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

NCT01155297 | Unknown DMC

• 1 other identifier: upeclin/HC/FMB-Unesp-45
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic; Resistance Training; Treatment

Keywords

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

Outcome Measures

Primary Outcomes (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

  6 months

Study Arms (2)

Control Group

SHAM COMPARATOR

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

Training group

ACTIVE COMPARATOR

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

Interventions

Physical training BEHAVIORAL

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.

Also known as: Exercise Training, Intervention group

Training group

Stretching and metabolic exercises BEHAVIORAL

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.

Also known as: Pumping exercises, Control Group

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

State University of São Paulo "Júlio de Mesquita Filho", Medicine School of Botucatu

Botucatu, São Paulo, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency; Motor Activity

Interventions

Physical Conditioning, Human; Exercise; Control Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Viviana Silva, graduate

  State University of São Paulo "Júlio de Mesquita Filho", Medicine School of Botucatu

  PRINCIPAL INVESTIGATOR

• Luis Cuadrado, Doctor

  State University of São Paulo "Júlio de Mesquita Filho", Medicine School of Botucatu

  STUDY DIRECTOR

Central Study Contacts

Viviana Silva, Graduate

CONTACT

0055 1481565222; viviana_rugolo@yahoo.com.br

Luis Cuadrado, Doctor

CONTACT

0055 1438116213

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 1, 2010

Record last verified: 2010-06

Locations

BR (1)