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CompletedNCT05517941COVID19Updated Jun 13, 2023

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

An interventional study of active cycle breathing and incentive spirometer in Corona Virus Infection, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study summary

this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient

Read the 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

02

Conditions studied

  • Corona Virus Infection

Keywords

  • active cycle breathing
  • incentive spirometer
  • covid19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    active cycle breathing exercise

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

    Other: active cycle breathing

  • Experimental
    incentive spirometer

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

    Other: active cycle breathing · Other: incentive spirometer

Interventions

  • Otheractive cycle breathing

    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

  • Otherincentive spirometer

    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.

06

What researchers measure

Primary outcomes

  1. arterial blood gas

    arterial blood gas analysis will be measured using arterial blood sample

    Time frame: up to two weeks

Secondary outcomes

  1. C-reactive protein

    C-reactive protein will be measured by blood sample analysis

    Time frame: up to two weeks

  2. Oxygen saturation

    SpO2 will be measure by pulse oximeter

    Time frame: up to two weeks

07

Study locations

1 site
  • El sheikh zayed Al nahyan hospital
    Giza, 11251, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05517941
Lead sponsor
Cairo University
Responsible party
Al Shaymaa Shaaban Abd El Azeim (principle investigator. alshaymaa shaaban abd el-azeim, Cairo University) — Principal investigator
First posted
Aug 26, 2022
Start date
Sep 15, 2022
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Jun 13, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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