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

Primary Purpose

Covid19, Hypertension, Corona Persistent Symptoms

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Inspiratory muscle trainer
diaphragmatic release
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

40 Years - 60 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study

control

Arm Description

Inspiratory muscle trainer plus diaphragmatic release and traditional medications

inspiratory muscle trainer plus traditional medications

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Timed stair climbing
Total time to ascend and descend steps is recorded to the nearest 100th of a second. Lower values = better performance
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.
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
Oxygen saturation
pulse ox meter used to assess peripheral oxygen saturation
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
postural tachycardia syndrome
the heart rate measured by pulse oxy-meter which applied on the index finger
blood pressure (mmHg)
a sphygmomanometer will be used to measure the blood pressure (systolic and diastolic values)
lactate level
venous blood sample will be drawn to assess blood lactate level. normal blood lactate level equal or less than 1 mmol/l
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
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

Full Information

First Posted
June 7, 2021
Last Updated
February 6, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04919031
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 23, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hypertension, Corona Persistent Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study
Arm Type
Experimental
Arm Description
Inspiratory muscle trainer plus diaphragmatic release and traditional medications
Arm Title
control
Arm Type
Active Comparator
Arm Description
inspiratory muscle trainer plus traditional medications
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle trainer
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
diaphragmatic release
Intervention Description
diaphragmatic release is a manual technique use for restoring the ability of the diaphragm to go through a full range of motion
Primary Outcome Measure Information:
Title
maximal inspiratory pressure
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
sleeping quality scale
Description
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.
Time Frame
6 weeks
Title
Timed stair climbing
Description
Total time to ascend and descend steps is recorded to the nearest 100th of a second. Lower values = better performance
Time Frame
6 weeks
Title
6 minute walk test
Description
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.
Time Frame
6 weeks
Title
modified medical research council (mMRC) scale (0-4)
Description
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
Time Frame
6 weeks
Title
Oxygen saturation
Description
pulse ox meter used to assess peripheral oxygen saturation
Time Frame
6 weeks
Title
dyspnea borg scale
Description
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
Time Frame
6 weeks
Title
postural tachycardia syndrome
Description
the heart rate measured by pulse oxy-meter which applied on the index finger
Time Frame
6 weeks
Title
blood pressure (mmHg)
Description
a sphygmomanometer will be used to measure the blood pressure (systolic and diastolic values)
Time Frame
6 weeks
Title
lactate level
Description
venous blood sample will be drawn to assess blood lactate level. normal blood lactate level equal or less than 1 mmol/l
Time Frame
6 weeks
Title
fatigue severity scale (0-63)
Description
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
Time Frame
6 weeks
Title
Patient health questionnaire (PHQ-9)
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebtesam N Nagy, doctoral
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
one year after study actual completion date

Learn more about this trial

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

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