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

D

DR. JASSIM ALGHAITH

Status

Unknown

Conditions

Severe Systemic Illness Respiratory Muscle Fatigue
Covid19

Treatments

Device: Threshold IMT device
Other: Conventional physical therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04617119
JALGHAITH

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

Conventional physical therapy treatment and IMT
Experimental group
Description:
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.
Treatment:
Device: Threshold IMT device
Other: Conventional physical therapy
Conventional physical therapy
Active Comparator group
Description:
The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
Treatment:
Other: Conventional physical therapy

Trial contacts and locations

1

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Central trial contact

Abdulaziz Al-Husaini, MSc.; Jassim M Alghaith, PhD.

Data sourced from clinicaltrials.gov

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