Heart FailureNCT01736137
Evaluation of the Six Minute Walk Test and Other Instruments in Heart Failure
An observational study of Heart Failure and Autonomic Nervous System Imbalance, run by Federal University of Uberlandia at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Autonomic Nervous System Imbalance, Heart Rate and Rhythm Disorders
- What is being tested?
- Six minute walk test
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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. The control group included healthy participants with the same gender and age of the chronic heart failure group.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Six Minute Walk Test, Heart Rate Variability and Quality of Life in Heart Failure Patients on Beta-blocker Treatment
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.
Read the 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.
- Conditions
- Heart Failure, Autonomic Nervous System Imbalance, Heart Rate and Rhythm Disorders, Quality of Life
- Being tested
- Six minute walk test
- Keywords
- Heart failure, Autonomic Nervous System, Heart rate, Quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six minute walk testOther
Also called MLHFQ, SF-36, Heart rate variability (Polar RS800 CX)
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).
| Study group | Role | What they receive |
|---|---|---|
| Chronic Heart failure group | 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). Receives: Other: Six minute walk test | |
| Control Group | 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). Receives: Other: Six minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During six minute walk test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Débora Lara Zuza Scheucher, Federal University of Uberlandia
- Investigators
- Celia R Lopes, PhD, Study chair, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736137
- Sponsor's protocol ID
- dont have
- Status last verified
- Aug 2014
- First submitted
- 26 Nov 2012
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Bocchi EA, Braga FG, Ferreira SM, Rohde LE, Oliveira WA, Almeida DR, Moreira Mda C, Bestetti RB, Bordignon S, Azevedo C, Tinoco EM, Rocha RM, Issa VS, Ferraz A, Cruz Fd, Guimaraes GV, Montera Vdos S, Albuquerque DC, Bacal F, Souza GE, Rossi Neto JM, Clausell NO, Martins SM, Siciliano A, Souza Neto JD, Moreira LF, Teixeira RA, Moura LZ, Beck-da-Silva L, Rassi S, Azeka E, Horowitz E, Ramires F, Simoes MV, Castro RB, Salemi VM, Villacorta Junior H, Vila JH, Simoes R, Albanesi F, Montera MW; Sociedasde Brasileira de Cardiologia. [III Brazilian Guidelines on Chronic Heart Failure]. Arq Bras Cardiol. 2009;93(1 Suppl 1):3-70. No abstract available. Portuguese.
PubMed 20963312Bocchi EA, Marcondes-Braga FG, Bacal F, Ferraz AS, Albuquerque D, Rodrigues Dde A, Mesquita ET, Vilas-Boas F, Cruz F, Ramires F, Villacorta H Jr, Souza Neto JD, Rossi Neto JM, Moura LZ, Beck-da-Silva L, Moreira LF, Rohde LE, Montera MW, Simoes MV, Moreira Mda C, Clausell N, Bestetti R, Mourilhe-Rocha R, Mangini S, Rassi S, Ayub-Ferreira SM, Martins SM, Bordignon S, Issa VS. [Updating of the Brazilian guideline for chronic heart failure - 2012]. Arq Bras Cardiol. 2012 Jan;98(1 Suppl 1):1-33. doi: 10.1590/s0066-782x2012001000001. No abstract available. Portuguese.
PubMed 22392082Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Reis MS, Deus AP, Simoes RP, Aniceto IA, Catai AM, Borghi-Silva A. Autonomic control of heart rate in patients with chronic cardiorespiratory disease and in healthy participants at rest and during a respiratory sinus arrhythmia maneuver. Rev Bras Fisioter. 2010 Mar-Apr;14(2):106-13. Epub 2010 May 7. English, Portuguese.
PubMed 20464168Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.
PubMed 19838469Dantas RA, Sawada NO, Malerbo MB. [Research on quality of life: review of the scientific production of public universities from the state of Sao Paulo]. Rev Lat Am Enfermagem. 2003 Jul-Aug;11(4):532-8. doi: 10.1590/s0104-11692003000400017. Portuguese.
PubMed 14748173Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, Newman AB; Cardiovascular Health Study. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003 Feb;123(2):387-98. doi: 10.1378/chest.123.2.387.
PubMed 12576356Faggiano P, D'Aloia A, Gualeni A, Brentana L, Dei Cas L. The 6 minute walking test in chronic heart failure: indications, interpretation and limitations from a review of the literature. Eur J Heart Fail. 2004 Oct;6(6):687-91. doi: 10.1016/j.ejheart.2003.11.024. No abstract available.
PubMed 15542403[I National Consensus of Cardiovascular Rehabilitation]. Arq Bras Cardiol. 1997 Oct;69(4):267-91. No abstract available. Portuguese.
PubMed 9595722Guazzi M, Dickstein K, Vicenzi M, Arena R. Six-minute walk test and cardiopulmonary exercise testing in patients with chronic heart failure: a comparative analysis on clinical and prognostic insights. Circ Heart Fail. 2009 Nov;2(6):549-55. doi: 10.1161/CIRCHEARTFAILURE.109.881326. Epub 2009 Sep 28.
PubMed 19919979Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.
PubMed 3978515Moura LZ, Guimaraes GV, Pires PV, Cruz F, Stopa G, Bocchi EA. Exercise chemosensitivity in heart failure: ventilatory, chronotropic and neurohormonal responses. Arq Bras Cardiol. 2010 Sep;95(3):381-91. doi: 10.1590/s0066-782x2010005000110. Epub 2010 Aug 13.
