Covid19NCT04919031
Inspiratory Muscle Trainer and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Persistent Symptoms
A study testing Inspiratory muscle trainer and diaphragmatic release in people with Covid19 and Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
Inspiratory muscle training considered as safe and valid method to improve respiratory muscle strength and functional capacity among uncountable conditions which could improve post COVID-19 persistent symptoms including but not limited to respiratory muscle strength, diminishing dyspnea, enhance blood oxygenation, and… Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Covid19, Hypertension, Corona Persistent Symptoms
- What is being tested?
- Inspiratory muscle trainer and diaphragmatic release
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 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 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- sixty non hospitalized negative post covid-19
- men
- cigarette smokers
- 40-60 years old
- stage II Hypertensive (160-179 / 100-109 mmHg)
- Oxygen saturation less than 94%
Show all 10Show fewer
- Severity of disease (Moderate Covid-19 affection)
- Body mass index (BMI) ranged from 25 to 29.9 kg/m2
- hemodynamically stable
- at least 4 weeks since first COVID-19 swab at time of screening
Who cannot join
- Patients with red flag indicators as chest pain, critical drop of oxygen saturation which require oxygen supply, severe level of hypoxia (blue lips)
- Unconscious patient
- Positive covid-19 patients
- Patients with cognitive impairment
- End-stage of chronic diseases
- BMI more than 30 kg/m2
Show all 11Show fewer
- History of other cardiovascular disease as coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease
- Neurological, neuromuscular, and musculoskeletal limitations
- Current active infection
- Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
- Participation in a clinical study or other type of research in the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Muscle Trainer Impact on Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Hypertensive Patients With Long Term Persistent Symptoms
Inspiratory muscle training considered as safe and valid method to improve respiratory muscle strength and functional capacity among uncountable conditions which could improve post COVID-19 persistent symptoms including but not limited to respiratory muscle strength, diminishing dyspnea, enhance blood oxygenation, and patient's functional capacity and quality of life.
Read the detailed description
The current COVID-19 pandemic will place enormous pressure on healthcare systems around the world. The COVID-19 pandemic continues to dominate our daily lives with large numbers of people are predicted to become critically ill with acute respiratory distress syndrome and will require management in intensive care units. Unfortunately, it is expected that COVID-19 will persist as a major challenge for the delivery of medical care for a long while to go. High levels of physical, cognitive, and psychosocial impairments can be anticipated and persist after discharging from hospitals. Growing data shows a higher risk of COVID-19 infections and complications in people with high blood pressure affecting between 30% to 50% of the patients.
Intensive care unit- acquired weakness is very common after ARDS (COVID 19) which confers a major determinant of poor long-term functional, respiratory and psychological outcome.
Patients with coronavirus disease (COVID-19) are described as exhibiting oxygen levels incompatible with life with dyspnea. Pulse oximeter is valid device used to assess oxygen level in the blood as well as the pulse rate. As case numbers grow, neurological symptoms have been reported with increasing the frequency of corona virus infection, including those of autonomic dysfunction. It was reported that many patients developed postural tachycardia syndrome (POTS) several months after confirmed SARSCoV- 2 infection especially those with cardiovascular risk factors. Based on knowledge from the multiple systemic complications associated with Covid-19, it is reasonable to suggest that most patients, especially those who underwent prolonged hospitalization with one or more cardiovascular risk factor, will need a multi professional rehabilitation program.
Respiratory rehabilitation aims to improve quality of life by managing dyspnea, improving exercise tolerance and increasing functional capacity. After initial recovery from Covid-19, especially for those who required hospitalization in ICU, it is possible that some patients may experience respiratory muscle dysfunction, as well as pulmonary restriction or obstruction to varying extents, affecting peripheral muscle function and respiratory conditioning.
Several previous studies explained that inspiratory muscle training (IMT) is a feasible and safe modality in patients with respiratory muscle dysfunction which approve its efficacy in enhancing respiratory muscle strength, improving aerobic capacity, and diminishing dyspnea among patients suffering from COVID 19.
- Conditions
- Covid19, Hypertension, Corona Persistent Symptoms
- Being tested
- Inspiratory muscle trainer, diaphragmatic release
- Medical subject headings
- COVID-19, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainerDevice
POWER breathe IMT is a drug-free, hand-held breathing training device. The medical term for this type of breathing training is Inspiratory Muscle Training, or IMT. POWER breathe IMT exercises the main muscles you use to breathe in, primarily your diaphragm and intercostal
diaphragmatic releaseOther
diaphragmatic release is a manual technique use for restoring the ability of the diaphragm to go through a full range of motion
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | Inspiratory muscle trainer plus diaphragmatic release and traditional medications Receives: Device: Inspiratory muscle trainer; Other: diaphragmatic release |
| control | Active comparator | inspiratory muscle trainer plus traditional medications Receives: Device: Inspiratory muscle trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal inspiratory pressure
For determining MIP, patients breathe through a flanged mouthpiece with nose clips in place. They are instructed to exhale to RV. At RV, a valve or shutter is closed, and the patient is coached to inhale as forcefully as possible. Maximum pull should be maintained for 1-2 seconds.
Measured: 6 weeks
Secondary outcomes (11)
sleeping quality scale
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating and maintaining sleep, difficulty waking, and sleep satisfaction. Using a four-point, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always").
Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) and are reversed before being tallied. Total scores can range from 0 to 84, with higher scores demoting more acute sleep problems.
Measured: 6 weeks
Timed stair climbing
Total time to ascend and descend steps is recorded to the nearest 100th of a second. Lower values = better performance
Measured: 6 weeks
6 minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes by meter is used as the outcome by which to compare changes in performance capacity.
Measured: 6 weeks
modified medical research council (mMRC) scale (0-4)
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
Measured: 6 weeks
Oxygen saturation
pulse ox meter used to assess peripheral oxygen saturation
Measured: 6 weeks
dyspnea borg scale
This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal
Measured: 6 weeks
postural tachycardia syndrome
the heart rate measured by pulse oxy-meter which applied on the index finger
Measured: 6 weeks
blood pressure (mmHg)
a sphygmomanometer will be used to measure the blood pressure (systolic and diastolic values)
Measured: 6 weeks
lactate level
venous blood sample will be drawn to assess blood lactate level. normal blood lactate level equal or less than 1 mmol/l
Measured: 6 weeks
fatigue severity scale (0-63)
The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on patients. The FSS is a short questionnaire that requires the patient to rate his level of fatigue.
The FSS questionnaire contains nine statements that rate the severity of the fatigue symptoms from 1 to 7, based on how accurately it reflects patient condition during the past week and the extent to which agree or disagree that statement
- A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement.
- A total score of less than 36 suggests suffering from fatigue. A total score of 36 or more suggests needing further evaluation by a physician
Measured: 6 weeks
Patient health questionnaire (PHQ-9)
it is a reliable and valid measure of depression severity as it is a self reporting questionnaire from 1to 27. A low value (e.g.,1) indicates minimal depression while a high value (e.g., 27) indicates severe depression
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Aug 2021
- Primary completion23 Nov 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 Covid19Studies 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
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Nabil, Cairo University
- Investigators
- Ebtesam N Nagy, doctoral, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919031
- Sponsor's protocol ID
- P.T.REC/012/003228
- Status last verified
- Feb 2023
- First submitted
- 7 Jun 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Trainer Impact on Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Hypertensive Patients With Long Term Persistent Symptoms
- ClinicalTrials.gov ID
- NCT04919031
- Acronym / sponsor ID
- P.T.REC/012/003228
- Conditions
- Covid19, Hypertension, Corona Persistent Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 9 Jun 2021 (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.
Inspiratory muscle training considered as safe and valid method to improve respiratory muscle strength and functional capacity among uncountable conditions which could improve post COVID-19 persistent symptoms including but not limited to respiratory muscle strength, diminishing dyspnea, enhance blood oxygenation, and patient's functional capacity and quality of life.
Detailed description
The current COVID-19 pandemic will place enormous pressure on healthcare systems around the world. The COVID-19 pandemic continues to dominate our daily lives with large numbers of people are predicted to become critically ill with acute respiratory distress syndrome and will require management in intensive care units. Unfortunately, it is expected that COVID-19 will persist as a major challenge for the delivery of medical care for a long while to go. High levels of physical, cognitive, and psychosocial impairments can be anticipated and persist after discharging from hospitals. Growing data shows a higher risk of COVID-19 infections and complications in people with high blood pressure affecting between 30% to 50% of the patients.
Intensive care unit- acquired weakness is very common after ARDS (COVID 19) which confers a major determinant of poor long-term functional, respiratory and psychological outcome.
Patients with coronavirus disease (COVID-19) are described as exhibiting oxygen levels incompatible with life with dyspnea. Pulse oximeter is valid device used to assess oxygen level in the blood as well as the pulse rate. As case numbers grow, neurological symptoms have been reported with increasing the frequency of corona virus infection, including those of autonomic dysfunction. It was reported that many patients developed postural tachycardia syndrome (POTS) several months after confirmed SARSCoV- 2 infection especially those with cardiovascular risk factors. Based on knowledge from the multiple systemic complications associated with Covid-19, it is reasonable to suggest that most patients, especially those who underwent prolonged hospitalization with one or more cardiovascular risk factor, will need a multi professional rehabilitation program.
Respiratory rehabilitation aims to improve quality of life by managing dyspnea, improving exercise tolerance and increasing functional capacity. After initial recovery from Covid-19, especially for those who required hospitalization in ICU, it is possible that some patients may experience respiratory muscle dysfunction, as well as pulmonary restriction or obstruction to varying extents, affecting peripheral muscle function and respiratory conditioning.
Several previous studies explained that inspiratory muscle training (IMT) is a feasible and safe modality in patients with respiratory muscle dysfunction which approve its efficacy in enhancing respiratory muscle strength, improving aerobic capacity, and diminishing dyspnea among patients suffering from COVID 19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Device: Inspiratory muscle trainer, Other: diaphragmatic releaseInspiratory muscle trainer plus diaphragmatic release and traditional medications |
| control | Active comparator | Device: Inspiratory muscle trainerinspiratory muscle trainer plus traditional medications |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- sixty non hospitalized negative post covid-19
- men
- cigarette smokers
- 40-60 years old
- stage II Hypertensive (160-179 / 100-109 mmHg)
Key exclusion criteria (11 listed)
- Patients with red flag indicators as chest pain, critical drop of oxygen saturation which require oxygen supply, severe level of hypoxia (blue lips)
- Unconscious patient
- Positive covid-19 patients
- Patients with cognitive impairment
- End-stage of chronic diseases
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 |
|---|---|---|
| Inspiratory muscle trainerPOWER breathe IMT is a drug-free, hand-held breathing training device. The medical term for this type of breathing training is Inspiratory Muscle Training, or IMT. POWER breathe IMT exercises the main muscles you use to breathe in, primarily your diaphragm and intercostal | Device | control, study |
| diaphragmatic releasediaphragmatic release is a manual technique use for restoring the ability of the diaphragm to go through a full range of motion | Other | study |
Primary outcome
maximal inspiratory pressure
Time frame: 6 weeks
For determining MIP, patients breathe through a flanged mouthpiece with nose clips in place. They are instructed to exhale to RV. At RV, a valve or shutter is closed, and the patient is coached to inhale as forcefully as possible. Maximum pull should be maintained for 1-2 seconds.
11 secondary outcomes
sleeping quality scale
Time frame: 6 weeks
Timed stair climbing
Time frame: 6 weeks
6 minute walk test
Time frame: 6 weeks
modified medical research council (mMRC) scale (0-4)
Time frame: 6 weeks
Oxygen saturation
Time frame: 6 weeks
dyspnea borg scale
Time frame: 6 weeks
postural tachycardia syndrome
Time frame: 6 weeks
blood pressure (mmHg)
Time frame: 6 weeks
lactate level
Time frame: 6 weeks
fatigue severity scale (0-63)
Time frame: 6 weeks
Patient health questionnaire (PHQ-9)
Time frame: 6 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 8 Feb 2023.
- Individual participant dataSharing planned: Yes
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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.
Ebtesam N Nagy, doctoral principal investigator
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 Inspiratory muscle trainer and diaphragmatic release in people with Covid19 and Hypertension, 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 10 inclusion and 11 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 8 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?
maximal inspiratory pressure (time frame: 6 weeks). 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 8 Feb 2023.