Comb Effect of 4-7-8 Breathing Technique and Stationary Cycle on PP, QOL and Dyspnea in Post CABG Patients.

Not Applicable

Recruiting

• Conditions: Post-cardiac Surgery
• Interventions: Other: 4-7-8 breathing technique; Other: Stationary Cycling

• Registration Number: NCT06460740
• Lead Sponsor: Riphah International University

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.

Detailed Description

Patients who meet the inclusion criteria and will be excluded from the exclusion criteria will be recruited by convenient sampling technique and will be allocated to simple randomization process. By taking a sample of 58 patients through non-probability convenience sampling and randomly assigning them into two groups, Group A and Group B for 18 exercise sessions per month (four to five times in a week), out of which group A will receive 4-7-8 breathing technique and stationary cycle (n=29). Group B will alone receive Stationary cycle (n=29). The study will be Single-blind where patients will be only blind. Pre and post treatment training outcomes of physical performance will be measured through 6-minute walk test, quality of life will be measured through Short-item 36 (SF-36) questionnaire 2.0 version and dyspnea will be measured through modified Borg scale. The data will be analyzed through SPSS version 26. Generalized active range of motion will be given to both groups.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4-7-8 breathing technique	4-7-8 breathing technique	4-7-8 breathing technique and stationary cycling
Stationary cycling	Stationary Cycling	Stationary Cycling

Primary Outcome Measures

Name	Time	Method
Physical Performance 6MWT	4th week	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.

Secondary Outcome Measures

Name	Time	Method
SF-36 Quality of Life Questionnaire version 2.0	4th week	Changes from baseline the 36 item Short-Form Survey (SF-36) is an outcome measure standardized structured questionnaire that is internationally and widely approved to evaluate the quality of life (QOL) of post CABG patients. The questionnaire was developed and used for collecting a data. The content validity was obtained from 7 experts. The questionnaire was found to be valid in assessing QOL. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Modified Borg Dyspnea Scale	4th week	Changes from baseline Borg rate of perceived exertion (RPE) or Rate of perceived dyspnea (RPD) is an outcome measuring scale was developed by Swedish researcher Gunnar Borg in the 1998, allowing the individuals to rate their level of exertion during exercise subjectively American College of Sports Medicine (ACSM), 2010. It is proposed for all patients who underwent and going through Rehabilitation and endurance training as well as used in research. It scores from 0 to 10, using numeric values to rate how much effort an activity takes or to rate the difficulty of breathing. The zero point in a scale, indicates breathing is causing no difficulty at all or no exertion at all progressing through to ten point where breathing difficult is at maximum point.

Trial Locations

Locations (1)

Medicare Cardiac and General Hospital; 🇵🇰 Karachi, Sindh, Pakistan