Effects of mild versus moderate training in patients with heart failure.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-3ypm3f
• Date of registration: 18/07/2011
• Primary sponsor: Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG - Brazil
• Public title: Effects of mild versus moderate training in patients with heart failure.
• Scientific title: Comparison of the effects of mild versus moderate aerobic training on the inflammatory markers, on oxidative stress and quality of life, in patients with chronic heart failure – a randomized clinical trial.
• Date of first enrolment: 01/09/2011
• Target sample size: 48
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-3ypm3f/
• Study design: Randomized clinical trial, 3-arm, prospective, open and parallel.

Countries of recruitment

Brazil

Contacts

• Name: Dayane Montemezzo
• Affiliation: Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG

• Name: Giane Ribeiro-Samora
• Affiliation: Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG

Key inclusion & exclusion criteria

Inclusion criteria: Patients with diagnosis of heart failure for at least six months, clinically stable for at least two months before this study.
Left ventricular ejection fraction < 45%.
Aging between 25 and 59 years old.
Body mass index (BMI) < 30 kg/m2.
Stage C of the guidelines from the American College of Cardiology and American Heart Association (2005).
Classes I to III from the New York Heart Association (NYHA).
Sedentary, as defined by American College of Sports Medicine (2007).
Exclusion criteria: User of cardiac pacemaker.
Inflammatory diseases in acute phase;
Renal insufficiency.
Orthopedic or neurological impairments which limit the exercise performance.
History of respiratory disease, unstable angina, uncontrolled arrhythmias or peripheral obstructive arterial disease.

Age minimum: 25Y
Age maximum: 59Y
Gender: -

Health Condition(s) or Problem(s) studied

Heart failure, inflammation, oxidative stress
C14.280.434
C23.550.470
GO3.495.710

Intervention(s)

Two training protocols isocaloric:
ARM 1: physical training of moderate intensity, performed on a treadmill, in heart rate corresponding to 60% of VO2 peak, lasting 30 minutes, 3 times per week, for 12 weeks.
ARM 2: physical training of mild intensity, performed on a treadmill, in heart rate corresponding to 40% of VO2 peak, lasting 45 minutes, 3 times per week, for 12 weeks.
ARM 3: physical training of mild intensity, performed on a treadmill, in heart rate corresponding to 40% of VO2 peak, lasting 30 minutes, 3 times per week, for 12 weeks.

Primary Outcome(s)

Inflammatory markers: interleukin-6 (IL-6) and soluble tumor necrosis factor alpha receptor-1 (sTNFR1), measured by ELISA method.

Oxidative stress: malondialdehyde, enzymes superoxide dismutase, catalase and glutathione peroxidase, by enzymatic methods.

Quality of life (scores of the Minnesota Living with Heart Failure Questionnaire).

Secondary Outcome(s)

Results of cardiopulmonary exercise test: peak oxygen uptake (VO2peak), oxygen pulse (VO2/HR), anaerobic threshold (AT), markers of ventilatory efficiency (eg, the VE/VCO2 slope and oxygen uptake efficiency slope - OUES and exercise oscillatory ventilation - EOV).

Six-minute walk test (distance).

Secondary ID(s)

0050.0.203.000-09

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de Minas Gerais - Fapemig - Brazil

Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq - Brazil

Secondary Sponsor(s)

Ambulatório de Insuficiência Cardíaca - UFMG - Brazil

Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq - Brazil

Fundação de Amparo à Pesquisa do Estado de Minas Gerais - Fapemig - Brazil