Back to resultsThe Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU
Primary Purpose
Covid19, Severe Systemic Illness Respiratory Muscle Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Threshold IMT device
Conventional physical therapy
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Respiratory muscle strength, Inspiratory muscle training, Respiratory physical therapy, Patient exercise training, Maximal inspiratory pressure
Eligibility Criteria
Inclusion Criteria:
Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:
- Respiratory rate at ≥ 20 breath.min-1.
- Oxygen saturation (SatO2) ≤ 90% at rest on room air.
- Arterial partial pressure of oxygen (PaO2) ≤ 80 mmHg at resting.
- PaO2/FiO2 ratio or P/F (is the ratio between the arterial partial pressure of oxygen and the percentage of oxygen supplied) < 300mmHg.
Exclusion Criteria:
- Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
- Cancer patients.
- Pregnant patients.
- Patient mentally unstable.
- Patient with unstable cardiovascular or neurological functions.
- Patients refusing to participate in this clinical trial.
- Patient less the 21 years old (According to Kuwaiti Law).
- Patients who have a language barrier who cannot understand Arabic or English.
Sites / Locations
- Jaber Al-Ahmed Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional physical therapy treatment and IMT
Conventional physical therapy
Arm Description
The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. In addition, the patient will receive inspiratory muscle training (IMT) by using a threshold IMT device. Patient will ask to use the device twice daily. In each time, patient will perform 3 sets of 10 breaths with 1-minute rest between sets. Exercise intensity will start with 10 % of pre-measured maximal inspiratory pressure. Once the patient successfully completed 30 breath twice a day, the exercise load will increase 5% more in the subsequent training session. This treatment protocol will perform daily for 2 weeks.
The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
Outcomes
Primary Outcome Measures
Changes in Respiratory muscle performance
Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak.
Secondary Outcome Measures
Blood pressure
Blood pressure measured by electronic BP machine before and after session
Heart rate
measured by heart rate monitor before and after session
Oxygen saturation
Measured by pulse oximeter before and after session
Oxygen supplementation
Number of % of oxygen patient on it before and after session
Oxygen flow rate
measuring the number of time where the oxygen above or below 4L/min.
Dyspnoea level
By using Borg scale (rating of perceived exertion scale), Possible score range from 0 (nothing) to 10 ( Maximal exertion).
Before and after session.
Pain level
By using visual analogue scale. Possible score range from 0 (no pain) to 10 (worst possible pain) Before and after session.
Respiratory rate
Measured by Respiratory rate monitor. Before and after session
Threshold IMT device
Recording number for breath and sets daily.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04617119
Brief Title
The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU
Official Title
The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
February 6, 2021 (Anticipated)
Study Completion Date
April 6, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DR. JASSIM ALGHAITH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Severe Systemic Illness Respiratory Muscle Fatigue
Keywords
Respiratory muscle strength, Inspiratory muscle training, Respiratory physical therapy, Patient exercise training, Maximal inspiratory pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pilot study following a randomized controlled trial design.
Masking
ParticipantOutcomes Assessor
Masking Description
COVID-19 patient will be blinded from the study aim. The outcomes assessor will be blinded from the study aim and patient allocation.
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional physical therapy treatment and IMT
Arm Type
Experimental
Arm Description
The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
In addition, the patient will receive inspiratory muscle training (IMT) by using a threshold IMT device. Patient will ask to use the device twice daily. In each time, patient will perform 3 sets of 10 breaths with 1-minute rest between sets.
Exercise intensity will start with 10 % of pre-measured maximal inspiratory pressure.
Once the patient successfully completed 30 breath twice a day, the exercise load will increase 5% more in the subsequent training session.
This treatment protocol will perform daily for 2 weeks.
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
Intervention Type
Device
Intervention Name(s)
Threshold IMT device
Intervention Description
10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
daily
Primary Outcome Measure Information:
Title
Changes in Respiratory muscle performance
Description
Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak.
Time Frame
Baseline, 1st week, 2nd week, one month
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure measured by electronic BP machine before and after session
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Heart rate
Description
measured by heart rate monitor before and after session
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Oxygen saturation
Description
Measured by pulse oximeter before and after session
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Oxygen supplementation
Description
Number of % of oxygen patient on it before and after session
Time Frame
Daily from baseline to hospital discharge (2 weeks).
Title
Oxygen flow rate
Description
measuring the number of time where the oxygen above or below 4L/min.
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Dyspnoea level
Description
By using Borg scale (rating of perceived exertion scale), Possible score range from 0 (nothing) to 10 ( Maximal exertion).
Before and after session.
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Pain level
Description
By using visual analogue scale. Possible score range from 0 (no pain) to 10 (worst possible pain) Before and after session.
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Respiratory rate
Description
Measured by Respiratory rate monitor. Before and after session
Time Frame
Daily from baseline to hospital discharge (2 weeks)
Title
Threshold IMT device
Description
Recording number for breath and sets daily.
Time Frame
Daily from baseline to 1 month from admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:
Respiratory rate at ≥ 20 breath.min-1.
Oxygen saturation (SatO2) ≤ 90% at rest on room air.
Arterial partial pressure of oxygen (PaO2) ≤ 80 mmHg at resting.
PaO2/FiO2 ratio or P/F (is the ratio between the arterial partial pressure of oxygen and the percentage of oxygen supplied) < 300mmHg.
Exclusion Criteria:
Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
Cancer patients.
Pregnant patients.
Patient mentally unstable.
Patient with unstable cardiovascular or neurological functions.
Patients refusing to participate in this clinical trial.
Patient less the 21 years old (According to Kuwaiti Law).
Patients who have a language barrier who cannot understand Arabic or English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jassim M Alghaith, PhD.
Phone
(965)99558185
Email
Alghaith328@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulaziz Al-Husaini, MSc.
Email
health_aura@hotmail.com
Facility Information:
Facility Name
Jaber Al-Ahmed Hospital
City
Kuwait city
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided yet
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The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU
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