Clinical trial NCT06460740: Comb Effect of 4-7-8 Breathing Technique and Stationary Cycle on PP, QOL and Dyspnea in Post CABG Patients.
Official title: Combined Effects of 4-7-8 Breathing Technique and Stationary Cycle on Physical Performance, Quality of Life and Dyspnea in Post CABG Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-cardiac Surgery
Keywords: 4-7-8 breathing technique
stationary cycling
Post CABG
physical performance
quality of life
Dyspnea
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Physical Performance 6MWT
timeFrame: 4th week
Secondary outcomes:
measure: SF-36 Quality of Life Questionnaire version 2.0
timeFrame: 4th week
measure: Modified Borg Dyspnea Scale
timeFrame: 4th week
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Medicare Cardiac and General Hospital
state: Sindh
Study officials:
affiliation: Riphah International University
name: Qurat ul-Ain, MSCPPT
role: PRINCIPAL_INVESTIGATOR
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