Influence of an exercise session and a period of physical training on the cardiovascular system of patients with intermittent claudication

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7m3d8w
• Date of registration: 01/02/2012
• Primary sponsor: Escola de Educação Física e Esporte da Universidade de São Paulo - Brazil
• Public title: Influence of an exercise session and a period of physical training on the cardiovascular system of patients with intermittent claudication
• Scientific title: Acute and Chronic Cardiovascular Responses to Exercise in Subjects with Intermittent Claudication
• Date of first enrolment: 01/03/2010
• Target sample size: 30
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7m3d8w/
• Study design: Randomized controlled trial, not blinded, paralel design with 2 arms

Countries of recruitment

Brazil

Contacts

• Name: Claudia Forjaz
• Affiliation: Escola de Educação Física e Esporte da Universidade de São Paulo

• Name: Cláudia Forjaz
• Affiliation: Escola de Educação Física e Esporte da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Men
Aged between 50 and 80 years
Ankle-brachial index lower than 0.9
Peripheral artery disease - level II
Able to walk on a treadmill for at least 2 min at 3.2 km/h
Absence of obesity
Systolic and diastolic blood pressures lower than 160 and 105 mmHg, respectively
Absence of bypass surgery or angioplasty for at least one year
Not using beta-blockers, non-dihydropyridine calcium channel antagonists or peripheral vasodilators
Absence of leg amputation
Absence of orthopedic problems that contraindicates walking.
Exclusion criteria: Presence of complex arrhythmias and/or ischemia during exercise
Fasting glycemia greater than 250mg/dl
Presence of autonomic dysfunction

Age minimum: 50Y
Age maximum: 80Y
Gender: M

Health Condition(s) or Problem(s) studied

Intermittent Claudication
C14.907.137.126.669

Intervention(s)

Randomized groups: control and training.
Control: Stretching, 2x/week, 30 min/day, 12 weeks
Training: Walking, 2x/week, 15 sets of 2 min exercise/2 min pause, intensity: heart rate of pain threshold, 12 weeks

Primary Outcome(s)

Autonomic modulation - evaluated by the measurement of heart rate and blood pressure variabilities (spectral analysis) performed before and after acute session (control or walking) and at the beginning and end of training.

Hemodynamics - evaluated by the measurement of blood pressure (auscultatory and ambulatory), cardiac output (CO2 rebreathing)and heart hate (ECG) performed before and after acute session (control or walking) and at the beginning and end of training. Systemic vascular resistance and stroke volume will be calculated.

Vascular function - evaluated by the measurement of baseline blood flow and its response to the reactive hyperemia maneuver (venous occlusion pletismography) performed before and after acute session (control or walking) and at the beginning and end of training.

Secondary Outcome(s)

Exercise capacity - evaluated by an maximal treadmill exercise test, achieving peak oxygen uptake, initial claudication distance, and total walking distance

Secondary ID(s)

1179/09

CEP39 - 2008/55

Source(s) of Monetary Support

Coordenadoria de Aprimoramento Pessoal - Brazil

Fundação de Amparo à Pesquisa do Estado de São Paulo - Brazil

Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil

Secondary Sponsor(s)

Ambulatório de Claudicação Intermitente do Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo - Brazil

Programa de Promoção de Envelhecimento Saudável do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Brazil