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

This study is currently recruiting participants.
Verified November 2012 by Federal University of Uberlandia
Sponsor:
Information provided by (Responsible Party):
Débora Lara Zuza Scheucher, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT01736137
First received: November 26, 2012
Last updated: August 14, 2013
Last verified: November 2012
  Purpose

The purpose of this study is to assess functional capacity, quality of life and functioning of the autonomic nervous system in patients with heart failure. 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.


Condition Intervention
Heart Failure
Autonomic Nervous System Imbalance
Heart Rate and Rhythm Disorders
Quality of Life
Other: Six minute walk test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Six Minute Walk Test, Heart Rate Variability and Quality of Life in Heart Failure

Resource links provided by NLM:


Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • Maximum distance walked [ Time Frame: During six minute walk test ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Heart failure group
All 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:
  • MLHFQ
  • SF-36
  • Heart rate variability (Polar RS800 CX)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736137

Contacts
Contact: Débora LZ Scheucher 34 9204-1538 ext 55 debs.fisio@gmail.com

Locations
Brazil
Amelio Marques Clinic Recruiting
Uberlandia, Minas Gerais, Brazil, 38405320
Contact: Débora LZ Scheucher    55-34-9204-1538    debs.fisio@gmail.com   
Contact: Celia R Lopes, PhD    55-34-3218-2910    celialopes@faefi.ufu.br   
Principal Investigator: Debora LZ Scheucher         
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Study Chair: Celia R Lopes, PhD Federal University of Uberlandia
  More Information

Publications:

Responsible Party: Débora Lara Zuza Scheucher, Physiotherapist, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT01736137     History of Changes
Other Study ID Numbers: dont have
Study First Received: November 26, 2012
Last Updated: August 14, 2013
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
Heart failure
Autonomic Nervous System
Heart rate
Quality of life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014