Effect of PT on QL, FC, PWV and Biochemical Markers in CRF on Conservative Treatment

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Introduction: Chronic Kidney Disease (CKD) is considered an important public health problem, with prevalence of 9.6% in our population. The CKD has as main symptoms fatigue, muscle weakness and poor exercise tolerance, which directly contribute to physical inactivity and low mobility, increasing the risk of morbidity and mortality in CKD patients with significant impact on quality of life of these patients. Thus, patients with CKD have poor quality of life, high incidence of cardiovascular diseases, high prevalence of endothelial dysfunction, the consequent increase in arterial stiffness and serum concentration of asymmetric dimethylarginine (ADMA). It is believed that the conditioning of these patients may reduce cardiovascular risks and improve the quality of life. Aim of the study: Evaluate the impact of exercise training in relation to functional capacity, quality of life, pulse wave velocity and ADMA in patients with CKD on dialysis. Materials and methods: Is a randomized controlled study, with 34 CKD patients on conservative treatment, divided into control group (with stretching exercises and metabolic exercises) and training group, those undergoing physical training, aerobic and resistance during six months. Before and after exercise training, patients will be assessed using the SF-36 and IPAQ. Also be held assessment of pulse wave velocity, measurement of serum ADMA and spirometry testing. Statistical analysis consisted of t test for independent data or chi-square when appropriate.

Condition or disease	Intervention/treatment	Phase
Kidney Failure, Chronic; Resistance Training; Treatment	Behavioral: Physical training; Behavioral: Stretching and metabolic exercises	Not Applicable

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	68 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Supportive Care
Official Title:	Effect of Physical Training on Quality of Life, Functional Capacity, Pulse Wave Velocity and Biochemical Markers in Patients With Chronic Renal Failure on Conservative Treatment
Study Start Date :	June 2010
Estimated Primary Completion Date :	May 2011
Estimated Study Completion Date :	November 2011

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: Control Group; At the control group, with 34 subjects, will be performed stretching and metabolic exercises. This group will make the assessments before and the reassessments after the end of the program.	Behavioral: Stretching and metabolic exercises; At the control group will be performed stretching and metabolic exercises and will make the assessments and the reassessments after the end of the program.; Other Names: Pumping exercises; Control Group
Active Comparator: Training group; At the training group, with 34 subjects, will be performed stretching, physical training and resistance. This group will make the assessments before and the reassessments after the end of the program.	Behavioral: Physical training; The exercise program will be held three times a week and will have three stages: local and global stretching, aerobic exercise for 30 minutes ( with 50 and 60% of maximal heart rate) and strength training. The strength training will be done after assessment of one repetition maximum (1RM) and the prescription will be made with 50% load of 1RM, where the patient will hold three sets of 10-12 repetitions. Reassessments will be conducted monthly for readjustment of the charges. The duration of the training protocol will be six months. After completing this exercise program, patients will undergo a reassessment repeating the ET and reapplication of the SF-36, redone the collection of ADMA serum concentration.; Other Names: Exercise Training; Intervention group

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The impact of exercise training in relation to functional capacity, quality of life, pulse wave velocity and ADMA in patients with CKD on dialysis [ Time Frame: 6 months ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Patients over 18 years, diagnosed with Chronic Kidney Disease, stages II to IV, and that shows contraindications to exercise training

Exclusion Criteria: Patients unable to understand the procedures that will be performed, previous diagnosis of coronary artery disease, uncontrolled chronic hypertension (BP ≥ 150 x 100 mm Hg), ET positive for cardiac ischemia, patients with cancer, liver failure or chronic or acute infection.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Viviana Silva, Graduate	0055 1481565222	viviana_rugolo@yahoo.com.br
Contact: Luis Cuadrado, Doctor	0055 1438116213

Locations

Brazil
State University of São Paulo "Júlio de Mesquita Filho", Medicine School of Botucatu	Not yet recruiting
Botucatu, São Paulo, Brazil
Contact: Viviana Silva, Graduate viviana_rugolo@yahoo.com.br
Contact: Luis Cuadrado, Doctor 0055 1438116213
Principal Investigator: Viviana Silva, Graduate

Sponsors and Collaborators

UPECLIN HC FM Botucatu Unesp

Investigators

Principal Investigator:	Viviana Silva, graduate	State University of São Paulo "Júlio de Mesquita Filho", Medicine School of Botucatu
Study Director:	Luis Cuadrado, Doctor	State University of São Paulo "Júlio de Mesquita Filho", Medicine School of Botucatu

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Viviana Rugolo Oliveira e Silva, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:	NCT01155297 History of Changes
Other Study ID Numbers:	upeclin/HC/FMB-Unesp-45
First Posted:	July 1, 2010
Last Update Posted:	July 1, 2010
Last Verified:	June 2010

Keywords provided by UPECLIN HC FM Botucatu Unesp:

Quality of Life; Biological Markers; Renal Insufficiency	Resistance Training; Exercise; Chronic Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic