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

NCT ID: NCT06460740

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-07-01

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.

Conditions

Post-cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

4-7-8 breathing technique

4-7-8 breathing technique and stationary cycling

Group Type: EXPERIMENTAL

4-7-8 breathing technique

Intervention Type: OTHER

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.

Stationary cycling

Stationary Cycling

Group Type: ACTIVE_COMPARATOR

Stationary Cycling

Intervention Type: OTHER

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

Interventions

4-7-8 breathing technique

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.

Intervention Type: OTHER

Stationary Cycling

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

Intervention Type: OTHER

Other Intervention Names

Generalized Active ROM; Generalized Active ROM

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qurat ul-Ain, MSCPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Medicare Cardiac and General Hospital

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Facility Contacts

Qurat ul-Ain, MSCPPT

Role: primary

qurat.ain@riphah.edu.pk

+92-031-21707719

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Other Identifiers

REC/47039 Samrah Mahmood

Identifier Type: -

Identifier Source: org_study_id