NCT06945913

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

March 10, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Diastolic DysfunctionExerciseHigh Intensity Interval TrainingModerate Intensity Continuous TrainingWomen Health

Outcome Measures

Primary Outcomes (6)

  • 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)

    6 months

  • P Wave Duration

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

    6 months

  • PR Interval

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

    6 months

  • QRS Duration

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

    6 months

  • QT Interval

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

    6 months

  • Corrected QT Interval (QTc)

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

    6 months

Secondary Outcomes (13)

  • Cardiac Cavity Dimensions by Echocardiography

    6 months

  • Interventricular Septal Thickness

    6 months

  • Posterior Wall Thickness

    6 months

  • Systolic Function - Ejection Fraction

    6 months

  • Diastolic Function - Early Diastolic Filling Velocity (E)

    6 months

  • +8 more secondary outcomes

Study Arms (3)

HIIT Group

ACTIVE COMPARATOR

The first group (n=20) performed high-intensity interval training (HIIT) swimming exercises.

Behavioral: Exercise

MICT Group

SHAM COMPARATOR

The second group (n=20) performed moderate-intensity continuous training (MICT) swimming exercises.

Behavioral: Exercise

Non exercise Group

NO INTERVENTION

The control group (n=20) did not engage in any exercise intervention.

Interventions

ExerciseBEHAVIORAL

HIIT Group

HIIT GroupMICT Group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uşak U

Uşak, Merkez, 64100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Merve BOZ CİNCİ, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 10, 2025

First Posted

April 27, 2025

Study Start

May 1, 2025

Primary Completion

July 10, 2025

Study Completion

July 15, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations