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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

Protocol summary

Study aim
Effects of aerobic-breathing training on sleep quality,fatigue,functional capacity (VO2 peak), rest and peak hemodynamic indices in patients with mitral valve prolapse.
Design
Clinical trial with control group, parallel-group trial, single-blinded, randomized, phase 2 clinical trial on 30 patients. Opaque envelopes will be used for randomization.
Settings and conduct
Thirty women with MVP will be selected from Tabriz and randomly assigned to two experimental groups (aerobic plus breathing exercises) and one control group. The outcome assessor and statistical analyst will be blinded to group assignments. Variables will be measured at two-time points: before and after the 12-week exercise protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- A history of more than three years of mitral valve prolapse, 2-mild to moderate Mitral regurgitation, 3- normal ventricular function, 4- no history of stroke, panic attacks, hypertension, mental or cognitive disorders, or valve replacement or repair surgery Exclusion criteria: Other major cardiovascular diseases, respiratory diseases, diabetes, and pregnancy.
Intervention groups
Intervention group: Participated in 12 weeks of aerobics combined with breathing exercises, 3 weekly sessions for 45 to 70 minutes each at a moderate intensity. Control group: will Continue with their usual daily activities
Main outcome variables
Sleep quality, fatigue, functional capacity (VO2peak), resting and peak blood pressure, resting and peak heart rate, resting and peak RPP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160523028028N4
Registration date: 2025-01-06, 1403/10/17
Registration timing: prospective

Last update: 2025-01-06, 1403/10/17
Update count: 0
Registration date
2025-01-06, 1403/10/17
Registrant information
Name
Azam Zarneshan
Name of organization / entity
Azarbaijan Shahid Madani University
Country
Iran (Islamic Republic of)
Phone
+98 41 3432 7505
Email address
zarneshan@azaruniv.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-02, 1403/12/12
Expected recruitment end date
2025-05-05, 1404/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The Effect of of Aerobic with Breathing Exercises on Physical-Psychological Symptoms in Patients with Mitral Valve Prolapse
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of mitral valve prolapse for over three years Mild to moderate mitral regurgitation Normal ventricular function
Exclusion criteria:
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.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azarbaijan shahidmadani university
Street address
Varzesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5541916777
Approval date
2024-07-22, 1403/05/01
Ethics committee reference number
IR.AZARUNIV.REC.1403.005

Health conditions studied

1

Description of health condition studied
Mitral Valve Prolapse
ICD-10 code
I34.1
ICD-10 code description
Nonrheumatic mitral (valve) prolapse

Primary outcomes

1

Description
Sleep quality
Timepoint
Before and after 12 weeks of training protocol
Method of measurement
Petersburg Sleep Questionnaire (PSQI)

2

Description
Fatigue
Timepoint
Before and after 12 weeks of training protocol
Method of measurement
Daily fatigue questionnaire (Multidimensional Fatigue Inventory)

3

Description
Peak VO2
Timepoint
Before and after 12 weeks of training protocol
Method of measurement
6-minute walk test(6MWT)

4

Description
Resting systolic and diastolic blood pressure
Timepoint
Before and after 12 weeks of training protocol
Method of measurement
Omron M3 digital blood pressure monitor

5

Description
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

6

Description
Rest Heart rate
Timepoint
Before and after 12 weeks of training protocol
Method of measurement
Omron M3 digital blood pressure monitor

7

Description
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

8

Description
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)

9

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
Control group: will Continue with their usual daily activities
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiovascular clinic
Full name of responsible person
Babak Zanjani
Street address
Farid Building, Namaz Square
City
Tabriz
Province
East Azarbaijan
Postal code
55419167777
Phone
+98 910 283 2540
Email
Dr.babak.znj@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Azam Zarneshan
Street address
Varzesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5375171379
Phone
+98 41 3432 7505
Email
zarneshan@azaruniv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azarbaijan Shahid Madani University
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Azam Zarneshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular and respiratory exercise physiology
Street address
Varzesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5541916777
Phone
+98 41 3145 2407
Email
zarneshan@azaruniv.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Azam Zarneshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular and respiratory exercise physiology
Street address
Varzesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5541916777
Phone
+98 41 3145 2407
Email
zarneshan@azaruniv.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Azam Zarneshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular and respiratory exercise physiology
Street address
Varzesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5541916777
Phone
+98 41 3145 2407
Email
zarneshan@azaruniv.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data collection will be done by the researchers and information about the main outcomes of the study will be published.
When the data will become available and for how long
Access to the data will be possible immediately after the results are printed.
To whom data/document is available
The general public, athletic trainers, MVP patients, and researchers
Under which criteria data/document could be used
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.
From where data/document is obtainable
Dr. Azam Zarneshan email: zarneshan@azaruniv.ac.ir
What processes are involved for a request to access data/document
via email to the corresponding author: Dr. Azam Zarnashan zarneshan@azaruniv.ac.ir
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