Physiotherapy in patients of abdominal surgery.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-73vbv8
• Primary sponsor: Pontifícia Universidade Católica de Campinas - Brazil
• Public title: Physiotherapy in patients of abdominal surgery.
• Scientific title: Effects of preoperative physiotherapy in cardiorespiratory conditions and physical functioning of patients undergoing upper abdominal surgery.
• Date of first enrolment: 27/10/2010
• Target sample size: 30
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-73vbv8/
• Study design: Clinical trial, randomised, with 2 arms.

Countries of recruitment

Brazil

Contacts

• Name: Silvia Soares
• Affiliation: Pontifícia Universidade Católica de Campinas

• Name: Silvia Soares
• Affiliation: Pontifícia Universidade Católica de Campinas

Key inclusion & exclusion criteria

Inclusion criteria: Patients with over 40 years of age.
Scheduling of upper abdominal surgery elective (including surgery of esophagus, stomach or biliary tract surgery).
Patients in preoperative elective period, at least 15 days and up to 21 days in advance of surgery.
Physical and mental conditions that permit the evaluation of pulmonary function and walking test acceptable before surgery.
Patients who signed an informed consent forms.

Exclusion criteria: Patients with cerebrovascular or neuromuscular disease.
Patients on immunosuppressive therapy before surgery.
Prior pulmonary surgery history.
Patients that had previously undergone surgery of the esophagus, stomach or biliary tract.
Cardivascular instability.
Patients undergoing physiotherapy in the eight weeks before inclusion in the study.


Age minimum: 40Y
Age maximum: 90Y
Gender: -

Health Condition(s) or Problem(s) studied

Patients in the elective preoperative of: esophageous surgery, stomach surgery and billiar tract surgery.
Q65.070

Intervention(s)

The patients will be allocated in the preoperative period to: intervention group (Arm 1) or control group (Arm 2). Arm 1: Patients are undergoing preoperative physiotherapy for 2 weeks (minimum) to 3 weeks (maximum) before surgery. The preoperative physiotherapy includes respiratory muscle training (15minutes), walking (10minutes), deep respiratory exercise, huff, cough and global exercises (30minutes), twice a week, with the physiotherapist. Moreover, it is recommended the respiratory muscle training (15minutes) and walk (10 minutes), at home, four times a week, without supervision (in different days of supervisioned physiotherapy). Arm 2: Preoperative physiotherapy is not performed in the subjects.
Postoperative physiotherapy: all patients are undergoing the same protocol of supervisioned physiotherapy, once a day, in the first seven days after surgery (or until discharge, if hospitalization time less than seven days after the operation). The protocol (45minutes) includes: deep respiratory exercise, huff, cough, arms exercises, legs exercises, exit of bed and walk (around 5 to 10 minutes). It is recommended that the patient repeat the postoperative exercise protocol , once again the day, without the presence of the physiotherapist.

Primary Outcome(s)

Functional status as assessed using the functional independence measure (FIM). The score expressed: total dependece (18), modified dependence (19-60), modified independence (61-103) or total independence (104-126). Timepoint: Baseline (at inclusion in the study), 24 hours before surgery, within first 24 hours after surgery, seven days after surgery (or at discharge, if hospitalization time less than seven days after the operation) and thirty days after surgery.

Physical-functional performance evaluated with six minutes walk test. Distance walked expressed in absolute (meters) and % of predicted. Timepoint: Baseline (at inclusion in the study), 24 hours before surgery, seven days after surgery (or at discharge, if hospitalization time less than seven days after the operation) and thirty days after surgery.

Pulmonary function (spirometry) including vital capacity, forced vital capacity, forced expiratory volume in 1 second, expiratory forced flow peak . Measures expressed in absolute (liters or liters/second) and % of predicted. Timepoint: Baseline (at inclusion in the study), 24 hours before surgery, within first 24 hours after surgery, seven days after surgery (or at discharge, if hospitalization time less than seven days after the operation) and thirty days after surgery.

Respiratory muscle endurance using inspiratory incremental effort test with linear loading device. Value expressed in absolute (cmH2O). Timepoint: Baseline (at inclusion in the study), 24 hours before surgery, within first 24 hours after surgery, seven days after surgery (or at discharge, if hospitalization time less than seven days after the operation) and thirty days after surgery.

Respiratory muscle strength as assessed using maximum inspiratory mouth pressure (MIP) and maximum expiratory mouth pressure (MEP). Values expressed in absolute (cmH2O) and % of predicted. Timepoint: Baseline (at inclusion in the study), 24 hours before surgery, within first 24 hours after surgery, seven days after surgery (or at discharge, if hospitalization time less than seven days after the operation) and thirty days after surgery.

Secondary Outcome(s)

Length of stay of patients in hospital according to medical records, expressed in days. Timepoint: Thirty days after surgery.

Secondary ID(s)

1029-09

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - FAPESP - Brazil

Secondary Sponsor(s)

Silvia Maria de Toledo Piza Soares - Brazil