Respiratory Complication(ACBT)NCT06521346
Active Cycle Breathing Technique (ACBT) on Respiratory Parameters, Dyspnea Related Kinesiophobia and Pain
A study testing Active cycle breathing technique and Routine care in people with Respiratory Complication and Cardiac Disease, run by Damanhour University at 1 site in Egypt.
Trial summary
This study aims to improve pulmonary function impairment is associated with a reduction in chest expansion, lung volume, pain perception and an impairment of the Post cardiac surgery patient's ability to cough effectively. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Complication, Cardiac Disease
- What is being tested?
- Active cycle breathing technique and Routine care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients of both genders.
- After extubating for at least 6 hours post operation.
- Hemodynamic stable patients
- Able to communicate.
Who cannot join
- Instability of patient's medical condition or hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Active Cycle Breathing Technique on Respiratory Parameters, Dyspnea Related Kinesiophobia and Pain in Early Post Cardiac Surgery Patients
This study aims to improve pulmonary function impairment is associated with a reduction in chest expansion, lung volume, pain perception and an impairment of the Post cardiac surgery patient's ability to cough effectively. The technique of active cycle breathing consisted of three parts to the ACBT, which are:
- breathing control
- deep breaths
- huff or cough
Read the detailed description
This study aims to explore the effect of Active Cycle Breathing Technique on Respiratory Parameters and Pain in Early Post Cardiac Surgery Patients
Research hypothesis:
-Post cardiac surgery patients who practice active breathing techniques exhibit an improvement in clinical outcomes compared to those who do not practice.
Research design:
A randomized control trial research design will be utilized to conduct this study.
Study Setting:
This study was carried out at the cardiac ICUs. A sample of 120 cardiac patients will be assigned in the current study from the previously mentioned settings.
The patients will be allocated into two equal groups, each with 60 patients. The control group will be composed of 60 patients who were managed by routine cardiac care The study group will consist of 60 patients who were exposed to an active cycle of breathing techniques
Inclusion criteria:
- Adult patients of both genders.
- After extubating for at least 6 hours
- Hemodynamic stable patients
- Able to communicate. Exclusion criteria: Patient with complication postoperative surgery Patient's demographic characteristics as patient's code, age, gender, marital status, education, and occupation.
Study group: managed by the use of active cycle breathing techniques combined with routine physiotherapy.
- Each session of the active cycle breathing technique lasted for 10 to 20 minutes.
- The active cycle breathing technique was carried out for three days post extubating four sessions done daily.
Implementation of active cycle breathing technique
- Explain the steps of ACBT to the patient.
- The patient was placed in a semi-sitting position with her or his back straight, and instructions were given to the patient to do the following steps: 1 . Breathing control phase
- Hold the spirometer straight.
- Exhale, then seal your lips around the mouthpiece and inhale slowly and deeply into your mouth.
- The piston in the incentive spirometer's transparent chamber will rise when you inhale deeply.
- Hold your breath for 3 to 5 seconds after taking a deep breath.
- Remove the mouthpiece and slowly exhale. For a few seconds, until the piston descends to the bottom of the chamber, relax and breathe normally.
- To regain control of their breathing, the patient was told to do lengthy, slow expirations between 5 and 7 times. 2 . Thoracic expansion exercises The patient was instructed to relax your upper chest.
- The patient was instructed to breathe slowly and deeply through the nose without using the accessory muscle.
- The patient was instructed to hold their breath initially for 3 to 4 seconds and gradually increase it to the maximum time.
Don't force the breath out; instead, softly exhale through pursed lips until your lungs are empty.
- Repeat the previous steps from 3to4 times. 3- Forced expiration technique (huffing)
- Patient was instructed to support the incision site by using a chest binder or keeping your hands over your incision.
- Cough twice as many times as they huffed two to three times.
- This step was repeated a minimum of two times and a maximum of three times in one session.
- Conditions
- Respiratory Complication, Cardiac Disease
- Being tested
- Active cycle breathing technique, Routine care
- Keywords
- Respiratory function, Cardiac surgery
- Medical subject headings
- Heart Diseases, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle breathing techniqueProcedure or surgery
The ACBT was included if it was described as containing three essential components: 1) breathing control, 2) forced expiration technique and 3) thoracic expansion exercises. The technique may also include postural drainage (PD) or percussion/shaking.
Routine careProcedure or surgery
Routine care delivers after extubating such as percussion or chest physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Active cycle breathing technique | Experimental | Breathing control phase Thoracic expansion exercises Forced expiration technique (huffing) Receives: Procedure: Active cycle breathing technique |
| Control group | Placebo comparator | Patient who receives the routine care Receives: Procedure: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory parameters
change in respiratory rate
Measured: Three observation days
Pain perception
Using visual analogue scale score 0 mean no pain while score 10 means sever pain
Measured: Three observation days
Dyspnea-related kinesiophobia
comprises 11 items include five items dyspnea and six items for fear of activity dimension and each item is rated from "strongly disagree" (score = 1) to "strongly agree" (score = 5) for a total score between 11 and 55.
Measured: preoperative, three observation days, and day of discharge
Secondary outcomes (2)
Deterioration in clinical parameters such as vital signs
hypoxic event
Measured: Three observation days
ICU and hospital stay
ICU and hospital stay
Measured: three observation days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Dec 2024
- Primary completion1 Jul 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The total group will be divided into two group: control and intervention group Control group receives standard care in the unit Intervention group receives active cycle breathing techniques
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521346
- Sponsor's protocol ID
- Active cycle breath technique
- Acronym
- (ACBT)
- Status last verified
- Dec 2025
- First submitted
- 19 Jul 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
PubMed 22100537Mckoy NA, Wilson LM, Saldanha IJ, Odelola OA, Robinson KA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2016 Jul 5;7(7):CD007862. doi: 10.1002/14651858.CD007862.pub4.
PubMed 27378490
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active Cycle Breathing Technique on Respiratory Parameters, Dyspnea Related Kinesiophobia and Pain in Early Post Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06521346
- Acronym / sponsor ID
- (ACBT) / Active cycle breath technique
- Conditions
- Respiratory Complication, Cardiac Disease
- Keywords
- Respiratory function, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to improve pulmonary function impairment is associated with a reduction in chest expansion, lung volume, pain perception and an impairment of the Post cardiac surgery patient's ability to cough effectively. The technique of active cycle breathing consisted of three parts to the ACBT, which are:
- breathing control
- deep breaths
- huff or cough
Detailed description
This study aims to explore the effect of Active Cycle Breathing Technique on Respiratory Parameters and Pain in Early Post Cardiac Surgery Patients
Research hypothesis:
-Post cardiac surgery patients who practice active breathing techniques exhibit an improvement in clinical outcomes compared to those who do not practice.
Research design:
A randomized control trial research design will be utilized to conduct this study.
Study Setting:
This study was carried out at the cardiac ICUs. A sample of 120 cardiac patients will be assigned in the current study from the previously mentioned settings.
The patients will be allocated into two equal groups, each with 60 patients. The control group will be composed of 60 patients who were managed by routine cardiac care The study group will consist of 60 patients who were exposed to an active cycle of breathing techniques
Inclusion criteria:
- Adult patients of both genders.
- After extubating for at least 6 hours
- Hemodynamic stable patients
- Able to communicate. Exclusion criteria: Patient with complication postoperative surgery Patient's demographic characteristics as patient's code, age, gender, marital status, education, and occupation.
Study group: managed by the use of active cycle breathing techniques combined with routine physiotherapy.
- Each session of the active cycle breathing technique lasted for 10 to 20 minutes.
- The active cycle breathing technique was carried out for three days post extubating four sessions done daily.
Implementation of active cycle breathing technique
- Explain the steps of ACBT to the patient.
- The patient was placed in a semi-sitting position with her or his back straight, and instructions were given to the patient to do the following steps: 1 . Breathing control phase
- Hold the spirometer straight.
- Exhale, then seal your lips around the mouthpiece and inhale slowly and deeply into your mouth.
- The piston in the incentive spirometer's transparent chamber will rise when you inhale deeply.
- Hold your breath for 3 to 5 seconds after taking a deep breath.
- Remove the mouthpiece and slowly exhale. For a few seconds, until the piston descends to the bottom of the chamber, relax and breathe normally.
- To regain control of their breathing, the patient was told to do lengthy, slow expirations between 5 and 7 times. 2 . Thoracic expansion exercises The patient was instructed to relax your upper chest.
- The patient was instructed to breathe slowly and deeply through the nose without using the accessory muscle.
- The patient was instructed to hold their breath initially for 3 to 4 seconds and gradually increase it to the maximum time.
Don't force the breath out; instead, softly exhale through pursed lips until your lungs are empty.
- Repeat the previous steps from 3to4 times. 3- Forced expiration technique (huffing)
- Patient was instructed to support the incision site by using a chest binder or keeping your hands over your incision.
- Cough twice as many times as they huffed two to three times.
- This step was repeated a minimum of two times and a maximum of three times in one session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The total group will be divided into two group: control and intervention group Control group receives standard care in the unit Intervention group receives active cycle breathing techniques
| Arm | Type | Receives |
|---|---|---|
| Active cycle breathing technique | Experimental | Procedure: Active cycle breathing techniqueBreathing control phase Thoracic expansion exercises Forced expiration technique (huffing) |
| Control group | Placebo comparator | Procedure: Routine carePatient who receives the routine care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients of both genders.
- After extubating for at least 6 hours post operation.
- Hemodynamic stable patients
- Able to communicate.
Key exclusion criteria (1 listed)
- Instability of patient's medical condition or hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active cycle breathing techniqueThe ACBT was included if it was described as containing three essential components: 1) breathing control, 2) forced expiration technique and 3) thoracic expansion exercises. The technique may also include postural drainage (PD) or percussion/shaking. | Procedure or surgery | Active cycle breathing technique |
| Routine careRoutine care delivers after extubating such as percussion or chest physiotherapy | Procedure or surgery | Control group |
Primary outcome
Respiratory parameters
Time frame: Three observation days
change in respiratory rate
Pain perception
Time frame: Three observation days
Using visual analogue scale score 0 mean no pain while score 10 means sever pain
Dyspnea-related kinesiophobia
Time frame: preoperative, three observation days, and day of discharge
comprises 11 items include five items dyspnea and six items for fear of activity dimension and each item is rated from "strongly disagree" (score = 1) to "strongly agree" (score = 5) for a total score between 11 and 55.
2 secondary outcomes
Deterioration in clinical parameters such as vital signs
Time frame: Three observation days
ICU and hospital stay
Time frame: three observation days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 22100537Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
- Background: PubMed 27378490Mckoy NA, Wilson LM, Saldanha IJ, Odelola OA, Robinson KA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2016 Jul 5;7(7):CD007862. doi: 10.1002/14651858.CD007862.pub4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle breathing technique and Routine care in people with Respiratory Complication and Cardiac Disease, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory parameters (time frame: Three observation days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06521346, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.