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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04617119
• Other study ID #: JALGHAITH
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: April 6, 2021

Study information

• Verified date: November 2020
• Source: Ministry of Health, Kuwait
• Contact: Jassim M Alghaith, PhD.
• Phone: (965)99558185
• Email: Alghaith328[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: April 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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:

1. Respiratory rate at = 20 breath.min-1.

2. Oxygen saturation (SatO2) = 90% at rest on room air.

3. Arterial partial pressure of oxygen (PaO2) = 80 mmHg at resting.

4. 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:

1. Patient that has received upper abdominal or thoracic surgery recently (= 3 months).

2. Cancer patients.

3. Pregnant patients.

4. Patient mentally unstable.

5. Patient with unstable cardiovascular or neurological functions.

6. Patients refusing to participate in this clinical trial.

7. Patient less the 21 years old (According to Kuwaiti Law).

8. Patients who have a language barrier who cannot understand Arabic or English.

Related Conditions & MeSH terms

• Covid19
• Fatigue
• Severe Systemic Illness Respiratory Muscle Fatigue

Intervention

Device:
• Threshold IMT device
10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.

Other:
• Conventional physical therapy
daily

Locations

Country	Name	City	State
Kuwait	Jaber Al-Ahmed Hospital	Kuwait city

Sponsors (1)

Lead Sponsor	Collaborator
DR. JASSIM ALGHAITH

Country where clinical trial is conducted

Kuwait, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1st week, 2nd week, one month
Secondary	Blood pressure	Blood pressure measured by electronic BP machine before and after session	Daily from baseline to hospital discharge (2 weeks)
Secondary	Heart rate	measured by heart rate monitor before and after session	Daily from baseline to hospital discharge (2 weeks)
Secondary	Oxygen saturation	Measured by pulse oximeter before and after session	Daily from baseline to hospital discharge (2 weeks)
Secondary	Oxygen supplementation	Number of % of oxygen patient on it before and after session	Daily from baseline to hospital discharge (2 weeks).
Secondary	Oxygen flow rate	measuring the number of time where the oxygen above or below 4L/min.	Daily from baseline to hospital discharge (2 weeks)
Secondary	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.	Daily from baseline to hospital discharge (2 weeks)
Secondary	Pain level	By using visual analogue scale. Possible score range from 0 (no pain) to 10 (worst possible pain) Before and after session.	Daily from baseline to hospital discharge (2 weeks)
Secondary	Respiratory rate	Measured by Respiratory rate monitor. Before and after session	Daily from baseline to hospital discharge (2 weeks)
Secondary	Threshold IMT device	Recording number for breath and sets daily.	Daily from baseline to 1 month from admission