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IRCT20160523028028N4 IRCT 2025-01-06 Azarbaijan Shahid Madani University The Effect of of Aerobic with Breathing Exercises on Physical-Psychological Symptoms in Patients with Mitral Valve Prolapse The Effect of Twelve Weeks of Aerobic with Breathing Exercises on Physical-Psychological Symptoms, Functional Capacity (VO2peak), and Hemodynamic Indicators in Patients with Mitral Valve Prolapse 2025-03-02 anticipated 30 Complete https://irct.ir/trial/81029 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization method will be used. Allocation concealment will be conducted by a researcher not involved in the study. Opaque, identical, sealed envelopes will be prepared, containing the type of intervention according to a randomly generated allocation sequence. The envelopes, numbered from 1 to 30, will be distributed based on the order of participants entering the study, Blinding description: The outcome assessor will be blinded to the group differences in both pre-test and post-test phases. The data analyst will also be blinded to the group differences and the groups will be entered into SPSS with codes 1 and 2. N/A Mitral Valve Prolapse. Intervention 1: Intervention group: Engage in 12 weeks of combined aerobic and breathing exercise training, three days a week for 45 to 70 minutes. The intensity of the workout will be adjusted based on heart rate and Borg's perceived exertion. According to the American College of Sports Medicine guidelines, a heart rate 20 to 30 beats above resting heart rate and a Borg's perceived exertion score of 4 to 6 (relatively mild to slightly intense) would be the target intensity. Intervention 2: Control group: will Continue with their usual daily activities. Yes - There is a plan to make this available What will be shared: Data collection will be done by the researchers and information about the main outcomes of the study will be published. When: Access to the data will be possible immediately after the results are printed. To whom: The general public, athletic trainers, MVP patients, and researchers Conditions: Reviewers of magazines and Azerbaijan Shahid Madani university are allowed to send requests to receive non-identifiable personal data or other documents. Until the publication of the results in the form of an article, it is not allowed to perform statistical analysis on the delivered data. Where to obtain: Dr. Azam Zarneshan email: zarneshan@azaruniv.ac.ir How to obtain: via email to the corresponding author: Dr. Azam Zarnashan zarneshan@azaruniv.ac.ir Comments:
public Azam Zarneshan
Varzesh Ave
Tabriz Iran (Islamic Republic of) 5541916777 +98 41 3145 2407 zarneshan@azaruniv.ac.ir Azarbaijan Shahid Madani University scientific Azam Zarneshan
Varzesh Ave
Tabriz Iran (Islamic Republic of) 5541916777 +98 41 3145 2407 zarneshan@azaruniv.ac.ir Azarbaijan Shahid Madani University Iran (Islamic Republic of) History of mitral valve prolapse for over three years Mild to moderate mitral regurgitation Normal ventricular function 20 years 50 years Female History of stroke, panic attacks, hypertension, mental or cognitive disorders, or valve replacement or repair surgery. Having other major cardiovascular diseases, respiratory diseases, and diabetes Pregnancy. I34.1 Nonrheumatic mitral (valve) prolapse Lifestyle Lifestyle Intervention group: Engage in 12 weeks of combined aerobic and breathing exercise training, three days a week for 45 to 70 minutes. The intensity of the workout will be adjusted based on heart rate and Borg's perceived exertion. According to the American College of Sports Medicine guidelines, a heart rate 20 to 30 beats above resting heart rate and a Borg's perceived exertion score of 4 to 6 (relatively mild to slightly intense) would be the target intensity. Control group: will Continue with their usual daily activities Sleep quality. Timepoint: Before and after 12 weeks of training protocol. Method of measurement: Petersburg Sleep Questionnaire (PSQI). Fatigue. Timepoint: Before and after 12 weeks of training protocol. Method of measurement: Daily fatigue questionnaire (Multidimensional Fatigue Inventory). Peak VO2. Timepoint: Before and after 12 weeks of training protocol. Method of measurement: 6-minute walk test(6MWT). Resting systolic and diastolic blood pressure. Timepoint: Before and after 12 weeks of training protocol. Method of measurement: Omron M3 digital blood pressure monitor. Peak systolic and diastolic blood pressure. Timepoint: Before and after 12 weeks of training protocol immediately after the 6MWt test. Method of measurement: Omron M3 digital blood pressure monitor. Rest Heart rate. Timepoint: Before and after 12 weeks of training protocol. Method of measurement: Omron M3 digital blood pressure monitor. Peak Heart Rate. Timepoint: Before and after 12 weeks of training protocol immediately after the 6MWt test. Method of measurement: Omron M3 digital blood pressure monitor. Rest Rate Pressure Product. Timepoint: Before and after 12 weeks of training protocol. Method of measurement: Defined by resting heart rate (RHR) multiplied by systolic blood pressure (SBP). Peak Rate Pressure Product. Timepoint: Before and after 12 weeks of training protocol immediately after the 6MWt test. Method of measurement: Defined by peak heart rate multiplied by systolic blood pressure (SBP). Azarbaijan Shahid Madani University Approved 2024-07-22 Ethics committee of Azarbaijan shahidmadani university Varzesh Ave Tabriz East Azarbaijan Iran (Islamic Republic of)