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Coronary Artery Bypass Graft SurgeryNCT04307316

Effects of ACBT on Pulmonary Function After CABG During Phase 1 Cardiac Rehabilitation

A study testing ACBT group and Conventional Physical therapy in people with Coronary Artery Bypass Graft Surgery, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Coronary Artery Bypass Graft Surgery
What is being tested?
ACBT group and Conventional Physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
30 Aug 2018to 20 Dec 2019
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 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Vitally stable post CABG patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

Official title: Effects of Active Cycle of Breathing Technique on Pulmonary Functions After CABG During Phase 1 Cardiac Rehabilitation

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.

Read the detailed description

Coronary artery bypass graft (CABG) is a surgery in which new routes are created around narrow and blocked coronary arteries, that allow proper flow of blood to provide oxygen and nutrients to the heart muscles. The grafts used in CABG can be a vein from lower extremity or any artery of chest. CABG is a surgery in which obstructed coronary arteries are replaced with autologous arteries and veins used as implant, which are fully or moderately congested by atherosclerotic plaque. ACBT is a method used to clear out the secretion from the chest. The purpose of ACBT treatment is to remove secretions from the chest that helps to reduce the frequency of infection, which control the additional airway impairment and worsening the lungs functions that may help in reducing the rate of progress of lung disease. After CABG surgery respiratory therapy is used rationally to inhibit the post-operative complications. Respiratory physiotherapy is routinely used in the prevention and treatment of post-operative pulmonary complications after cardiac surgery. The ultimate goal of physiotherapy in CABG patient is to improve increase lung volume, prevent atelectasis, enhance ventilation-perfusion matching, to increase sputum clearance, and decrease pain. ACBT technique can perform independently by patient with about applying manual technique. ACBT is very effective to improve oxygen saturation, control respiratory rate, and chest clearance after major surgeries. The efficiency of ACBT treatment has been checked out in stable cystic fibrosis, Chronic obstructive pulmonary disease and abdominal surgery. However, there is limited literature related to its use in patients after CABG surgery. The purpose of this research was to examine the effect of ACBT versus conventional chest physiotherapy after CABG surgery.

In 2018 a study was conducted on effect of ACBTs in post coronary artery bypass grafting patient and he concluded that ACBTs technique is a better way of treatment in coronary artery bypass grafting surgery patients. The determination of this research was to calculate the effectiveness of ACBT in CABG surgery patients. In this study total 15 patients were involved. All the patients were checked out by visual analogue scale for pain, 6-minute walk test (6MWT) for endurance and chest expansion was also measured. It concluded that chest expansion and 6MWT was improved in both groups.

ACBT is an effective technique implemented by the patient to secrete out the sputum from the main airway. The ACBT technique is combined breathing maneuvers to advance the efficiency of cough, untie and clear the secretions and increase the ventilation.

In 2016 a study was conducted observed the effects of ACBTs in post CABG surgery patients and The ACBTs treatment decrease the intensity of pulmonary impairments in post abdominal surgery.There is limited data available in support of effects of ACBTs on pulmonary functions after CABG surgery.

In 2015 a study was conducted to evaluate the effects of ACBTs on chest expansion, arterial blood gases, oxygen saturation, blood pressure, respiratory rate and other vitals in Chronic Obstructive Pulmonary disease (COPD) patients during 1st phase of cardiac rehab after CABG surgery. It concluded that ACBT are much effective than routine physiotherapy protocol in patients who have gone under coronary artery bypass grafting.

The present study is intended to observe the effects of ACBT on pulmonary function including lung volumes and capacities, chest expansion as well as the vitals of post operative CABG patients undergoing phase 1 cardiac rehabilitation.

Being tested
ACBT group, Conventional Physical therapy
Keywords
Active cycle of breathing technique, Chest expansion, Coronary artery bypass graft surgery, FEV1, FVC, PEFR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACBT groupOther

    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

  • Conventional Physical therapyOther

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

Study groups in NCT04307316
Study groupRoleWhat they receive
ACBT groupExperimentalActive cycle breathing technique
Receives: Other: ACBT group
Conventional treatment groupActive comparatorConventional treatment group
Receives: Other: Conventional Physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After 5days

  2. 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.

    Measured: After 5days

  3. 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).

    Measured: After 5days

  4. 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.

    Measured: After 5days

  5. Chest expansion

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

    Measured: After 5 days

Secondary outcomes (4)
  1. Heart rate

    Heart rate is measured as part of vitals through heart rate monitor.

    Measured: After 5days

  2. Respiratory rate

    Respiratory rate as part of vitals standing at bedside of the patients

    Measured: After 5 days

  3. Systolic and diastolic blood pressure

    Blood pressure is measured through sphygmomanometer

    Measured: After 5days

  4. Oxygen Saturation (SPO2)

    Oxygen saturation measured through pulse oximeter as part of vitals

    Measured: After 5days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start30 Aug 2018
  3. Primary completion20 Feb 2019
  4. Study completion20 Dec 2019

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307316
Sponsor's protocol ID
REC/00423 Nouman Hussain
Status last verified
Mar 2020
First submitted
6 Mar 2020
Last updated
13 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/

    PubMed 29939613
  • 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.

    PubMed 22972072
  • 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.

    PubMed 190333
  • 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.

    PubMed 31343586
  • 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.

    PubMed 30083399
  • 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 22100537
  • 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.

    PubMed 29510803
  • 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.

    PubMed 19768295
  • 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.

    PubMed 21823991

Questions about this trial

What is this clinical trial studying?

A study testing ACBT group and Conventional Physical therapy in people with Coronary Artery Bypass Graft Surgery, run by Riphah International University at 1 site in Pakistan.

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 1 inclusion and 4 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 13 Mar 2020. 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 Pakistan. 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. 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?

Forced Expiratory Volume in 1 second (FEV1) (time frame: After 5days). The study lists 5 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 NCT04307316, which also lists 9 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 13 Mar 2020.

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Clinical Trial NCT04307316 | AzTrials