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the Effectivness of the Thoracic Cage Mobilization on COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional treatment
thoracic mobilization
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Thoracic cage mobilization, conventional treatment

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of chronic obstructive pulmonary disease.
  • Age >35 years.
  • Received conventional medical treatment.
  • the presence of at least two of the following three clinical criteria: a recent increase in breathlessness, sputum volume or sputum purulence.
  • All enrolled patients either had previously been given a diagnosis of COPD by a physician or had at least a one-year history of chronic breathlessness or cough with sputum production

Exclusion Criteria:

  • Admitted to the hospital, had been given a diagnosis of asthma or atrophy.
  • Patients who had received oral or intravenous corticosteroid in the emergency department within the preceding 30 days.
  • patient put on the mechanical ventilation.

Sites / Locations

  • Mariam omran Grase

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conventional treatment

thoracic cage mobilization

Arm Description

the patient will receive conventional treatment daily for up to one week

the patient will receive thoracic cage mobilization added to conventional treatment daily for up to one week

Outcomes

Primary Outcome Measures

ABG
to measure pH (7.35-7.45), PaO2 (75-100 mmHg), PaCO2 (35-45 mmHg), HCO3 (22-26 meq/L) and SaO2 (95-100%) we will measure these types of ABG Before and after the treatment and measure the difference before and after and compared it with the standard to detect the effect of the treatment on the lung function
chest expansion with tape measurement
using tape to measure chest exp ansion during inspiration and expiration at axillary level and at the level of T10 using CM units

Secondary Outcome Measures

CAT questionnaire
to measure the patients status during treatment and after and It has eight categories (cough severity, presence of mucus, chest tightness, dyspnea, limits during domestic activities, social constraints, sleep, and energy restriction) with scores ranging from 0 (no impact) to 40 (significant impact) (severe impact) On a 7-point Likert scale (ranging from 1 to 7)
Dyspnea index
to measure the breathlessness after the treatment,used to determine levels of exertion and the Levels of shortness of breath (SOB): No SOB: can count to 15 (takes about 8 seconds) without taking a breath in the sequence. Mild SOB: can count to 15 but must take one short breath in the sequence. Moderate SOB; need to take 2 breaths to count to 15 in the sequence. Definite SOB: must take 3 breaths in the sequence of counting to 15. Severe SOB: unable to count

