NCT05517941

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

August 24, 2022

Last Update Submit

June 12, 2023

Conditions

Keywords

active cycle breathingincentive spirometercovid19

Outcome Measures

Primary Outcomes (1)

  • arterial blood gas

    arterial blood gas analysis will be measured using arterial blood sample

    up to two weeks

Secondary Outcomes (2)

  • C-reactive protein

    up to two weeks

  • Oxygen saturation

    up to two weeks

Study Arms (2)

active cycle breathing exercise

EXPERIMENTAL

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

Other: active cycle breathing

incentive spirometer

EXPERIMENTAL

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

Other: active cycle breathingOther: incentive spirometer

Interventions

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

active cycle breathing exerciseincentive 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.

incentive spirometer

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El sheikh zayed Al nahyan hospital

Giza, 11251, Egypt

Location

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: active cycle breathing and incentive spirometer
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator. alshaymaa shaaban abd el-azeim

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

September 15, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations