NCT06476756

Brief Summary

This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

March 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 12, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

Buteyko

Outcome Measures

Primary Outcomes (2)

  • Borg dyspnea scale

    The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.

    base line and 4 week

  • BREATHLESSNESS, COUGH AND SPUTUM SCALE (BCSS)

    The BCSS is a three-item patient-reported questionnaire that rates sputum, cough, and dyspnea . This instrument can identify a disease aggravation with sensitivity and specificity.

    4 weeks

Study Arms (2)

ACTIVE CYCLE OF BREATHING TECHNIQUE

EXPERIMENTAL

Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1.

Other: ACTIVE CYCLE OF BREATHING TECHNIQUE

Buteyko techniques

EXPERIMENTAL

Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.

Other: Buteyko techniques

Interventions

Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1.

ACTIVE CYCLE OF BREATHING TECHNIQUE

Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.

Buteyko techniques

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40-60 years
  • Patient underwent cardiac surgery for first time
  • Having speaking, hearing, cognitive ability
  • Both genders ( Male and female)
  • On mechanical ventilation for less than 24h after surgery

You may not qualify if:

  • Hemodynamic ally unstable patients
  • Patients with reopening of sternum
  • Infection patients
  • Renal failure
  • Arrhythmia
  • Patient on mechanical ventilator
  • Cancer
  • Tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi teaching hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • Cappello IA, Candelari M, Pannone L, Monaco C, Bori E, Talevi G, Ramak R, La Meir M, Gharaviri A, Chierchia GB, Innocenti B, de Asmundis C. 3D Printed Surgical Guide for Coronary Artery Bypass Graft: Workflow from Computed Tomography to Prototype. Bioengineering (Basel). 2022 Apr 19;9(5):179. doi: 10.3390/bioengineering9050179.

    PMID: 35621457BACKGROUND
  • Frak W, Wojtasinska A, Lisinska W, Mlynarska E, Franczyk B, Rysz J. Pathophysiology of Cardiovascular Diseases: New Insights into Molecular Mechanisms of Atherosclerosis, Arterial Hypertension, and Coronary Artery Disease. Biomedicines. 2022 Aug 10;10(8):1938. doi: 10.3390/biomedicines10081938.

    PMID: 36009488BACKGROUND
  • Kamiya K, Takei M, Nagai T, Miyoshi T, Ito H, Fukumoto Y, Obara H, Kakuma T, Sakuma I, Daida H, Iimuro S, Shimokawa H, Kimura T, Nagai R, Anzai T. Association between Non-Lipid Residual Risk Factors and Cardiovascular Events in Patients with Stable Coronary Artery Disease Treated with Pitavastatin: An Observation from the REAL-CAD Study. J Atheroscler Thromb. 2024 Jan 1;31(1):61-80. doi: 10.5551/jat.64304. Epub 2023 Aug 11.

    PMID: 37574272BACKGROUND

Study Officials

  • Sidra Faisal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1. Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 26, 2024

Study Start

March 10, 2024

Primary Completion

July 15, 2024

Study Completion

August 20, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations