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

Combined Effects of 4-7-8 Breathing Technique and Stationary Cycle on Physical Performance, Quality of Life and Dyspnea in Post CABG Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06460740
Enrollment
58
Registered
2024-06-14
Start date
2024-01-01
Completion date
2024-07-01
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-cardiac Surgery

Keywords

4-7-8 breathing technique, stationary cycling, Post CABG, physical performance, quality of life, Dyspnea

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.

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.

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Only the patients will be blind its a single blind study

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical Performance 6MWT4th weekChanges 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

MeasureTime frameDescription
SF-36 Quality of Life Questionnaire version 2.04th weekChanges 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 Scale4th weekChanges 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.

Countries

Pakistan

Contacts

Primary ContactImran Amjad
imran.amjad@riphah.edu.pk03324390125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026