Inhalation InjuryNCT05988294
Pilates Exercises in Patients with Inhalation Injury
A study testing Pilates exercises and Conventional physical therapy exercise program in people with Inhalation Injury, run by Cairo University at 1 site in Egypt.
Trial summary
Inhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Inhalation Injury
- What is being tested?
- Pilates exercises and Conventional physical therapy exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2023to 30 May 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients in both sexes and their age will range from 20-50 years.
- Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
- Patients suffering from retained secretions which did not respond to medical treatment. (4) All patients should be clinically and medically stable.
- All patients should have the same medical treatment.
Who cannot join
- Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months.
- Participants with less than an 85% attendance rate at the sessions.
- Participants with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, uncontrolled hypertension, malignancy, cardiovascular diseases, deep vein thrombosis, rheumatoid arthritis, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, or hearing impairments and contractures.
- Smokers.
- Pregnant females.
- Obese participants (BMI > 30 kg/m2).
- Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients with Inhalation Injury After Thermal Burn.
Inhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.
Read the detailed description
Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be handled in their early stages. In the case of fibrinous material transudates, compromised mucociliary secretions and mucosal slough must be cleared. There are different methods to assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and chest physiotherapy.
In Pilates method (PM), several muscles are activated, including the muscles involved in breathing, especially to improve the expiratory function, which remains contracted during the inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM exercises, where the practitioner learns how to breathe properly as an essential part of each exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing aids in controlling movements, and therefore, the method can be regarded as an indirect strategy for respiratory muscle training. It is known that poor control of breathing can result in compensation and lung volumes and respiratory muscle performance, with several factors involved.
- Conditions
- Inhalation Injury
- Being tested
- Pilates exercises, Conventional physical therapy exercise program
- Keywords
- Pilates exercises, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity Response, Inhalation Injury, Thermal Burn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
One-hour Pilates exercise program was given by a certified trainer to patients three times per week for 12 weeks. The exercise program followed the basic principles of the Pilates method. Our protocol comprised the following components of Pilates-based exercises: strength and stabilization, flexibility and range of motion, proper body alignment, balance, coordination, and body awareness. Resistance bands and 26 cm Pilates balls were used as supportive equipment. The exercise sections consisted of 5 minutes breathing, 10 minutes warm-up, 35 minutes conditioning phase and 10 minutes cool-down.
Conventional physical therapy exercise programOther
Diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs for 45 minutes, 3 days/ week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Pilates Group) | Experimental | Participants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks. Receives: Other: Pilates exercises; Other: Conventional physical therapy exercise program |
| Group B (Control Group) | Other | Participants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks. Receives: Other: Conventional physical therapy exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
Forced vital capacity (FVC) will be measured by using spirometer
Measured: 12 weeks
forced expiratory volume in 1 second (FEV1)
forced expiratory volume in 1 second (FEV1) will be measured by using spirometer
Measured: 12 weeks
peak expiratory flow (PEF)
peak expiratory flow (PEF) will be measured by using spirometer
Measured: 12 weeks
Secondary outcomes (2)
Respiratory muscle strength
The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer
Measured: 12 weeks
Functional capacity
By using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Jul 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation InjuryStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Doaa A Elimy, PhD, Study director, Lecturer of basic science, Faculty of Physical Therapy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988294
- Sponsor's protocol ID
- P.T.REC/012/004571
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients with Inhalation Injury After Thermal Burn.
- ClinicalTrials.gov ID
- NCT05988294
- Acronym / sponsor ID
- P.T.REC/012/004571
- Conditions
- Inhalation Injury
- Keywords
- Pilates exercises, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity Response, Inhalation Injury, Thermal Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Inhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.
Detailed description
Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be handled in their early stages. In the case of fibrinous material transudates, compromised mucociliary secretions and mucosal slough must be cleared. There are different methods to assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and chest physiotherapy.
In Pilates method (PM), several muscles are activated, including the muscles involved in breathing, especially to improve the expiratory function, which remains contracted during the inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM exercises, where the practitioner learns how to breathe properly as an essential part of each exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing aids in controlling movements, and therefore, the method can be regarded as an indirect strategy for respiratory muscle training. It is known that poor control of breathing can result in compensation and lung volumes and respiratory muscle performance, with several factors involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Pilates Group) | Experimental | Other: Pilates exercises, Other: Conventional physical therapy exercise programParticipants will receive Pilates exercises for 60 minutes followed by conventional physical therapy program for 45 minutes, 3 days/ week for 12 weeks. |
| Group B (Control Group) | Other | Other: Conventional physical therapy exercise programParticipants will receive conventional physical therapy program (diaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs) for 45 minutes, 3 days/ week for 12 weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients in both sexes and their age will range from 20-50 years.
- Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
- Patients suffering from retained secretions which did not respond to medical treatment. (4) All patients should be clinically and medically stable.
- All patients should have the same medical treatment.
Key exclusion criteria (7 listed)
- Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months.
- Participants with less than an 85% attendance rate at the sessions.
- Participants with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, uncontrolled hypertension, malignancy, cardiovascular diseases, deep vein thrombosis, rheumatoid arthritis, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, or hearing impairments and contractures.
- Smokers.
- Pregnant females.
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 |
|---|---|---|
| Pilates exercisesOne-hour Pilates exercise program was given by a certified trainer to patients three times per week for 12 weeks. The exercise program followed the basic principles of the Pilates method. Our protocol comprised the following components of Pilates-based exercises: strength and stabilization, flexibility and range of motion, proper body alignment, balance, coordination, and body awareness. Resistance bands and 26 cm Pilates balls were used as supportive equipment. The exercise sections consisted of 5 minutes breathing, 10 minutes warm-up, 35 minutes conditioning phase and 10 minutes cool-down. | Other | Group A (Pilates Group) |
| Conventional physical therapy exercise programDiaphragmatic deep breathing exercises, bronchial hygiene techniques, assisted cough, stretching exercises and ROM exercises for both upper and lower limbs for 45 minutes, 3 days/ week for 12 weeks. | Other | Group A (Pilates Group), Group B (Control Group) |
Primary outcome
Forced vital capacity (FVC)
Time frame: 12 weeks
Forced vital capacity (FVC) will be measured by using spirometer
forced expiratory volume in 1 second (FEV1)
Time frame: 12 weeks
forced expiratory volume in 1 second (FEV1) will be measured by using spirometer
peak expiratory flow (PEF)
Time frame: 12 weeks
peak expiratory flow (PEF) will be measured by using spirometer
2 secondary outcomes
Respiratory muscle strength
Time frame: 12 weeks
Functional capacity
Time frame: 12 weeks
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 20 Sep 2024.
- Individual participant dataSharing planned: Yes. Study results
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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.
Doaa A Elimy, PhD study director
Lecturer of basic science, Faculty of Physical Therapy Cairo 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 Pilates exercises and Conventional physical therapy exercise program in people with Inhalation Injury, 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 4 inclusion and 7 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 20 Sep 2024. 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?
Forced vital capacity (FVC) (time frame: 12 weeks). The study lists 3 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 20 Sep 2024.