- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02217423
Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy (RACCRPPT)
The Relationship Between Abdominal Circumference and Cardiorespiratory Repercussions in Hospitalized Patients Submitted to Physical Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
Bauru, SP, Brazil, 17051-000
- Hospital Estadual Manoel de Abreu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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:
|
|
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:
|
|
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:
|
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
Investigators
- Principal Investigator: Bruno Martinelli, Me, Ufscar
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34609514100005502
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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