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

Not Applicable

• Conditions: Covid19; Severe Systemic Illness Respiratory Muscle Fatigue
• Interventions: Device: Threshold IMT device; Other: Conventional physical therapy

• Registration Number: NCT04617119
• Lead Sponsor: DR. JASSIM ALGHAITH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-28
• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05
• Primary Completion: 2021-02-06
• Study Completion: 2021-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physical therapy treatment and IMT	Threshold IMT device	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.
Conventional physical therapy	Conventional physical therapy	The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
Conventional physical therapy treatment and IMT	Conventional physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Changes in Respiratory muscle performance	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 Outcome Measures

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

Trial Locations

Locations (1)

Jaber Al-Ahmed Hospital; 🇰🇼 Kuwait city, Kuwait