The Effect of Slow Breathing Exercise Applied to Patients on Pulse, Blood Pressure and Quality of Life

NCT06098222 | Unknown

• 2 other identifiers: TUBITAKprojectnumbered223S237223S237
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent Primary Percutaneous Coronary Intervention (PCI) I after the diagnosis of ST Elevation Myocardial Infarction (STEMI). Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria. In this study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks. Data will be collected using the "Patient Information Form", "MacNew Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.

Conditions

Slow Breathing; Acute Myocardial Infarction

Keywords

Blood Pressure; Pulse; Percutaneous Coronary Intervention; Quality of Life; Slow Breathing Exercise

Outcome Measures

Primary Outcomes (4)

• Slow breathing exercise changes the pulse rate

  The pulse rate in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly (p\<0.05) lower than the control group. A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure pulse values. Volunteers will be asked to take measurements twice a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise. The experimental group's heart rate will be measured at home on weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise. Patients will be given a patient follow up form to record data.

  2 months

• Slow breathing exercise changes systolic blood pressure

  Systolic blood pressure in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly lower (p\<0.05) than the control group. A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure blood pressure values. Volunteers will be asked to take measurements two days a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise. The experimental group's blood pressure measurements will be measured at home during the weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise. Patients will be given a patient follow up form to record data.

  2 months

• Slow breathing exercise changes diastolic blood pressure

  Diastolic blood pressure in the experimental group that applied slow breathing exercises after Percutaneous Coronary Intervention is expected to be statistically significantly lower (p\<0.05) than the control group. A calibrated portable digital upper arm blood pressure monitor purchased within the scope of the TUBITAK project will be delivered to the patient to measure blood pressure values. Volunteers will be asked to take measurements two days a week, one weekday and one weekend, in the morning, after a very light breakfast or 2 to 4 hours after a meal, and after at least five minutes of rest and breathing exercise. The experimental group's blood pressure measurements will be measured at home during the weekdays, independently of the breathing exercise, and on the weekends, before and after the breathing exercise. Patients will be given a patient follow up form to record data.

  2 months

• Mac New Heart Disease Health Related Quality of Life Scale

  Mac New Heart Disease Health Related Quality of Life Questionnaire is a scale developed by Oldridge et al. in 1991 to determine the quality of life of patients after Myocardial Infarction. This scale is designed to evaluate how physical, emotional, social functions and daily activities are affected by Coronary Artery Disease over a two week period. This scale consists of three subscales and 27 items: physical limitation scale (n=13), emotional function scale (n=14) and social function scale (n=13). Scores range from 1 to 7 on average. A low score indicates worse quality of life, a high score indicates better quality of life. Some of the items contain more than one sub-dimension. Subscale scores are calculated by averaging the answers to questions in each subscale, and considering possible scores ranging from 1 to 7, higher scores indicate a better quality of life. Cronbach Alpha Value is \> 0.93. Written permission was obtained for the use of the scale.

  2 months

Secondary Outcomes (1)

• Satisfaction of Breathing Exercise

  2 months

Study Arms (2)

Slow breathing exercise training

EXPERIMENTAL

Slow breathing exercise training will be given to patients in the experimental group. After discharge, patients will be asked to do slow breathing exercises twice a day for 10 minutes every day for eight weeks. Daily and/or weekly online, weekday, weekend, daytime, evening, video phone calls will be made with patients who are discharged at the end of the training to practice the slow breathing exercise every day according to the patients' demand. It will be provided that breathing exercises will be performed together with a video call in the form of a conference call. Patients will be asked to take measurements a total of two days a week, one day on weekdays and one day on weekends, in the morning, after a light breakfast, at least five minutes of rest and breathing exercises. Pulse and blood pressure measurements at home on weekdays will be asked to be measured Decouply from breathing exercise, and on weekends before and after breathing exercise.

