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Trial record 24 of 910 for:    Not yet recruiting, Available Studies | Covid19 | Adult
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The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU

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ClinicalTrials.gov Identifier: NCT04617119
Recruitment Status : Not yet recruiting
First Posted : November 5, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
DR. JASSIM ALGHAITH, Ministry of Health, Kuwait

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Severe Systemic Illness Respiratory Muscle Fatigue Device: Threshold IMT device Other: Conventional physical therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pilot study following a randomized controlled trial design.
Masking: Double (Participant, 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.
Primary Purpose: Prevention
Official Title: The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : February 6, 2021
Estimated Study Completion Date : April 6, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    Blood pressure measured by electronic BP machine before and after session

  2. Heart rate [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    measured by heart rate monitor before and after session

  3. Oxygen saturation [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    Measured by pulse oximeter before and after session

  4. Oxygen supplementation [ Time Frame: Daily from baseline to hospital discharge (2 weeks). ]
    Number of % of oxygen patient on it before and after session

  5. 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.

  6. 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.


  7. 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.

  8. Respiratory rate [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    Measured by Respiratory rate monitor. Before and after session

  9. Threshold IMT device [ Time Frame: Daily from baseline to 1 month from admission ]
    Recording number for breath and sets daily.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04617119


Contacts
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Contact: Jassim M Alghaith, PhD. (965)99558185 Alghaith328@gmail.com
Contact: Abdulaziz Al-Husaini, MSc. health_aura@hotmail.com

Locations
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Kuwait
Jaber Al-Ahmed Hospital
Kuwait city, Kuwait
Sponsors and Collaborators
DR. JASSIM ALGHAITH
More Information
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Publications:
WHO, CORONAVIRUS DISEASE (COVID-19) OUTBREAK: RIGHTS, ROLES AND RESPONSIBILITIES OF HEALTH WORKERS, INCLUDING KEY CONSIDERATIONS FOR OCCUPATIONAL SAFETY AND HEALTH 2020.
Cascella, M., et al., Features, evaluation and treatment coronavirus (COVID-19), in Statpearls [internet]. 2020, StatPearls Publishing.

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Responsible Party: DR. JASSIM ALGHAITH, Specialist physical therapist, PhD., Ministry of Health, Kuwait
ClinicalTrials.gov Identifier: NCT04617119    
Other Study ID Numbers: JALGHAITH
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not decided yet

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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
Keywords provided by DR. JASSIM ALGHAITH, Ministry of Health, Kuwait:
Respiratory muscle strength
Inspiratory muscle training
Respiratory physical therapy
Patient exercise training
Maximal inspiratory pressure
Additional relevant MeSH terms:
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Fatigue