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

Sponsor

DR. JASSIM ALGHAITH (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04617119

Collaborator

(none)

Enrollment

Location

Arms

5.1

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A pilot study following a randomized controlled trial design.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

Anticipated Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Feb 6, 2021

Anticipated Study Completion Date :

Apr 6, 2021

Arms and Interventions

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

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

Primary Outcome Measures

Changes in Respiratory muscle performance [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jaber Al-Ahmed Hospital	Kuwait city		Kuwait

Sponsors and Collaborators

DR. JASSIM ALGHAITH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

DR. JASSIM ALGHAITH, Specialist physical therapist, PhD., Ministry of Health, Kuwait

ClinicalTrials.gov Identifier:

NCT04617119

Other Study ID Numbers:

JALGHAITH

First Posted:

Nov 5, 2020

Last Update Posted:

Nov 5, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

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, Specialist physical therapist, PhD., Ministry of Health, Kuwait

Respiratory muscle strength

Inspiratory muscle training

Respiratory physical therapy

Patient exercise training

Maximal inspiratory pressure

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Nov 5, 2020