NCT06460740

Brief Summary

To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 11, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

4-7-8 breathing techniquestationary cyclingPost CABGphysical performancequality of lifeDyspnea

Outcome Measures

Primary Outcomes (1)

  • Physical Performance 6MWT

    Changes from baseline The 6-minute walk test (6MWT) was developed by American Thoracic society and was officially introduced in 2002, coming along with a comprehensive guideline. The 6MWT is an easy, safe, reliable and simple cardiopulmonary sub maximal functional testing modality, used to assess functional capacity and to evaluate the cardiac and pulmonary rehabilitation treatment or intervention. (16) The individuals were requested to walk as far-off as they are able to on a smooth area for about 6 minutes. Individuals were permitted to take a rest or stop from walking if it was required then continue again as quick as they can. The distance covered by individuals for this test was measured in meters.

    4th week

Secondary Outcomes (2)

  • SF-36 Quality of Life Questionnaire version 2.0

    4th week

  • Modified Borg Dyspnea Scale

    4th week

Study Arms (2)

4-7-8 breathing technique

EXPERIMENTAL

4-7-8 breathing technique and stationary cycling

Other: 4-7-8 breathing technique

Stationary cycling

ACTIVE COMPARATOR

Stationary Cycling

Other: Stationary Cycling

Interventions

Treatment will be given 18 exercise sessions per month (four to five times per week). The patient at first will be directed to sit or lie down, in which manner they feel sense of comfort. Then they are asked to exhale completely through mouth emptying their lungs. Then closing their lips and inhaling silently through nose while counting on the count of 4 seconds, holding their breath for a count of 7 seconds and exhale slowly through semi-closed lips making a Whoosh sound for a count of 8 seconds. Inhale, hold breath, and exhale ratio of 4:7:8. In aerobic protocol, F (frequency) subjects will receive training up to 18 exercise sessions per month (four to five times per week). I (intensity) subjects will receive training up to intensity of 70 to 75 %, T \& T (Time and Type) subjects will receive training up to 20 minutes of bicycling.

Also known as: Generalized Active ROM
4-7-8 breathing technique

In aerobic protocol, F (frequency) subjects will receive training up to 18 exercise sessions per month (four to five times per week). I (intensity) subjects will receive training up to intensity of 70 to 75 %, T \& T (Time and Type) subjects will receive training up to 20 minutes of bicycling

Also known as: Generalized Active ROM
Stationary cycling

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent a successful CABG (no complications during surgery
  • and/or in the following weeks)
  • Female and male whose age between 40 to 70 years of age
  • Phase II cardiac rehab patients
  • Patients who were extubated and hemodynamically stable
  • Patients with stable chronic heart failure.
  • Patients had no arrhythmias
  • Patients who had ability to read and write
  • Patients who voluntarily participated in the study.

You may not qualify if:

  • Ventricular Septal defect repair.
  • Patients have limitation of motion that prevents them from performing physical activities such as walking for 6 minute.
  • Patients who had undergone previous cardiac surgery.
  • Severe renal dysfunction requiring dialysis.
  • Altered level of consciousness.
  • A history of musculoskeletal problems
  • Having an orthopedic problem that prevents the use of lower and upper extremity bikes.
  • Cancer patients receiving radiotherapy and chemotherapy.
  • Clinical diagnosis of uncontrolled Diabetes Mellitus and Hypertension.
  • Physical Discomfort at any stage of the study and/or any reaction to the tests (nausea, dizziness, discomfort, feeling faint, tachycardia, excessive sweating), and if they failed to attend the scheduled sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicare Cardiac and General Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (16)

  • Wahdan Abd El-Aziz W, Attia Kandee N, Elsayed Mansour H. The Effect of Early SixMinute Walking Test Post-Coronary Artery Bypass Graft on Walking Tolerance and Physiological Parameters. Egyptian Journal of Health Care. 2020;11(3):784-94.

    BACKGROUND
  • Ambina K, Shalimol U, Anjana A. Quality of Life among Post CABG Patients. Prof(Dr) RK Sharma. 2020;20(4):41535.

    BACKGROUND
  • Abdelaziz Mohammed F, Shoeib Ali F. Effect of Early Ambulation Program on Selected Outcomes among Patients Undergoing Cardiac Surgery. Egyptian Journal of Health Care. 2022;13(4):888-904.

    BACKGROUND
  • Schulte B, Nieborak L, Leclercq F, Villafane JH, Sanchez Romero EA, Corbellini C. The Comparison of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training after Coronary Artery Bypass Graft: A Systematic Review of Recent Studies. J Cardiovasc Dev Dis. 2022 Sep 28;9(10):328. doi: 10.3390/jcdd9100328.

    PMID: 36286280BACKGROUND
  • Kansara P, Patel S. Effect of Post Operative Physiotherapy in Patients with CABG to Improve Cardiovascular Endurance-A Randomised Controlled Trial.

    BACKGROUND
  • Yükselmiş Ö. The Effect of Cycling and Arm Ergometer Exercises on Physical and Psychosocial Functions: Application in Patients Undergoing Coronary Artery Bypass Surgery. Open Journal of Therapy and Rehabilitation. 2022;10(2):39-53

    BACKGROUND
  • Munir U, Umar Riaz NF, Sahar W, Tariq K. Effects of Preoperative Aerobic Training for Improving Postoperative Functional Mobility in Coronary Artery Bypass Graft Patients. 2023.

    BACKGROUND
  • Naqvi M, Khan MS, Perwaiz S, Ibrahim Q, Khan MW, Khan TY. Comparative analysis on the efficacy of aerobic capacity in cardiac rehabilitation obese and non-obese phase ii patient. International Journal of Physiotherapy. 2019:64-9.

    BACKGROUND
  • Vierra J, Boonla O, Prasertsri P. Effects of sleep deprivation and 4-7-8 breathing control on heart rate variability, blood pressure, blood glucose, and endothelial function in healthy young adults. Physiol Rep. 2022 Jul;10(13):e15389. doi: 10.14814/phy2.15389.

    PMID: 35822447BACKGROUND
  • Krasavina T, Zaborova V, Lazareva I, Yurku K, Putilo V, Gameeva V, et al. Rehabilitation of patients with coronary heart disease after coronary artery bypass grafting at the stationary stage. Journal of IMAB-Annual Proceeding Scientific Papers. 2023;29(2):4980-3.

    BACKGROUND
  • Hamed LA, Elsayed SM. Effect of Deep Breathing Exercises on Pain after Cardiac Catheterization: A Randomized Controlled Trial.

    BACKGROUND
  • Gambassi BB, Almeida FJF, Almeida AEAF, Ribeiro DAF, Gomes RSA, Chaves LFC, Sousa TMDS, Nina VJDS. Acute Response to Aerobic Exercise on Autonomic Cardiac Control of Patients in Phase III of a Cardiovascular Rehabilitation Program Following Coronary Artery Bypass Grafting. Braz J Cardiovasc Surg. 2019 Jun 1;34(3):305-310. doi: 10.21470/1678-9741-2019-0030.

    PMID: 31310469BACKGROUND
  • Sheraz S, Ayub H, Ferraro FV, Razzaq A, Malik AN. Clinically Meaningful Change in 6 Minute Walking Test and the Incremental Shuttle Walking Test following Coronary Artery Bypass Graft Surgery. Int J Environ Res Public Health. 2022 Nov 1;19(21):14270. doi: 10.3390/ijerph192114270.

    PMID: 36361150BACKGROUND
  • Moreira JMA, Grilo EN. Quality of life after coronary artery bypass graft surgery - results of cardiac rehabilitation programme. J Exerc Rehabil. 2019 Oct 28;15(5):715-722. doi: 10.12965/jer.1938444.222. eCollection 2019 Oct.

    PMID: 31723562BACKGROUND
  • Ghorbani A, Hajizadeh F, Sheykhi MR, Mohammad Poor Asl A. The Effects of Deep-Breathing Exercises on Postoperative Sleep Duration and Quality in Patients Undergoing Coronary Artery Bypass Graft (CABG): a Randomized Clinical Trial. J Caring Sci. 2018 Dec 1;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.

    PMID: 31915624BACKGROUND
  • Radi B, Ambari AM, Dwiputra B, Intan RE, Triangto K, Santoso A, Setianto B. Determinants and Prediction Equations of Six-Minute Walk Test Distance Immediately After Cardiac Surgery. Front Cardiovasc Med. 2021 Aug 19;8:685673. doi: 10.3389/fcvm.2021.685673. eCollection 2021.

    PMID: 34490363BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Qurat ul-Ain, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only the patients will be blind its a single blind study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

July 1, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations