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Inspiratory Muscle Trainer and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Persistent Symptoms

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Hypertension
Covid19
Corona Persistent Symptoms

Treatments

Device: Inspiratory muscle trainer
Other: diaphragmatic release

Study type

Interventional

Funder types

Other

Identifiers

NCT04919031
P.T.REC/012/003228

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Male

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

study
Experimental group
Description:
Inspiratory muscle trainer plus diaphragmatic release and traditional medications
Treatment:
Device: Inspiratory muscle trainer
Other: diaphragmatic release
control
Active Comparator group
Description:
inspiratory muscle trainer plus traditional medications
Treatment:
Device: Inspiratory muscle trainer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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