Clinical trial NCT04919031: Inspiratory Muscle Trainer and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Persistent Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Hypertension
Corona Persistent Symptoms
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 90
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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%
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: maximal inspiratory pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: sleeping quality scale
timeFrame: 6 weeks
measure: Timed stair climbing
timeFrame: 6 weeks
measure: 6 minute walk test
timeFrame: 6 weeks
measure: modified medical research council (mMRC) scale (0-4)
timeFrame: 6 weeks
measure: Oxygen saturation
timeFrame: 6 weeks
measure: dyspnea borg scale
timeFrame: 6 weeks
measure: postural tachycardia syndrome
timeFrame: 6 weeks
measure: blood pressure (mmHg)
timeFrame: 6 weeks
measure: lactate level
timeFrame: 6 weeks
measure: fatigue severity scale (0-63)
timeFrame: 6 weeks
measure: Patient health questionnaire (PHQ-9)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: Ebtesam N Nagy, doctoral
role: PRINCIPAL_INVESTIGATOR
References: