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Completed

NCT Number: NCT01736137

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amelio Marques Clinic

Uberlândia, Minas Gerais, 38405320, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Six Minute Walk Test

Other

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2012
Registry last updated
Aug 7, 2014

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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