Clinical trial NCT04617119: The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU
Official title: The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Severe Systemic Illness Respiratory Muscle Fatigue
Keywords: Respiratory muscle strength
Inspiratory muscle training
Respiratory physical therapy
Patient exercise training
Maximal inspiratory pressure
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2020-11-05
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot study following a randomized controlled trial design.
Primary purpose: PREVENTION

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.


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:

  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.

Primary outcomes:
measure: Changes in Respiratory muscle performance
timeFrame: Baseline, 1st week, 2nd week, one month
Secondary outcomes:
measure: Blood pressure
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Heart rate
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Oxygen saturation
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Oxygen supplementation
timeFrame: Daily from baseline to hospital discharge (2 weeks).
measure: Oxygen flow rate
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Dyspnoea level
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Pain level
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Respiratory rate
timeFrame: Daily from baseline to hospital discharge (2 weeks)
measure: Threshold IMT device
timeFrame: Daily from baseline to 1 month from admission
Other outcomes:
Locations:
city: Kuwait city
country: Kuwait
facility: Jaber Al-Ahmed Hospital
Study officials:
References:
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