Postoperative physiotherapy in kidney transplantation.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-65g6xz
• Date of registration: 04/01/2012
• Primary sponsor: Universidade Federal de São Paulo - UNIFESP - Brazil
• Public title: Postoperative physiotherapy in kidney transplantation.
• Scientific title: The impact of physiotherapy on exercise tolerance, muscle strength, pulmonary function and quality of life in kidney transplant patients six months after surgery.
• Date of first enrolment: 01/02/2011
• Target sample size: 60
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-65g6xz/
• Study design: Clinical trial, two-arms, randomized and open.

Countries of recruitment

Brazil

Contacts

• Name: Luciana Chiavegato
• Affiliation: Universidade Federal de São Paulo - UNIFESP

• Name: Leonardo Costa
• Affiliation: Universidade Cidade de São Paulo - UNICID

Key inclusion & exclusion criteria

Inclusion criteria: Patients undergoing living donor kidney transplant; Any sex; Age 18 to 60 years.
Exclusion criteria: Age 18 to 60 years; Any sex; Time of invasive mechanical ventilation longer than 24 hours post-transplant; Stay in the intensive care unit, ICU, for a period longer than 48 hours; Cognitive interfering in the techniques to be instituted; Pulmonary and cardiovascular complications in 24 hours after renal transplantation, such as pneumonia, pneumothorax, myocardial infarction, unstable angina, deep vein thrombosis and / or pulmonary embolism; Patients who underwent surgical intervention; Patients who present contraindications for testing the six-minute walk: orthopedic impairments, unstable angina and acute myocardial infarction in the last month, heart rate (HR) greater than 120 bpm at rest, systolic blood pressure greater than 180 mmHg or diastolic greater than 100 mmHg; Intraoperative death.

Age minimum: 18Y
Age maximum: 60Y
Gender: -

Health Condition(s) or Problem(s) studied

Chronic renal failure, kidney transplant, exercise tolerance, muscle strength, lung function, quality of life.
E02.870.500

Intervention(s)

Control Group was composed of 30 individuals, where the guidelines were taken once a day by a physiotherapist, in the afternoon. Consisted of: general guidelines as to the breathing exercises associated with elevation of upper limbs, need and importance of walking the day of cough. Intervention Group also comprises 30 individuals, where the protocol was performed once a day in the afternoon, with supervision and guidance of a physiotherapist. Consisted of: respiratory therapy and motor that will consist of general guidelines (same as the control group), breathing exercises associated with elevation of upper limbs (3 sets of 10 repetitions) resistance exercise for upper limbs using dumbbells (3 sets of 10 repetitions) walk down the hall with supervision, up and down stairs (1 flight of stairs with a gradual increase).

Primary Outcome(s)

- Increased muscle strength, will be performed by measuring the maximal inspiratory pressure and maximal expiratory pressure. For this measurement will be used a digital manometer MVD-300 GlobalMedia brand.
- Increased of peripheral muscle strength: a tool for estimating the force of maximal voluntary isometric contraction of the upper dynamometer EMG is a 100-U1, brand EMG System of Brazil.
- Improvement in pulmonary function: will be performed by spirometry according to technical criteria proposed by the Brazilian guidelines for pulmonary function tests, using a MIR spirometer (Medical International Research) Spirobank G model approved by the FDA (Food and Drug Administration ) and certified by the ATS (American Thoracic Society), previously calibrated by the manufacturer.
- Performance testing of six-minute walk: Testing will be done using the six-minute walk, according to the procedures described by the ATS (2002).
- Score the quality of life questionnaire: to be implemented the SF-36, which is an instrument with translation and cultural validation in Brazil.

Secondary Outcome(s)

- Time of dialysis;
- Days of hospitalization.

Secondary ID(s)

0271/11

Source(s) of Monetary Support

Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos - Brazil

Secondary Sponsor(s)

Universidade Cidade de São Paulo - UNICID - Brazil