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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19, Severe Systemic Illness Respiratory Muscle Fatigue

Intervention / Treatment
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* Device: Threshold IMT device
* Other: Conventional physical therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pilot study following a randomized controlled trial design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional physical therapy treatment and IMT<br>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. | Device: Threshold IMT device<br>* 10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.<br>Other: Conventional physical therapy<br>* daily<br>|
| Active Comparator: Conventional physical therapy<br>The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. | Other: Conventional physical therapy<br>* daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure measured by electronic BP machine before and after session | Daily from baseline to hospital discharge (2 weeks) | 
| Heart rate | measured by heart rate monitor before and after session | Daily from baseline to hospital discharge (2 weeks) | 
| Oxygen saturation | Measured by pulse oximeter before and after session | Daily from baseline to hospital discharge (2 weeks) | 
| Oxygen supplementation | Number of % of oxygen patient on it before and after session | Daily from baseline to hospital discharge (2 weeks). | 
| Oxygen flow rate | measuring the number of time where the oxygen above or below 4L/min. | Daily from baseline to hospital discharge (2 weeks) | 
| 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) | 
| 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) | 
| Respiratory rate | Measured by Respiratory rate monitor. Before and after session | Daily from baseline to hospital discharge (2 weeks) | 
| Threshold IMT device | Recording number for breath and sets daily. | Daily from baseline to 1 month from admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory muscle strength, Inspiratory muscle training, Respiratory physical therapy, Patient exercise training, Maximal inspiratory pressure