Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy (RACCRPPT)

December 6, 2015 updated by: Bruno Martinelli, Universidade Federal de Sao Carlos

The Relationship Between Abdominal Circumference and Cardiorespiratory Repercussions in Hospitalized Patients Submitted to Physical Therapy

The purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy.

Study Overview

Detailed Description

The physiotherapist assessment will consist of anthropometry (body mass index, abdominal circumference, adipometer); chest inspection and palpation, vital signs (blood pressure, heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and pulmonary volume and capacity). This will be a quasi-experimental study. Patients will be divided into four groups according to waist circumference (increased or not, with respect to cardiovascular risk) and respiratory disorders (obstructive and restrictive). After this assessment, chest physical therapy will begin according to the protocol for obstructive and restrictive respiratory disorders. The treatment will have an average duration of 30 minutes. At the end of treatment (single session) the patient will be assessed again after five and thirty minutes.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Bauru, SP, Brazil, 17051-000
        • Hospital Estadual Manoel de Abreu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients (> 18 years old), clinical stability characterized by axillary body temperature below 38 ° C, hemoglobin higher than 7 g / dL, oxygen saturation by pulse oximetry greater than or equal to 88%, mean arterial pressure (MAP) greater than 70 or less than 120 mm Hg, heart rate between 50 bpm to 140 bpm ; ability to understand, carry out the commands appropriately for evaluative tests, with the Glasgow Coma Scale score greater than 8, locomotor integrity of the lower limbs, spontaneous breathing, lack of hospital physiotherapy during hospitalization, prescription for respiratory therapy; bronchodilator, if applicable four hours before intervention.

Exclusion Criteria:

  • inadequate perform to the maneuvers of the evaluation (e.g. spirometry), hemodynamic instability, thoracic dermal injury, disabling orthopedic complications that compromise the techniques of assessment and intervention, lymphedema of the trunk; sudden weight gain with edema in limbs, ascites, nephrotic syndrome, congestive heart failure, liver cirrhosis, erysipelas, deep vein thrombosis, heart bypass, heart transplantation, arrhythmias, atrioventricular block, severe dyspnea (Borg> 5), spinal cord injury, hemoptysis, osteoporosis, recent surgeries, coagulopathy, bronchopleural fistula, subcutaneous emphysema, presence of diabetes mellitus associated with cardiac autonomic dysfunction, bronchoconstriction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obstructive increased AC

Patient with obstructive respiratory disease with increased abdominal circumference.

chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough.

The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.
Other Names:
  • Chest physical therapy
Experimental: Obstructive disfunction with normal AC

Patients with obstructive respiratory disease with normal abdominal circumference.

Patient with obstructive respiratory disease with increased abdominal circumference.

chest physiotherapy. Chest physiotherapy airway clearance modality. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest wall (compression, vibration) and cough.

The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.
Other Names:
  • Chest physical therapy
Experimental: Restrictive increased AC

Patients with restrictive respiratory disease with increased abdominal circumference. chest physiotherapy chest wall expansion.

The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry.

chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).
Other Names:
  • Chest physiotherapy
Experimental: Restrictive disfunction with normal AC

Patients with restrictive respiratory disease with normal abdominal circumference.

Chest physiotherapy chest wall expansion. The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression) and incentive spirometry.

chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).
Other Names:
  • Chest physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in spirometric measures.
Time Frame: Baseline, five and thirty minutes.
The spirometry is used to assess chest volume and capacity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second.
Baseline, five and thirty minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.
Time Frame: Baseline, five and thirty minutes.

The pulse oxymetry or pulse oximeter is used to measure peripheral oxygen saturation.

The arterial blood pressure (systolic and diastolic) will be measured by sphygmomanometer to follow the displacement.

Baseline, five and thirty minutes.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of heart rate variability before/after chest physiotherapy. Comparison of thoracoabdominal perimetry before/after chest physiotherapy.
Time Frame: Baseline, five and thirty minutes.

Heart rate variability has become the conventionally accepted term to describe variations of both instantaneous heart rate and intervals (time domain).

Thoracoabdominal perimetry consists of a set of measurements of thoracic and abdominal circumferences during respiratory movements, and it aims at quantifying the thoracoabdominal mobility.

Baseline, five and thirty minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bruno Martinelli, Me, Ufscar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 6, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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