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

Completed

• Conditions: Heart Failure; Autonomic Nervous System Imbalance; Heart Rate and Rhythm Disorders; Quality of Life
• Interventions: Other: Six minute walk test

• Registration Number: NCT01736137
• Lead Sponsor: Federal University of Uberlandia

Brief Summary

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Heart failure group	Six minute walk test	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).
Control Group	Six minute walk test	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).

Primary Outcome Measures

Name	Time	Method
Maximum distance walked	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.

Trial Locations

Locations (1)

Amelio Marques Clinic; 🇧🇷 Uberlandia, Minas Gerais, Brazil