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

November 4, 2020 updated by: DR. JASSIM ALGHAITH

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kuwait
      • Kuwait city, Kuwait
        • Jaber Al-Ahmed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional physical therapy treatment and IMT

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
10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.
Other: Conventional physical therapy
daily
Active Comparator: Conventional physical therapy
The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
Other: Conventional physical therapy
daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Respiratory muscle performance
Time Frame: 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.
Baseline, 1st week, 2nd week, one month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DR. JASSIM ALGHAITH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

February 6, 2021

Study Completion (Anticipated)

April 6, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JALGHAITH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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