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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01155297
First received: June 29, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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 Intervention
Kidney Failure, Chronic
Resistance Training
Treatment
Behavioral: Physical training
Behavioral: Stretching and metabolic exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 68
Study Start Date: June 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 29, 2010
Last Updated: June 29, 2010
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014