NCT06521346

Brief 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. The technique of active cycle breathing consisted of three parts to the ACBT, which are:

  • breathing control
  • deep breaths
  • huff or cough

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

July 19, 2024

Last Update Submit

December 19, 2025

Conditions

Keywords

Respiratory functionCardiac surgery

Outcome Measures

Primary Outcomes (3)

  • Respiratory parameters

    change in respiratory rate

    Three observation days

  • Pain perception

    Using visual analogue scale score 0 mean no pain while score 10 means sever pain

    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.

    preoperative, three observation days, and day of discharge

Secondary Outcomes (2)

  • Deterioration in clinical parameters such as vital signs

    Three observation days

  • ICU and hospital stay

    three observation days

Study Arms (2)

Active cycle breathing technique

EXPERIMENTAL

Breathing control phase Thoracic expansion exercises Forced expiration technique (huffing)

Procedure: Active cycle breathing technique

Control group

PLACEBO COMPARATOR

Patient who receives the routine care

Procedure: Routine care

Interventions

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.

Active cycle breathing technique
Routine carePROCEDURE

Routine care delivers after extubating such as percussion or chest physiotherapy

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients of both genders.
  • After extubating for at least 6 hours post operation.
  • Hemodynamic stable patients
  • Able to communicate.

You may not qualify if:

  • Instability of patient's medical condition or hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of nursing Damanhour university

Damanhūr, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 22100537BACKGROUND
  • Mckoy 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.

    PMID: 27378490BACKGROUND

MeSH Terms

Conditions

Heart DiseasesRespiratory Aspiration

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 25, 2024

Study Start

December 1, 2024

Primary Completion

July 1, 2025

Study Completion

October 31, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations