Covid19, Severe Systemic Illness Respiratory Muscle Fatigue
Conditions
Keywords
Respiratory muscle strength, Inspiratory muscle training, Respiratory physical therapy, Patient exercise training, Maximal inspiratory pressure
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.
Interventions
DEVICEThreshold IMT device
10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.
OTHERConventional physical therapy
daily
Sponsors
DR. JASSIM ALGHAITH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes 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.
Intervention model description
A pilot study following a randomized controlled trial design.
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Daily from baseline to hospital discharge (2 weeks) | measured by heart rate monitor before and after session |
| Oxygen saturation | Daily from baseline to hospital discharge (2 weeks) | Measured by pulse oximeter 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 |
| Oxygen flow rate | Daily from baseline to hospital discharge (2 weeks) | measuring the number of time where the oxygen above or below 4L/min. |
| Blood pressure | Daily from baseline to hospital discharge (2 weeks) | Blood pressure measured by electronic BP machine 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 |
| Threshold IMT device | Daily from baseline to 1 month from admission | Recording number for breath and sets daily. |
| 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. |
Countries
Kuwait
Contacts
Primary ContactJassim M Alghaith, PhD.
Backup ContactAbdulaziz Al-Husaini, MSc.
Outcome results
None listed