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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736137
• Other study ID #: dont have
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: August 5, 2014
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: August 2014
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance
• Heart Failure
• Heart Rate and Rhythm Disorders
• Quality of Life

Intervention

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).

Locations

Country	Name	City	State
Brazil	Amelio Marques Clinic	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (24)

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Opasich C, Pinna GD, Mazza A, Febo O, Riccardi R, Riccardi PG, Capomolla S, Forni G, Cobelli F, Tavazzi L. Six-minute walking performance in patients with moderate-to-severe heart failure; is it a useful indicator in clinical practice? Eur Heart J. 2001 Mar;22(6):488-96. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum distance walked	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	No