Chronic Obstructive Pulmonary DiseaseNCT05448235
the Effectivness of the Thoracic Cage Mobilization on COPD Patients
A study testing conventional treatment and thoracic mobilization in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
Trial summary
the study aims to investigate effectiveness of thoracic cage mobilizations on the chronic obstructive pulmonary diseases. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- conventional treatment and thoracic mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effectiveness of the Thoracic Cage Mobilization on Chronic Obstructive Pulmonary Disease Patients
the study aims to investigate effectiveness of thoracic cage mobilizations on the chronic obstructive pulmonary diseases.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- conventional treatment, thoracic mobilization
- Keywords
- Thoracic cage mobilization, conventional treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional treatmentOther
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.
thoracic mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Experimental | the patient will receive conventional treatment daily for up to one week Receives: Other: conventional treatment |
| thoracic cage mobilization | Experimental | the patient will receive thoracic cage mobilization added to conventional treatment daily for up to one week Receives: Other: conventional treatment; Other: thoracic mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up for one week
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
Measured: up for one week
Secondary outcomes (2)
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)
Measured: up for one week
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
Measured: up for one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start21 Oct 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between two groups one receive conventional treatment and other receives conventional treatment and thoracic mobilization
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam omran Grase, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448235
- Sponsor's protocol ID
- P. T. REC/012/003514
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness of the Thoracic Cage Mobilization on Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT05448235
- Acronym / sponsor ID
- P. T. REC/012/003514
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Thoracic cage mobilization, conventional treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison between two groups one receive conventional treatment and other receives conventional treatment and thoracic mobilization
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Experimental | Other: conventional treatmentthe patient will receive conventional treatment daily for up to one week |
| thoracic cage mobilization | Experimental | Other: conventional treatment, Other: thoracic mobilizationthe patient will receive thoracic cage mobilization added to conventional treatment daily for up to one week |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional treatmentthe 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. | Other | conventional treatment, thoracic cage mobilization |
| thoracic mobilizationwe 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. | Other | thoracic cage mobilization |
Primary outcome
ABG
Time frame: up for one week
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
Time frame: up for one week
using tape to measure chest exp ansion during inspiration and expiration at axillary level and at the level of T10 using CM units
2 secondary outcomes
CAT questionnaire
Time frame: up for one week
Dyspnea index
Time frame: up for one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional treatment and thoracic mobilization in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABG (time frame: up for one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.