Pulmonary InfectionPENCT04553315
the Effect of Chest Expansion Exercises on Pleural Effusion
A study testing chest expansion exercises in people with Pulmonary Infection and Complication, run by Sarah Asmaa at 1 site in Egypt.
Trial summary
the study attempted to assess and evaluate the efficacy of implementing chest expansion exercises on patients with pleural effusion and how this programme contribute to reduce pulmonary infection and complications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Infection, Complication
- What is being tested?
- chest expansion exercises
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 30 Jul 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 - 60 years.
- patients of both genders.
- patients diagnosed as pleural effusion by the physician.
- patients with asymmetrical chest expansion.
Who cannot join
- Orthopedic conditions.
- Pleural effusion due to transudate conditions like: liver cirrhosis, …. etc.
- Malignant conditions.
- Cognitive impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chest Expansion Exercises on Reducing Pulmonary Infection and Complications in Patients With Pleural Effusion
the study attempted to assess and evaluate the efficacy of implementing chest expansion exercises on patients with pleural effusion and how this programme contribute to reduce pulmonary infection and complications.
To address the objective of the study, the researcher utilized chest expansion exercises consisted of stacked breathing exercise, segmental breathing, chest mobility exercises, deep breathing exercise with use of incentve spirometer and assess the patient before and after exercises by using three tools help to monitor hemodynamic parameters, chest condition, laboratory investigations which help to evaluate pulmonary infection score and complications.
Read the detailed description
Introduction Plural effusion is a syndrome occurs frequently in hospitalized patients, leading to increased morbidity, mortality, and healthcare expenditure. A plural effusion represents the disturbance of the normal mechanisms of formation and drainage of fluid from the plural space .
Plural effusion is defined as a fluid collection between the plural leaves due to local/systemic disease of the pleura, lung or extra-pulmonary organs. Normally, 0.1 to 0.2 ml/kg of fluid is present in the plural leaves to facilitate plural movement. When the balance between the production and re-absorption of this fluid deteriorates, it becomes plural effusion .
The accumulation of plural effusion has important effects on respiratory system function. It changes the elastic equilibrium volumes of the lung and chest wall, resulting in a restrictive ventilatory effect, chest wall expansion and reduced efficiency of the inspiratory muscles. The magnitude of these alterations depends on the plural fluid volume and the underlying disease of the respiratory system. The decrease in lung volume is associated with hypoxemia mainly due to an increase in right to left shunt. The drainage of pleural fluid results in an increase in lung volume that is considerably less than the amount of aspirated fluid, while hypoxemia is not readily reversible upon fluid aspiration .
Pleural effusions are traditionally classified as either transudates or exudates. Diseases that affect the filtration of pleural fluid result in transudate formation and often occur bilaterally. Inflammation or injury increases pleural capillary membrane permeability to proteins and various types of cells and lead to the formation of an exudative effusion .
This study was designed as a randomised controlled trial to determine the effect of chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion.
Methods Design Structured as a randomized-controlled prospective study, the objective of this study was to determine the efficacy of the chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion.
Setting Data was collected from chest ICU and critical ICU in Assiut university hospital .
Sample The study population consisted of patients eighteen to sixty years old, hospitalized and treated in Critical, Chest intensive care units. The inclusion criteria stipulated that the patient was between eighteen and sixty years old; both genders were included; diagnosed as plural effusion by the physician; and with a symmetrical chest expansion and agreed to participate in the study. A power calculation estimated that in order to detect an effect size of 0.29 difference in mean of pulmonary function between the two studied groups, with a p-value < 0.05 and 80 % power, confidence level 0.95, a sample size of 20 patients for each group was needed. However, 60 patients were attempted in this research work to avoid non-response rate (30 for each group). This calculated using G Power 3.1 . The study data was collected between June 2019 and June 2020.
Instruments and measurements Three tools used in this study were developed by the researcher based on reviewing of the relevant literature.
The first tool was Plural effusion assessment sheet used to monitor hemodynamic parameters included (Mean arterial pressure (MAP) taken from bed side monitor, heart rate (HR), temperature, respiratory rate and CVP readings, assessment of respiratory system consisted of : Chest examination done every shift before and after exercise, chest x-ray assessment, Sputum and blood culture assessment, Ventilator profile assessment , assessment of plural procedures done, assessment of clinical pulmonary infection score, fluid balance assessment., assessment of laboratory findings in addition to socio-demographic and medical data.
The second tool is Chest expansion exercises sheet : was developed by the researcher and used to assess exercises done to the patient and included: Chest mobility exercise; Stacked breathing exercise; Segmental breathing exercise; Deep breathing exercise and Incentive spirometer exercise.
The third tool is Patients' outcomes evaluation sheet which was developed by the researcher and used to assess the effect of chest expansion exercises on pulmonary infection score and complications.
Intervention After getting ethical clearance patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization.
Intervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique . The patient in the intervention group was instructed to perform the exercises 3 times per day, 7-8 times per session for one week. Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of (30-35 ml/kg/day) with restriction of intravenous fluids.
Data collection The data were collected from the first day of admission after stabilization of the patient's condition and extended to 7 days, every day and every shift then the data were recorded in the developed tools.The researcher assigned study sample (30 patients) to two groups (Control group, Intervention group).
For the control group: The researcher assessed patients who were receiving the routine hospital care. For Intervention group: The researcher assessed patients then applying chest expansion exercises.
Ethical considerations There was no risk for study subject during application of the study as the study followed common ethical principles in clinical research and has been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) and written consent was obtained from patients or guidance that participated in the study after explaining the nature and purpose of the study.
Patient was assured that the data of this research was not be reused without second permission, confidentiality and anonymity was assured and the patients had the right to refuse to participate or withdraw from the study without any rational at any time.
Data analysis Data were computerized and analyzed by computer programmed SPSS (ver.16). Data were presented by using descriptive statistics in the form of frequencies and percentages or means ± standard deviations for qualitative data. Quantitative data were compared using Independent samples t-test for comparisons among two groups. Qualitative variables were compared using chi-square test to determine significance. The critical value of the tests "P" was considered statistically significant when P less than 0.05.
- Conditions
- Pulmonary Infection, Complication
- Being tested
- chest expansion exercises
- Keywords
- Chest expansion exercises, complications, pleural effusion, pulmonary infection
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest expansion exercisesProcedure or surgery
Chest mobility exercises with Incentive spirometer and segmental breathing exercise ) and breath stacking technique e.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Intervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique . The patient in the intervention group was instructed to perform the exercises 3 times per day, 7-8 times per session for one week. Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of (30-35ml/kg/day) with restriction of intravenous fluids. Receives: Procedure: chest expansion exercises |
| control group | Experimental | control group will receive only routine hospital care Receives: Procedure: chest expansion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of pulmonary infection
through the study pulmonary infection will be assessed by using pulmonary infection score by assessing parameters as WBCs, temperature and chest condition
Measured: 1 year
rate of complications
complications will be assessed through the study by using evaluation outcomes tool
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- implementing chest expansion exercises on patient with pleural effusion to evaluate its efficacy on preventing pulmonary infection and complications
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Asmaa
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Sarah Asmaa, Assiut University
- Investigators
- Amal A Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553315
- Sponsor's protocol ID
- Chest expansion exercises
- Other IDs
- sasmaa
- Acronym
- PE
- Status last verified
- Sep 2020
- First submitted
- 30 Aug 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chest Expansion Exercises on Reducing Pulmonary Infection and Complications in Patients With Pleural Effusion
- ClinicalTrials.gov ID
- NCT04553315
- Acronym / sponsor ID
- PE / Chest expansion exercises
- Conditions
- Pulmonary Infection, Complication
- Keywords
- Chest expansion exercises, complications, pleural effusion, pulmonary infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sarah AsmaaUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 17 Sep 2020 (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 attempted to assess and evaluate the efficacy of implementing chest expansion exercises on patients with pleural effusion and how this programme contribute to reduce pulmonary infection and complications.
To address the objective of the study, the researcher utilized chest expansion exercises consisted of stacked breathing exercise, segmental breathing, chest mobility exercises, deep breathing exercise with use of incentve spirometer and assess the patient before and after exercises by using three tools help to monitor hemodynamic parameters, chest condition, laboratory investigations which help to evaluate pulmonary infection score and complications.
Detailed description
Introduction Plural effusion is a syndrome occurs frequently in hospitalized patients, leading to increased morbidity, mortality, and healthcare expenditure. A plural effusion represents the disturbance of the normal mechanisms of formation and drainage of fluid from the plural space .
Plural effusion is defined as a fluid collection between the plural leaves due to local/systemic disease of the pleura, lung or extra-pulmonary organs. Normally, 0.1 to 0.2 ml/kg of fluid is present in the plural leaves to facilitate plural movement. When the balance between the production and re-absorption of this fluid deteriorates, it becomes plural effusion .
The accumulation of plural effusion has important effects on respiratory system function. It changes the elastic equilibrium volumes of the lung and chest wall, resulting in a restrictive ventilatory effect, chest wall expansion and reduced efficiency of the inspiratory muscles. The magnitude of these alterations depends on the plural fluid volume and the underlying disease of the respiratory system. The decrease in lung volume is associated with hypoxemia mainly due to an increase in right to left shunt. The drainage of pleural fluid results in an increase in lung volume that is considerably less than the amount of aspirated fluid, while hypoxemia is not readily reversible upon fluid aspiration .
Pleural effusions are traditionally classified as either transudates or exudates. Diseases that affect the filtration of pleural fluid result in transudate formation and often occur bilaterally. Inflammation or injury increases pleural capillary membrane permeability to proteins and various types of cells and lead to the formation of an exudative effusion .
This study was designed as a randomised controlled trial to determine the effect of chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion.
Methods Design Structured as a randomized-controlled prospective study, the objective of this study was to determine the efficacy of the chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion.
Setting Data was collected from chest ICU and critical ICU in Assiut university hospital .
Sample The study population consisted of patients eighteen to sixty years old, hospitalized and treated in Critical, Chest intensive care units. The inclusion criteria stipulated that the patient was between eighteen and sixty years old; both genders were included; diagnosed as plural effusion by the physician; and with a symmetrical chest expansion and agreed to participate in the study. A power calculation estimated that in order to detect an effect size of 0.29 difference in mean of pulmonary function between the two studied groups, with a p-value < 0.05 and 80 % power, confidence level 0.95, a sample size of 20 patients for each group was needed. However, 60 patients were attempted in this research work to avoid non-response rate (30 for each group). This calculated using G Power 3.1 . The study data was collected between June 2019 and June 2020.
Instruments and measurements Three tools used in this study were developed by the researcher based on reviewing of the relevant literature.
The first tool was Plural effusion assessment sheet used to monitor hemodynamic parameters included (Mean arterial pressure (MAP) taken from bed side monitor, heart rate (HR), temperature, respiratory rate and CVP readings, assessment of respiratory system consisted of : Chest examination done every shift before and after exercise, chest x-ray assessment, Sputum and blood culture assessment, Ventilator profile assessment , assessment of plural procedures done, assessment of clinical pulmonary infection score, fluid balance assessment., assessment of laboratory findings in addition to socio-demographic and medical data.
The second tool is Chest expansion exercises sheet : was developed by the researcher and used to assess exercises done to the patient and included: Chest mobility exercise; Stacked breathing exercise; Segmental breathing exercise; Deep breathing exercise and Incentive spirometer exercise.
The third tool is Patients' outcomes evaluation sheet which was developed by the researcher and used to assess the effect of chest expansion exercises on pulmonary infection score and complications.
Intervention After getting ethical clearance patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization.
Intervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique . The patient in the intervention group was instructed to perform the exercises 3 times per day, 7-8 times per session for one week. Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of (30-35 ml/kg/day) with restriction of intravenous fluids.
Data collection The data were collected from the first day of admission after stabilization of the patient's condition and extended to 7 days, every day and every shift then the data were recorded in the developed tools.The researcher assigned study sample (30 patients) to two groups (Control group, Intervention group).
For the control group: The researcher assessed patients who were receiving the routine hospital care. For Intervention group: The researcher assessed patients then applying chest expansion exercises.
Ethical considerations There was no risk for study subject during application of the study as the study followed common ethical principles in clinical research and has been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) and written consent was obtained from patients or guidance that participated in the study after explaining the nature and purpose of the study.
Patient was assured that the data of this research was not be reused without second permission, confidentiality and anonymity was assured and the patients had the right to refuse to participate or withdraw from the study without any rational at any time.
Data analysis Data were computerized and analyzed by computer programmed SPSS (ver.16). Data were presented by using descriptive statistics in the form of frequencies and percentages or means ± standard deviations for qualitative data. Quantitative data were compared using Independent samples t-test for comparisons among two groups. Qualitative variables were compared using chi-square test to determine significance. The critical value of the tests "P" was considered statistically significant when P less than 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- implementing chest expansion exercises on patient with pleural effusion to evaluate its efficacy on preventing pulmonary infection and complications
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: chest expansion exercisesIntervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique . The patient in the intervention group was instructed to perform the exercises 3 times per day, 7-8 times per session for one week. Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of (30-35ml/kg/day) with restriction of intravenous fluids. |
| control group | Experimental | Procedure: chest expansion exercisescontrol group will receive only routine hospital care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age of 18 - 60 years.
- patients of both genders.
- patients diagnosed as pleural effusion by the physician.
- patients with asymmetrical chest expansion.
Key exclusion criteria (4 listed)
- Orthopedic conditions.
- Pleural effusion due to transudate conditions like: liver cirrhosis, …. etc.
- Malignant conditions.
- Cognitive impairments.
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 |
|---|---|---|
| chest expansion exercisesChest mobility exercises with Incentive spirometer and segmental breathing exercise ) and breath stacking technique e. | Procedure or surgery | control group, intervention group |
Primary outcome
score of pulmonary infection
Time frame: 1 year
through the study pulmonary infection will be assessed by using pulmonary infection score by assessing parameters as WBCs, temperature and chest condition
rate of complications
Time frame: 1 year
complications will be assessed through the study by using evaluation outcomes tool
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 5 Oct 2020.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
Amal A Mohamed principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest expansion exercises in people with Pulmonary Infection and Complication, run by Sarah Asmaa 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 4 inclusion and 4 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 5 Oct 2020. 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?
score of pulmonary infection (time frame: 1 year). 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 5 Oct 2020.