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

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ClinicalTrials.gov Identifier: NCT01155297

Recruitment Status : Unknown

Verified June 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was: Not yet recruiting

First Posted : July 1, 2010

Last Update Posted : July 1, 2010

Sponsor:

Information provided by:

UPECLIN HC FM Botucatu Unesp

Study Description

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


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Exercise and Physical Fitness Health Checkup Kidney Failure

U.S. FDA Resources

Arms and Interventions

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

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

Primary Outcome Measures :

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155297

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


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 Key Record Dates
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

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