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

Federal University of Uberlandia

Status: Completed

Conditions: Autonomic Nervous System Imbalance; Quality of Life; Heart Failure; Heart Rate and Rhythm Disorders

Treatments: Other: Six minute walk test

Study type: Observational

Funder types: Other

Identifiers

NCT01736137

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

17 participants in 2 patient groups

Chronic Heart failure group

Description:

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).

Treatment:

Other: Six minute walk test

Control Group

Description:

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).

Treatment:

Other: Six minute walk test