Behavioral: Slow breathing exercise training

Control group

NO INTERVENTION

In the control group, patients will be shown and told self-blood pressure and pulse measurement at home at discharge. A reminder text message will be sent to the mobile phones of patients for blood pressure and pulse measurement at home. The control group will also be asked to perform their own blood pressure and pulse monitoring at home and record a Self-Monitoring Form (for the Control group).During home follow-up, patients will be sent reminder text messages to their mobile phones two days a week. According to the request of patients, daily and/or weekly online, weekdays, weekends, daytime, evening, phone calls will be made to measure pulse and blood pressure values two days a week.

Interventions

Slow breathing exercise training BEHAVIORAL

Slow breathing exercise training will be given by the researcher in a single one-hour session in the meeting room of the unit 24 hours after the PCI and/or the next day. After a 20-minute silent rest in the training, patients will be asked to breathe slowly through the nostrils for 4 seconds and slowly exhale through the mouth for 6 seconds to reach 6-8 breaths/min. The patient will rest for 5 seconds after every 6 slow breaths. During the training period, a stopwatch will be used by observing the patient's chest and abdominal movements in order to determine whether the patients have reached the required respiratory rate.

Slow breathing exercise training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young adult patients between the ages of 18-65,
• Patients who have not received fibrinolytic therapy before or simultaneously with Percutaneous Coronary Intervention (PCI) procedure,
• Patients who have passed 24 hours after the PCI procedure,
• Patients with a pulse \> 60/min (whether or not beta blockers are used after PCI),
• Patients without rhythm problems,
• Patients with hypertension (systolic blood pressure 140-179 mmHg, diastolic blood pressure 90-109 mmHg), (whether or not they use antihypertensive and beta blocker drugs),
• Patients without a diagnosis of mental or psychiatric disease,
• Patients who have the materials to watch the breathing exercise video,
• Patients who can receive reminder messages and make video calls (with devices such as a smartphone, computer, tablet, etc.),
• Patients with a portable blood pressure monitor suitable for pulse and blood pressure measurement during home monitoring (the necessary equipment will be provided within the scope of the TUBITAK project),
• Patients without hearing or visual impairment,
• Patients who can read and write
• Patients who can communicate,
• Patients without language problems,
• Patients who volunteer and indicate this verbally and in writing

You may not qualify if:

• Patients with elective/appointed appointments for whom PCI is planned in advance,
• Patients whose PCI procedure failed,
• Patients who underwent only thrombus aspiration and balloon angioplasty during the PCI procedure,
• Patients who have previously undergone PCI and at least one year has not passed since,
• Patients who do not comply with planned interventions,
• Patients who do not volunteer to participate in the study,
• Patients with physical limitations and respiratory distress who cannot do breathing exercises,
• Patients with rhythm problems,
• Patients with diseases that can increase heart rate (anemia, hyperthyroidism, hyperthermia, infection),
• Patients who are morbidly obese (Body Mass Index \> 40 kg/m2),
• Patients with hearing impairment,
• Patients with mental disabilities or perception problems,
• Patients who have previously received breathing therapy training will not be included in the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul Provincial Directorate of Health Koşuyolu High Specialization Education and Research Hospital

Istanbul, 34852, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Celik M, Celik S. Effects of Slow Breathing Exercises on Heart Rate, Blood Pressure, and Quality of Life in Patients Undergoing Primary Percutaneous Coronary Intervention: Randomized Controlled Trial. Appl Psychophysiol Biofeedback. 2026 Feb 2. doi: 10.1007/s10484-026-09767-9. Online ahead of print.

  PMID: 41627721 DERIVED

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melike CELIK, Lecturer

  Marmara University

  PRINCIPAL INVESTIGATOR

• Selda CELIK, Assoc.Prof.

  University of Health science

  STUDY DIRECTOR

• MELİKE CELİK, Lecturer

  905321562205

  STUDY CHAIR

Central Study Contacts

Melike CELIK, Lecturer

CONTACT

905321562205; melike.celik@marmara.edu.tr

Selda CELIK, Assoc.Prof.

CONTACT

905332253856; selda.celik@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 24, 2023
• Study Start: October 23, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)