Full Information

First Posted
June 22, 2022
Last Updated
February 15, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05448235
Brief Title
the Effectivness of the Thoracic Cage Mobilization on COPD Patients
Official Title
the Effectiveness of the Thoracic Cage Mobilization on Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
the study aims to investigate effectiveness of thoracic cage mobilizations on the chronic obstructive pulmonary diseases.
Detailed Description
COPD is a term for airflow restriction and growing shortness of breath caused by physiological deterioration. Elderly persons endure reduced respiratory function, stiffness in the joints and connective tissues of the rib cage, and increased thoracic Kyphosis as a result of COPD .breathlessness, cough, and sputum production are the most prevalent symptoms of COPD, while wheezing, chest tightness, and chest congestion are less common but nevertheless bothersome. The reported frequency, on the other hand, varies depending on the patient demographic and the severity of the disease. COPD is now the world's fourth greatest cause of mortality, but it is expected to rise to the third position by 2020. Due to the obstruction and exhalation airflow is reduced, resulting in air trapping and hyperinflation. When the rate of minute ventilation or respiration is increased, for as during exercise, this becomes more apparent. Hyperinflation puts more strain on the respiratory muscles, forcing them to function in a restricted range of motion with a negative pressure/effort ratio, resulting in fatigue and increased shortness of breath. COPD patients avoid physical activity and adopt a more sedentary lifestyle than healthy older adults in order to prevent the distressing feeling of breathlessness. This, in turn, causes a vicious cycle of decreased exercise capacity, increased breathlessness during exercise, and more avoidance of exercise, and so on. Active expiration, slow and deep breathing, pursed lips breathing, relaxation therapy, body positions such as forward leaning, inspiratory and expiratory muscle training, and diaphragmatic breathing are all examples of breathing techniques. Improvement of (regional) ventilation and gas exchange, decrease of dynamic hyperinflation, enhancement of respiratory muscle function, reduction of breathlessness, and improvement of exercise tolerance and quality of life are some of the goals of these procedures. Exercise capacity is impaired in COPD, both peak exercise capacity and functional exercise capacity. Besides lung hyperinflation and physical inactivity, ventilation-perfusion mismatch, hypoxemia, cardiovascular problems and muscular changes Reduced exercise capacity is a factor. One of the most important predictors of morbidity and mortality in COPD is functional exercise ability. and has a direct connection to everyday physical activities. Because rib cage mobility tends to be diminished with obstructive lung illness, PT appears to have a specific goal of rib cage joint mobility. Chest wall mobilization enhances chest wall mobility, lowers respiratory rate, raises tidal volume, improves ventilation gas exchange, reduces breathlessness, reduces work of breathing, and helps you relax. The rib cage mobilization is applied in three positions, supine ling, side lying and siding with arm abducted of the side to be mobilized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Thoracic cage mobilization, conventional treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparison between two groups one receive conventional treatment and other receives conventional treatment and thoracic mobilization
Masking
ParticipantOutcomes Assessor
Masking Description
the patients , care provider and investigator do not know the groups receive treatment
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional treatment
Arm Type
Experimental
Arm Description
the patient will receive conventional treatment daily for up to one week
Arm Title
thoracic cage mobilization
Arm Type
Experimental
Arm Description
the patient will receive thoracic cage mobilization added to conventional treatment daily for up to one week
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
the patient will be asked to make pursed lip breathing (Breathe in for 2 seconds through his nose and Breathe out for 4 seconds through pursed lips)for 5-10 min ,3-4 times , 8-10 rep each cycle then asked to make diaphragmatic breathing exercise (Lie on his/her back and Inhale deeply through his/her nose for a count of three)for 5-10 min , 3-4 times , 8-10 repetition then postural drainage , furthermore the patient takes different position (prone to make percussion on lower lobes, side lying on anterior basal segment then sitting position on the upper lobe). After that a vibration on the chest (place a flat hand firmly atop the lung segment to be drained., and should apply light pressure and create a rapid, shaking movement) 1 min inhale and 5 time of repetition at the exhale and finally asked the patient to make productive cough for 5 times to get out the sputum.
Intervention Type
Other
Intervention Name(s)
thoracic mobilization
Intervention Description
we will use A SNAG to mobilization using type 3 oscillatory and sustain for 90 second, at first put the patient in 3 position (side lying to make mobilization of upper 6 ribs in downward direction then make on lower 6 ribs ,furthermore flexion of the thoracic and next rotation toward the midline then ask the patient to transfer to supine lying position and mobilize the sternum in downward direction the next mobilize the clavicle and ask the patient to take sitting position and put his hand on his head in adduction position and make extension on the thoracic vertebrae with inward mobilize with the investigator knees ,take each 4 vertebrae along the 12 thoracic vertebrae.
Primary Outcome Measure Information:
Title
ABG
Description
to measure pH (7.35-7.45), PaO2 (75-100 mmHg), PaCO2 (35-45 mmHg), HCO3 (22-26 meq/L) and SaO2 (95-100%) we will measure these types of ABG Before and after the treatment and measure the difference before and after and compared it with the standard to detect the effect of the treatment on the lung function
Time Frame
up for one week
Title
chest expansion with tape measurement
Description
using tape to measure chest exp ansion during inspiration and expiration at axillary level and at the level of T10 using CM units
Time Frame
up for one week
Secondary Outcome Measure Information:
Title
CAT questionnaire
Description
to measure the patients status during treatment and after and It has eight categories (cough severity, presence of mucus, chest tightness, dyspnea, limits during domestic activities, social constraints, sleep, and energy restriction) with scores ranging from 0 (no impact) to 40 (significant impact) (severe impact) On a 7-point Likert scale (ranging from 1 to 7)
Time Frame
up for one week
Title
Dyspnea index
Description
to measure the breathlessness after the treatment,used to determine levels of exertion and the Levels of shortness of breath (SOB): No SOB: can count to 15 (takes about 8 seconds) without taking a breath in the sequence. Mild SOB: can count to 15 but must take one short breath in the sequence. Moderate SOB; need to take 2 breaths to count to 15 in the sequence. Definite SOB: must take 3 breaths in the sequence of counting to 15. Severe SOB: unable to count
Time Frame
up for one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of chronic obstructive pulmonary disease. Age >35 years. Received conventional medical treatment. the presence of at least two of the following three clinical criteria: a recent increase in breathlessness, sputum volume or sputum purulence. All enrolled patients either had previously been given a diagnosis of COPD by a physician or had at least a one-year history of chronic breathlessness or cough with sputum production Exclusion Criteria: Admitted to the hospital, had been given a diagnosis of asthma or atrophy. Patients who had received oral or intravenous corticosteroid in the emergency department within the preceding 30 days. patient put on the mechanical ventilation.
Facility Information:
Facility Name
Mariam omran Grase
City
Giza
ZIP/Postal Code
12511
Country
Egypt

12. IPD Sharing Statement

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