PubMed 20721516Opasich 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. doi: 10.1053/euhj.2000.2310.
PubMed 11237544Pinsky MR. Cardiovascular issues in respiratory care. Chest. 2005 Nov;128(5 Suppl 2):592S-597S. doi: 10.1378/chest.128.5_suppl_2.592S.
PubMed 16306058
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Six Minute Walk Test, Heart Rate Variability and Quality of Life in Heart Failure Patients on Beta-blocker Treatment
- ClinicalTrials.gov ID
- NCT01736137
- Acronym / sponsor ID
- dont have
- Conditions
- Heart Failure, Autonomic Nervous System Imbalance, Heart Rate and Rhythm Disorders, Quality of Life
- Keywords
- Heart failure, Autonomic Nervous System, Heart rate, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Heart failure group | – | Other: Six minute walk testAll 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 | – | Other: Six minute walk testAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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. The control group included healthy participants with the same gender and age of the chronic heart failure group.
Key inclusion criteria (7 listed)
- Both sexes
- Different etiologies of Heart Failure
- Functional class I - III (NYHA)
- Left ventricular ejection fraction (LVEF) ≤ 50%
- No history of previous cardiac surgery
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six minute walk testAlso: MLHFQ, SF-36, Heart rate variability (Polar RS800 CX)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 | Chronic Heart failure group, Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 20963312Bocchi EA, Braga FG, Ferreira SM, Rohde LE, Oliveira WA, Almeida DR, Moreira Mda C, Bestetti RB, Bordignon S, Azevedo C, Tinoco EM, Rocha RM, Issa VS, Ferraz A, Cruz Fd, Guimaraes GV, Montera Vdos S, Albuquerque DC, Bacal F, Souza GE, Rossi Neto JM, Clausell NO, Martins SM, Siciliano A, Souza Neto JD, Moreira LF, Teixeira RA, Moura LZ, Beck-da-Silva L, Rassi S, Azeka E, Horowitz E, Ramires F, Simoes MV, Castro RB, Salemi VM, Villacorta Junior H, Vila JH, Simoes R, Albanesi F, Montera MW; Sociedasde Brasileira de Cardiologia. [III Brazilian Guidelines on Chronic Heart Failure]. Arq Bras Cardiol. 2009;93(1 Suppl 1):3-70. No abstract available. Portuguese.
- Background: PubMed 22392082Bocchi EA, Marcondes-Braga FG, Bacal F, Ferraz AS, Albuquerque D, Rodrigues Dde A, Mesquita ET, Vilas-Boas F, Cruz F, Ramires F, Villacorta H Jr, Souza Neto JD, Rossi Neto JM, Moura LZ, Beck-da-Silva L, Moreira LF, Rohde LE, Montera MW, Simoes MV, Moreira Mda C, Clausell N, Bestetti R, Mourilhe-Rocha R, Mangini S, Rassi S, Ayub-Ferreira SM, Martins SM, Bordignon S, Issa VS. [Updating of the Brazilian guideline for chronic heart failure - 2012]. Arq Bras Cardiol. 2012 Jan;98(1 Suppl 1):1-33. doi: 10.1590/s0066-782x2012001000001. No abstract available. Portuguese.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 20464168Reis MS, Deus AP, Simoes RP, Aniceto IA, Catai AM, Borghi-Silva A. Autonomic control of heart rate in patients with chronic cardiorespiratory disease and in healthy participants at rest and during a respiratory sinus arrhythmia maneuver. Rev Bras Fisioter. 2010 Mar-Apr;14(2):106-13. Epub 2010 May 7. English, Portuguese.
- Background: PubMed 19838469Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.
- Background: PubMed 14748173Dantas RA, Sawada NO, Malerbo MB. [Research on quality of life: review of the scientific production of public universities from the state of Sao Paulo]. Rev Lat Am Enfermagem. 2003 Jul-Aug;11(4):532-8. doi: 10.1590/s0104-11692003000400017. Portuguese.
- Background: PubMed 12576356Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, Newman AB; Cardiovascular Health Study. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003 Feb;123(2):387-98. doi: 10.1378/chest.123.2.387.
- Background: PubMed 15542403Faggiano P, D'Aloia A, Gualeni A, Brentana L, Dei Cas L. The 6 minute walking test in chronic heart failure: indications, interpretation and limitations from a review of the literature. Eur J Heart Fail. 2004 Oct;6(6):687-91. doi: 10.1016/j.ejheart.2003.11.024. No abstract available.
- Background: PubMed 9595722[I National Consensus of Cardiovascular Rehabilitation]. Arq Bras Cardiol. 1997 Oct;69(4):267-91. No abstract available. Portuguese.
- Background: PubMed 19919979Guazzi M, Dickstein K, Vicenzi M, Arena R. Six-minute walk test and cardiopulmonary exercise testing in patients with chronic heart failure: a comparative analysis on clinical and prognostic insights. Circ Heart Fail. 2009 Nov;2(6):549-55. doi: 10.1161/CIRCHEARTFAILURE.109.881326. Epub 2009 Sep 28.
- Background: PubMed 3978515Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia R Lopes, PhD study chair
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Autonomic Nervous System Imbalance, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum distance walked (time frame: During six minute walk test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736137, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.