search
Back to results

Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient (COVID19)

Primary Purpose

Corona Virus Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
active cycle breathing
incentive spirometer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Infection focused on measuring active cycle breathing, incentive spirometer, covid19

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages from 45-75 years old
  • COVID-19 patients with SpO2 > 85
  • oxygen face Mask or a reservoir mask

Exclusion Criteria:

  • Mechanically ventilated,
  • Cancer,
  • Chronic respiratory disease (defined as asthma or chronic obstructive pulmonary disease),
  • End-stage renal disease,
  • Liver disease (defined as compensated/decompensated liver cirrhosis),
  • Chronic neurological disease (defined as previous neurological disease),
  • Chronic cardiovascular disease,
  • Active smoker

Sites / Locations

  • El sheikh zayed Al nahyan hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

active cycle breathing exercise

incentive spirometer

Arm Description

patients will receive Active cycle of breathing techniques daily for 2 weeks

patients will receive incentive spirometer and active cycle breathing daily for 2 weeks

Outcomes

Primary Outcome Measures

arterial blood gas
arterial blood gas analysis will be measured using arterial blood sample

Secondary Outcome Measures

C-reactive protein
C-reactive protein will be measured by blood sample analysis
Oxygen saturation
SpO2 will be measure by pulse oximeter

Full Information

First Posted
August 24, 2022
Last Updated
June 12, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05517941
Brief Title
Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
Acronym
COVID19
Official Title
Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient
Detailed Description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus that emerged in 2019 and causes coronavirus disease 2019 (COVID-19).Individuals with COVID-19 can present with an influenza-like illness and respiratory tract infection demonstrating fever (89%),cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%). The spectrum of disease severity ranges from asymptomatic infection or mild upper respiratory tract illness through to severe viral pneumonia with respiratory failure and/or death. Current reports estimate that 80% of cases are asymptomatic or mild; 15% of cases are severe (infection requiring oxygen); and 5% are critical, requiring ventilation and life support. Based on emerging data, individuals at the highest risk of developing severe COVID-19 disease requiring hospitalization and/or ICU support are those who are older, male, have at least one co-existing comorbidity, elevated D-dimer levels, and/or lymphocytopenia. Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable to individual patients. It assists bronchial clearance by enhancing mucociliary clearance whilst reducing adverse effects such as hypoxemia or increased airflow obstruction. Incentive spirometry (IS) is a type of deep breathing exercise that is widely used for lung expansion and the prevention of pulmonary complications in children, adults, and the elderly. IS is used to encourage the patient to inhale to lung capacity through maximal inspiration aided with visual feedback. These maneuvers increase transpulmonary pressure and therefore increase chest-wall volume.one hundred patients will be allocated randomly to two groups; one group will receive active cycle breathing with an incentive spirometer and the other will receive active cycle breathing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
Keywords
active cycle breathing, incentive spirometer, covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
active cycle breathing and incentive spirometer
Masking
ParticipantOutcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active cycle breathing exercise
Arm Type
Experimental
Arm Description
patients will receive Active cycle of breathing techniques daily for 2 weeks
Arm Title
incentive spirometer
Arm Type
Experimental
Arm Description
patients will receive incentive spirometer and active cycle breathing daily for 2 weeks
Intervention Type
Other
Intervention Name(s)
active cycle breathing
Intervention Description
The active cycle breathing technique will involve three steps: breathing control, thoracic expansion exercise, and forced expiration technique, In breathing control, the patient will sit comfortably in a chair and breathe at a normal rate and depth using the lower chest. In the thoracic expansion exercise, the physical therapist rested his/her hands on the patient's epigastrium and guided the patient's breathing so that they breathed at a slow and deep rate using the lower chest, then held their breath for 2 s and fully exhaled; this was repeated two or three times, then the patient returned to breathing control. For the forced expiration technique, the physical therapist asked the patient to inhale deeply while simultaneously contracting the abdominal muscle and keeping the mouth and throat open. They then held their breath for 2 s, followed by vigorous exhalation
Intervention Type
Other
Intervention Name(s)
incentive spirometer
Intervention Description
Incentive spirometry is accomplished by using a device that provides feedback when the patient inhales at a predetermined flow and sustains the inflation for at least 5 seconds. The patient is instructed to hold the spirometer in an upright position, exhale normally, and then place the lips tightly around the mouthpiece. The next step is a slow inhalation to raise the ball (flow-oriented) or the piston/ plate (volume-oriented) in the chamber to the set target. At maximum inhalation, the mouthpiece is removed, followed by a breath-hold and normal exhalation.
Primary Outcome Measure Information:
Title
arterial blood gas
Description
arterial blood gas analysis will be measured using arterial blood sample
Time Frame
up to two weeks
Secondary Outcome Measure Information:
Title
C-reactive protein
Description
C-reactive protein will be measured by blood sample analysis
Time Frame
up to two weeks
Title
Oxygen saturation
Description
SpO2 will be measure by pulse oximeter
Time Frame
up to two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages from 45-75 years old COVID-19 patients with SpO2 > 85 oxygen face Mask or a reservoir mask Exclusion Criteria: Mechanically ventilated, Cancer, Chronic respiratory disease (defined as asthma or chronic obstructive pulmonary disease), End-stage renal disease, Liver disease (defined as compensated/decompensated liver cirrhosis), Chronic neurological disease (defined as previous neurological disease), Chronic cardiovascular disease, Active smoker
Facility Information:
Facility Name
El sheikh zayed Al nahyan hospital
City
Giza
ZIP/Postal Code
11251
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient

We'll reach out to this number within 24 hrs