because there is no follow up and reassessment of patients.
During six minute walk test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Study Chair: Celia R Lopes, PhD, Federal University of Uberlândia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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