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Clinical Trials/NCT04617119
NCT04617119
Unknown
Not Applicable

The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study

DR. JASSIM ALGHAITH1 site in 1 country38 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
DR. JASSIM ALGHAITH
Enrollment
38
Locations
1
Primary Endpoint
Changes in Respiratory muscle performance
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
April 6, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
DR. JASSIM ALGHAITH
Responsible Party
Sponsor Investigator
Principal Investigator

DR. JASSIM ALGHAITH

Specialist physical therapist, PhD.

Ministry of Health, Kuwait

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-
  • 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.

Outcomes

Primary Outcomes

Changes in Respiratory muscle performance

Time Frame: Baseline, 1st week, 2nd week, one month

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 Outcomes

  • Oxygen saturation(Daily from baseline to hospital discharge (2 weeks))
  • Threshold IMT device(Daily from baseline to 1 month from admission)
  • Heart rate(Daily from baseline to hospital discharge (2 weeks))
  • Oxygen supplementation(Daily from baseline to hospital discharge (2 weeks).)
  • Blood pressure(Daily from baseline to hospital discharge (2 weeks))
  • Dyspnoea level(Daily from baseline to hospital discharge (2 weeks))
  • Pain level(Daily from baseline to hospital discharge (2 weeks))
  • Respiratory rate(Daily from baseline to hospital discharge (2 weeks))
  • Oxygen flow rate(Daily from baseline to hospital discharge (2 weeks))

Study Sites (1)

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