Back to resultsAbdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy (RACCRPPT)
Primary Purpose
Obesity, Abdominal, Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Chest physiotherapy chest wall expansion
Chest physiotherapy airway clearance modality
Sponsored by
About this trial
This is an interventional basic science trial for Obesity, Abdominal focused on measuring Physical Therapy Modalities, Respiration Disorders, Respiratory Therapy
Eligibility Criteria
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.
Sites / Locations
- Hospital Estadual Manoel de Abreu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Obstructive increased AC
Obstructive disfunction with normal AC
Restrictive increased AC
Restrictive disfunction with normal AC
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in spirometric measures.
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.
Secondary Outcome Measures
Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.
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.
Full Information
NCT ID
NCT02217423
First Posted
August 12, 2014
Last Updated
December 6, 2015
Sponsor
Universidade Federal de Sao Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02217423
Brief Title
Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy
Acronym
RACCRPPT
Official Title
The Relationship Between Abdominal Circumference and Cardiorespiratory Repercussions in Hospitalized Patients Submitted to Physical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Lung Disease
Keywords
Physical Therapy Modalities, Respiration Disorders, Respiratory Therapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obstructive increased AC
Arm Type
Experimental
Arm Description
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.
Arm Title
Obstructive disfunction with normal AC
Arm Type
Experimental
Arm Description
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.
Arm Title
Restrictive increased AC
Arm Type
Experimental
Arm Description
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.
Arm Title
Restrictive disfunction with normal AC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy chest wall expansion
Other Intervention Name(s)
Chest physiotherapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy airway clearance modality
Other Intervention Name(s)
Chest physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in spirometric measures.
Description
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.
Time Frame
Baseline, five and thirty minutes.
Secondary Outcome Measure Information:
Title
Comparison of pulse oxymetry before/after chest physiotherapy. Comparison of blood pressure before/after chest physiotherapy.
Description
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.
Time Frame
Baseline, five and thirty minutes.
Other Pre-specified Outcome Measures:
Title
Comparison of heart rate variability before/after chest physiotherapy. Comparison of thoracoabdominal perimetry before/after chest physiotherapy.
Description
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.
Time Frame
Baseline, five and thirty minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Martinelli, Me
Organizational Affiliation
UFSCar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Estadual Manoel de Abreu
City
Bauru
State/Province
SP
ZIP/Postal Code
17051-000
Country
Brazil
12. IPD Sharing Statement
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Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy
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