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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

Tracking Information
First Submitted Date  ICMJE October 28, 2020
First Posted Date  ICMJE November 5, 2020
Last Update Posted Date November 5, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date February 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2020)
  • Blood pressure [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    Blood pressure measured by electronic BP machine before and after session
  • Heart rate [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    measured by heart rate monitor before and after session
  • Oxygen saturation [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    Measured by pulse oximeter before and after session
  • Oxygen supplementation [ Time Frame: Daily from baseline to hospital discharge (2 weeks). ]
    Number of % of oxygen patient on it before and after session
  • 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.
  • 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.
  • 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.
  • Respiratory rate [ Time Frame: Daily from baseline to hospital discharge (2 weeks) ]
    Measured by Respiratory rate monitor. Before and after session
  • Threshold IMT device [ Time Frame: Daily from baseline to 1 month from admission ]
    Recording number for breath and sets daily.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU
Official Title  ICMJE The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Covid19
  • Severe Systemic Illness Respiratory Muscle Fatigue
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Device: Threshold IMT device
    • Other: Conventional physical therapy
  • Active Comparator: Conventional physical therapy
    The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
    Intervention: Other: Conventional physical therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2020)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 6, 2021
Estimated Primary Completion Date February 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jassim M Alghaith, PhD. (965)99558185 Alghaith328@gmail.com
Contact: Abdulaziz Al-Husaini, MSc. health_aura@hotmail.com
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04617119
Other Study ID Numbers  ICMJE JALGHAITH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: not decided yet
Responsible Party DR. JASSIM ALGHAITH, Ministry of Health, Kuwait
Study Sponsor  ICMJE DR. JASSIM ALGHAITH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ministry of Health, Kuwait
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP