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

NCT04617119 | Unknown FDA Device

• 1 other identifier: JALGHAITH
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Severe Systemic Illness Respiratory Muscle Fatigue

Keywords

Respiratory muscle strength; Inspiratory muscle training; Respiratory physical therapy; Patient exercise training; Maximal inspiratory pressure

Outcome Measures

Primary Outcomes (1)

• Changes in Respiratory muscle performance

  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 Outcomes (9)

• Blood pressure

  Daily from baseline to hospital discharge (2 weeks)

• Heart rate

  Daily from baseline to hospital discharge (2 weeks)

• Oxygen saturation

  Daily from baseline to hospital discharge (2 weeks)

• Oxygen supplementation

  Daily from baseline to hospital discharge (2 weeks).

• Oxygen flow rate

  Daily from baseline to hospital discharge (2 weeks)

Study Arms (2)

Conventional physical therapy treatment and IMT

EXPERIMENTAL

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; Other: Conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.

Other: Conventional physical therapy

Interventions

Threshold IMT device DEVICE

10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.

Conventional physical therapy treatment and IMT

Conventional physical therapy OTHER

daily

Conventional physical therapy; Conventional physical therapy treatment and IMT

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Respiratory rate at ≥ 20 breath.min-1.
• Oxygen saturation (SatO2) ≤ 90% at rest on room air.
• Arterial partial pressure of oxygen (PaO2) ≤ 80 mmHg at resting.
• PaO2/FiO2 ratio or P/F (is the ratio between the arterial partial pressure of oxygen and the percentage of oxygen supplied) \< 300mmHg.

You may not qualify if:

• Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
• Cancer patients.
• Pregnant patients.
• Patient mentally unstable.
• Patient with unstable cardiovascular or neurological functions.
• Patients refusing to participate in this clinical trial.
• Patient less the 21 years old (According to Kuwaiti Law).
• Patients who have a language barrier who cannot understand Arabic or English.

Sponsors & Collaborators

• DR. JASSIM ALGHAITH: lead

Study Sites (1)

Jaber Al-Ahmed Hospital

Kuwait City, Kuwait

Location

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jassim M Alghaith, PhD.

CONTACT

(965)99558185; Alghaith328@gmail.com

Abdulaziz Al-Husaini, MSc.

CONTACT

health_aura@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: COVID-19 patient will be blinded from the study aim. The outcomes assessor will be blinded from the study aim and patient allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist physical therapist, PhD.

Model Details: A pilot study following a randomized controlled trial design.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 5, 2020
• Study Start: November 1, 2020
• Primary Completion: February 6, 2021
• Study Completion: April 6, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

KU (1)