NCT04307316

Brief Summary

This study is designed to determine the effects of Active cycle of breathing technique (ACBT) on cardiopulmonary parameters of post CABG patients. A randomized control trial was conducted with a sample size of 40 post CABG patients. Non probability Convenience Sampling Technique was used to collect sample and randomization was done through sealed envelope method to allocate participants to the groups. Patients in experimental group did ACBT along with the conventional treatment protocol that was performed in the control group. Subjects completed the exercise protocol of 5 days. Both male and female post CABG patients of age 30-65 years who were vitally stable were included in study. Data was analyzed on Statistical Package for the Social Sciences (SPSS) version 21. Normality was assessed through shapiro wilk test. Parametric tests were applied on normally distributed variables and non parametric tests were applied for the non normally distributed data. Confidence interval was kept at 95% and p value \<0.05 was considered significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

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

Study Start

First participant enrolled

August 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 6, 2020

Last Update Submit

March 12, 2020

Conditions

Keywords

Active cycle of breathing techniqueChest expansionCoronary artery bypass graft surgeryFEV1FVCPEFR

Outcome Measures

Primary Outcomes (5)

  • Forced Expiratory Volume in 1 second (FEV1)

    Forced Expiratory Volume in 1 second (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.

    After 5days

  • Forced vital capacity (FVC)

    Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.

    After 5days

  • FEV1/FVC

    FEV1/FVC measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).

    After 5days

  • Peak expiratory flow rate (PEFR)

    Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.

    After 5days

  • Chest expansion

    Chest expansion at xiphoid level measured by finding the difference in measurements during inhalation and exhalation.

    After 5 days

Secondary Outcomes (4)

  • Heart rate

    After 5days

  • Respiratory rate

    After 5 days

  • Systolic and diastolic blood pressure

    After 5days

  • Oxygen Saturation (SPO2)

    After 5days

Study Arms (2)

ACBT group

EXPERIMENTAL

Active cycle breathing technique

Other: ACBT group

Conventional treatment group

ACTIVE COMPARATOR

Conventional treatment group

Other: Conventional Physical therapy

Interventions

ACBT: Breathing control 3 to 4 Thoracic Expansion Exercise A: 3 seconds hold B: Chest clapping C: Chest vibration Forced Expiratory Technique Breathing control A: 3 seconds hold B: Chest clapping C: Chest vibration 3 to 4 Thoracic Expansion Exercise Breathing control 1-2 Huff combine with breathing control Huff and cough Chest Physical Therapy Early mobilization

ACBT group

Chest percussion, deep breathing, Huff and cough. Early mobilization

Conventional treatment group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vitally stable post CABG patients

You may not qualify if:

  • Hemodynamically unstable patients
  • Patient after re-opening of sternum.
  • Infected patients
  • Patients who cannot speak Urdu, Punjabi or English language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (9)

  • Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/

    PMID: 29939613BACKGROUND
  • Freitas ER, Soares BG, Cardoso JR, Atallah AN. Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD004466. doi: 10.1002/14651858.CD004466.pub3.

    PMID: 22972072BACKGROUND
  • Hue B, Pelhate M, Callec JJ, Chanelet J. Synaptic transmission in the sixth ganglion of the cockroach: action of 4-aminopyridine. J Exp Biol. 1976 Dec;65(3):517-27. doi: 10.1242/jeb.65.3.517.

    PMID: 190333BACKGROUND
  • Zanini M, Nery RM, de Lima JB, Buhler RP, da Silveira AD, Stein R. Effects of Different Rehabilitation Protocols in Inpatient Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):E19-E25. doi: 10.1097/HCR.0000000000000431.

    PMID: 31343586BACKGROUND
  • Uzmezoglu B, Altiay G, Ozdemir L, Tuna H, Sut N. The Efficacy of Flutter(R) and Active Cycle of Breathing Techniques in Patients with Bronchiectasis: A Prospective, Randomized, Comparative Study. Turk Thorac J. 2018 Jul;19(3):103-109. doi: 10.5152/TurkThoracJ.2018.17050. Epub 2018 Jun 12.

    PMID: 30083399BACKGROUND
  • 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
  • Thybo Karanfil EO, Moller AM. Preoperative inspiratory muscle training prevents pulmonary complications after cardiac surgery - a systematic review. Dan Med J. 2018 Mar;65(3):A5450.

    PMID: 29510803BACKGROUND
  • Renault JA, Costa-Val R, Rosseti MB, Houri Neto M. Comparison between deep breathing exercises and incentive spirometry after CABG surgery. Rev Bras Cir Cardiovasc. 2009 Apr-Jun;24(2):165-72. doi: 10.1590/s0102-76382009000200012.

    PMID: 19768295BACKGROUND
  • Filbay SR, Hayes K, Holland AE. Physiotherapy for patients following coronary artery bypass graft (CABG) surgery: limited uptake of evidence into practice. Physiother Theory Pract. 2012 Apr;28(3):178-87. doi: 10.3109/09593985.2011.582231. Epub 2011 Aug 8.

    PMID: 21823991BACKGROUND

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 13, 2020

Study Start

August 30, 2018

Primary Completion

February 20, 2019

Study Completion

December 20, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations