AzTrials
AzTrials

Diastolic DysfunctionNCT06945913

Effect of Swimming Exercise on Diastolic Dysfunction

A study testing Exercise in people with Diastolic Dysfunction, run by Uşak University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of the study was to determine the rehabilitative effects of 12-week variable intensity swimming exercises on the cardiovascular system in women with diastolic dysfunction. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Diastolic Dysfunction
What is being tested?
Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2025to 15 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants who met the following criteria were included in the study:
  • No echocardiographic abnormalities detected except for stage 1 diastolic dysfunction based on examinations conducted in the cardiology outpatient clinic,
  • Female gender,
  • Aged between 40 and 60 years as of the study initiation date,
  • No history of substance use, including smoking and alcohol,
  • Willingness to participate by completing the informed consent form.

Who cannot join

  • Participants who met at least one of the following conditions were excluded from the study:
  • Refusal to sign the informed consent form,
  • Failure to participate in at least one of the study measurements,
  • Inability to meet the necessary criteria for training and measurements,
  • Presence of illness or injury during training or measurements,
  • Voluntary withdrawal from the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Merve BOZ CİNCİ, Lecturer contact

+905533577475

mervebozcinci@gmail.com

Turkey (Türkiye)1 site
  • Uşak U

    Uşak, Merkez, 64100

    Uşak U Uşak Üniversitesi, +90 276 221 21 21, usak@usak.edu.tr

    Merve BOZ CİNCİ, Lecturer

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Variable Intensity Swimming Exercise On Cardiovascular Parameters And Echocardiography In Women With Diastolic Dysfunction

The aim of the study was to determine the rehabilitative effects of 12-week variable intensity swimming exercises on the cardiovascular system in women with diastolic dysfunction. Studies on how variable intensity swimming exercises contribute to the course of the disease in sedentary women with cardiovascular problems are limited. Previous studies generally consisted of studies on the effects of exercise applications on the cardiovascular system in different branches and their effects were determined.

Read the detailed description

Nowadays, combating diseases caused by sedentary lifestyle habits is among the fundamental challenges faced by humanity. With technological advancements, individuals spend most of their time in a sedentary manner, while also consuming fast-food products, which negatively affect overall health. Due to physical inactivity, obesity often develops, and in the long term, cardiovascular health is adversely impacted. As a result, physicians frequently prescribe regular exercise. To prevent the onset of such diseases, individuals engage in various sports activities. Walking, dancing, swimming, and strength training exercises are among the most preferred physical activities.

Swimming, which has become one of the most popular sports branches in Turkey compared to previous years, is gaining increasing popularity. The fact that swimming allows individuals to have an enjoyable time while exercising makes it a sought-after activity. Swimming is not only practiced professionally but is also a preferred sport among sedentary individuals aiming for a healthy lifestyle. Considering the sustainability of the learning process in this discipline, it should not be overlooked that swimming can positively contribute to instilling exercise habits in sedentary individuals.

Swimming exercises actively engage large muscle groups. Regular training of these muscle groups leads to cardiovascular adaptations that enhance exercise capacity, endurance, and skeletal muscle strength, while also preventing the development of coronary artery disease (CAD) and alleviating symptoms in individuals with pre-existing cardiovascular conditions. Swimming, which encompasses speed, strength, endurance, continuity, agility, flexibility, and aesthetic qualities, is one of the few sports disciplines that allow for the development of all these attributes over time. The improvement of physical fitness attributes is not only due to movement but also to resistance developed against water. This is because water is denser than air, requiring greater effort, thereby enhancing all physical fitness parameters in proportion to training intensity. Studies indicate that swimming exercises work the core, head, back, and abdominal muscles simultaneously, producing similar beneficial effects on the cardiovascular and skeletal systems. Moreover, swimming is among the few physical activities that ensure the harmonious development of the entire body with a significantly lower risk of injury compared to other sports disciplines. The buoyancy effect of water reduces the load on the joints, thereby minimizing musculoskeletal strain and injury risks. Given that joint disorders and related mobility limitations frequently occur due to sedentary habits in older age, swimming exercises play a crucial role in minimizing potential injuries.

To sustain vital functions, the body operates as an integrated system. All organs and tissues actively participate in these processes, ensuring continuity of life. Similarly, all motion-related activities in daily life are maintained through the extraordinary synchronization of the human body. Particularly in the case of physical activity, the load on key systems is significantly higher. For instance, while the musculoskeletal system largely assumes the responsibility for movement, the nervous system provides movement commands, and the circulatory system supplies the necessary oxygen and energy. The circulatory system, which serves as the locomotive to ensure continuity in these systems, bears crucial responsibility, especially during exercise. It delivers and transports oxygenated blood to all necessary points, a process facilitated by the superior anatomy of the heart. If the heart fails to pump blood, the entire body ceases to function. Furthermore, blood is essential for delivering the necessary nutrients to muscles during movement. The iron level in the human body significantly affects cardiovascular health, and both deficiencies and excesses can lead to severe complications . According to statistics from the Turkish Statistical Institute (TÜİK), circulation-related diseases ranked first in 2022, accounting for 35.4% of all cases. Among the 504,839 individuals included in the study, 178,501 died due to circulatory system diseases, 88,563 of whom were women.

Deterioration of heart health frequently leads to diastolic dysfunction, which is commonly associated with chronic hypertension, aging, particularly female gender, obesity, diabetes, chronic kidney disease, and cardiovascular diseases. High levels of LDL cholesterol and triglycerides in the blood play a significant role in the development of cardiovascular diseases. Studies have demonstrated that regular aerobic exercise, performed at controlled intensity levels, reduces triglycerides, total cholesterol, and LDL cholesterol while increasing HDL cholesterol, which benefits heart health.

Experimental studies have indicated that aging is associated with an increased risk of diastolic dysfunction in the heart. Aging is linked to numerous changes and adaptations in the cardiovascular system. While vascular and ventricular wall thickness increases, arterial compliance, endothelial function, and ventricular contractility decrease. Studies have reported that individuals who engage in regular exercise exhibit functional adaptations in heart performance, leading to a minimally enlarged and stronger heart. Consequently, due to the increased demand for blood during exercise, the heart's pumping capacity and cardiac output are enhanced. Research also indicates that physical activities with varying intensity levels improve well-being among adults while reducing the risk of cardiovascular diseases and cancer.

Although exercise is known for its many positive effects on the human body, individuals often lose interest over time. While exercise is expected to be an integral part of life, it gradually shifts away from becoming a routine. The primary reason for this decline is cited as lack of time. Historically, exercises recommended by medical experts for health improvement have involved continuous, moderate-intensity training over long periods, which can eventually lead to boredom or time constraints for individuals. One such exercise type is MICT (Moderate Intensity Continuous Training), characterized by continuous moderate-intensity workouts, typically performed at 50-60% intensity for durations ranging between 20-40 minutes. However, recent research suggests that short-duration, high-intensity interval training (HIIT) can also yield significant health benefits. HIIT, known as High-Intensity Interval Training, is increasingly recognized as a viable exercise option even for previously inactive individuals. HIIT is highly adaptable and can be implemented across various exercise domains. Due to its flexibility and efficiency, HIIT is frequently incorporated into exercise programs across different demographics. Given that many individuals struggle with time constraints, the shorter duration of HIIT sessions presents an opportunity for those with busy schedules to engage in regular exercise.

Being tested
Exercise
Keywords
Diastolic Dysfunction, Exercise, High Intensity Interval Training, Moderate Intensity Continuous Training, Women Health
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    HIIT Group

Study groups in NCT06945913
Study groupRoleWhat they receive
HIIT GroupActive comparatorThe first group (n=20) performed high-intensity interval training (HIIT) swimming exercises.
Receives: Behavioral: Exercise
MICT GroupSham comparatorThe second group (n=20) performed moderate-intensity continuous training (MICT) swimming exercises.
Receives: Behavioral: Exercise
Non exercise GroupNo interventionThe control group (n=20) did not engage in any exercise intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate Measurement by Electrocardiography

    Heart rate will be measured using a GE Healthcare MAC 2000 ECG device after 10 minutes of rest.

    Unit of Measure: Beats per minute (bpm)

    Measured: 6 months

  2. P Wave Duration

    The duration of the P wave will be measured using standard 12-lead ECG recordings.

    Unit of Measure: Milliseconds (ms)

    Measured: 6 months

  3. PR Interval

    The PR interval will be measured using standard 12-lead ECG recordings. Unit of Measure: Milliseconds (ms)

    Measured: 6 months

  4. QRS Duration

    The QRS duration will be measured using standard 12-lead ECG recordings. Unit of Measure: Milliseconds (ms)

    Measured: 6 months

  5. QT Interval

    The QT interval will be measured using standard 12-lead ECG recordings. Unit of Measure: Milliseconds (ms)

    Measured: 6 months

  6. Corrected QT Interval (QTc)

    The corrected QT interval (QTc) will be measured using standard 12-lead ECG recordings.

    Unit of Measure: Milliseconds (ms)

    Measured: 6 months

Secondary outcomes (13)
  1. Cardiac Cavity Dimensions by Echocardiography

    Left ventricular internal diameter, left atrial size, and other cardiac cavity dimensions will be measured using Philips transthoracic echocardiography.

    Unit of Measure: Millimeters (mm)

    Measured: 6 months

  2. Interventricular Septal Thickness

    Measurements of interventricular septal thickness at end-diastole will be taken using echocardiography.

    Unit of Measure: Millimeters (mm)

    Measured: 6 months

  3. Posterior Wall Thickness

    Measurements of posterior wall thickness at end-diastole will be taken using echocardiography.

    Unit of Measure: Millimeters (mm)

    Measured: 6 months

  4. Systolic Function - Ejection Fraction

    Left ventricular systolic function will be evaluated using ejection fraction (EF) by the modified Simpson method.

    Unit of Measure: Percentage (%)

    Measured: 6 months

  5. Diastolic Function - Early Diastolic Filling Velocity (E)

    Early diastolic filling velocity will be measured using Doppler and tissue Doppler imaging.

    Unit of Measure: Centimeters per second (cm/s)

    Measured: 6 months

  6. Diastolic Function - Late Diastolic Filling Velocity (A)

    Late diastolic filling velocity will be measured using Doppler and tissue Doppler imaging.

    Unit of Measure: Centimeters per second (cm/s)

    Measured: 6 months

  7. Diastolic Function - E/A Ratio

    The ratio of early to late diastolic filling velocity (E/A) will be calculated. Unit of Measure: Unitless

    Measured: 6 months

  8. Diastolic Function - Isovolumic Relaxation Time (IVRT)

    Isovolumic relaxation time will be measured using Doppler and tissue Doppler imaging.

    Unit of Measure: Milliseconds (ms)

    Measured: 6 months

  9. Diastolic Function - Deceleration Time (DT)

    Deceleration time will be measured using Doppler and tissue Doppler imaging. Unit of Measure: Milliseconds (ms)

    Measured: 6 months

  10. Diastolic Function - Early Myocardial Tissue Velocity (Em)

    Early myocardial tissue velocity will be measured using tissue Doppler imaging. Unit of Measure: Centimeters per second (cm/s)

    Measured: 6 months

  11. Diastolic Function - Late Myocardial Tissue Velocity (Am)

    Late myocardial tissue velocity will be measured using tissue Doppler imaging. Unit of Measure: Centimeters per second (cm/s)

    Measured: 6 months

  12. Diastolic Function - Em/Am Ratio

    Description: The ratio of early to late myocardial tissue velocity (Em/Am) will be calculated.

    Unit of Measure: Unitless

    Measured: 6 months

  13. Diastolic Function - E/Em Ratio

    The ratio of early diastolic filling velocity to early myocardial tissue velocity (E/Em) will be calculated.

    Unit of Measure: Unitless

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion10 Jul 2025 (estimated)
  4. Study completion15 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study was conducted with three groups: The first group (n=20) performed high-intensity interval training (HIIT) swimming exercises. The second group (n=20) performed moderate-intensity continuous training (MICT) swimming exercises. The control group (n=20) did not engage in any exercise intervention.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945913
Sponsor's protocol ID
UU-SBF-MBC-01
Status last verified
Apr 2025
First submitted
10 Mar 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Diastolic Dysfunction, run by Uşak University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Merve BOZ CİNCİ, Lecturer (+905533577475, mervebozcinci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Measurement by Electrocardiography (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in