Impact of exercise in ovseweight nondialyis dependent chronic kidney disease patients.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9jjj2n
• Date of registration: 09/04/2012
• Primary sponsor: Universidade Federal de São Paulo - São Paulo, SP, Brazil
• Public title: Impact of exercise in ovseweight nondialyis dependent chronic kidney disease patients.
• Scientific title: Home-based vs in center aerobic exercise: impact on functional capacity, nutritional status and cardiometabolic parameters in overweight nondialysis dependent chronic kidney disease patients
• Date of first enrolment: 05/01/2011
• Target sample size: 60
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9jjj2n/
• Study design: Outcome, prospective randomized controlled, parallel, with 3 arms clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Lilian Valle
• Affiliation: Fundação Oswaldo Ramos

• Name: Lilian Valle
• Affiliation: Fundação Oswaldo Ramos

Key inclusion & exclusion criteria

Inclusion criteria: Sedentary individuals with chronic kidney disease stages 3 or 4 disease;
Both genders;
Age between 30 and 65 years;
Overweight (BMI> 25 kg/m2;
With a negative stress test.
Exclusion criteria: Patients with chronic obstructive pulmonary disease, class IV heart failure, myocardial infarction within the last 6 months, decompensated hypertension (systolic blood pressure> 180 mmHg or diastolic> 110 mmHg in the last 6 months), uncontrolled cardiac arrhythmia, decompensated diabetes mellitus (glycated hemoglobin> 8.0%), unstable angina, infectious processes in the last 3 weeks;
Use of erythropoietin or beta-blocker medication or with hemoglobin <11g/L.

Age minimum: 30Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

Chronic kidney disease, overweight patients(BMI>25 kg/m2)
C12.777.419.780.750.500
C18.654.726.500

Intervention(s)

Patients will be randomly assigned to perform the training program in center (n=20)or home-based (n=20). The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.
It will also constituted a control group (n = 20) remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.

Primary Outcome(s)

Increase of 3ml/kg/min in the oxigen uptake in the home-based exercice group.
The peak oxigen consumption will be determined by the ergoespirometric test.

Secondary Outcome(s)

A 2% reduction in the visceral abdominal fat of patients in the home-based exercise group.
Abdominal fat will be assessed by computed tomography.

An average improvement of 10% in the fuctional capacity tests in the home-based excercise group.
The tests are: 6 minutes walk test, 2 minutes step test, time up and go and sit stand test.

Secondary ID(s)

0305.0.174.000-09

0921/09

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - Sã Paulo, SP, Brazil

Secondary Sponsor(s)

Fundação Oswaldo Ramos - São Paulo, SP, Brazil