Balneotherapy and Echocardiographic Findings in Osteoarthritis

February 4, 2026 updated by: Taner Dandinoğlu, Bursa City Hospital

Effects of Balneotherapy on Echocardiographic Parameters in Adults and Elderly Patients With Osteoarthritis

This prospective observational study aims to evaluate changes in heart function using echocardiography before and after a standardized balneotherapy program in adult and elderly patients with osteoarthritis.

Balneotherapy is commonly used by patients with osteoarthritis, especially in older age groups, who may also have known or unrecognized cardiovascular conditions. For this reason, heart function is evaluated using transthoracic echocardiography prior to the start of balneotherapy and again after completion of the treatment program.

The study focuses on changes in echocardiographic parameters related to left ventricular systolic and diastolic function. By comparing measurements obtained before and after balneotherapy, this study seeks to improve understanding of the potential effects of balneotherapy on cardiac function in patients with osteoarthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Balneotherapy is frequently preferred by adult and elderly patients with osteoarthritis as part of rehabilitation programs. This population may have a higher prevalence of overt or subclinical cardiovascular disease; therefore, cardiovascular evaluation before and after balneotherapy may be clinically relevant.

In this prospective observational study, patients with osteoarthritis who are scheduled to undergo a standardized balneotherapy program are evaluated using transthoracic echocardiography prior to treatment initiation and again after completion of the program. Echocardiographic examinations are performed to assess parameters related to left ventricular systolic and diastolic function, as well as aortic hemodynamics.

The balneotherapy program consists of head-out immersion in thermal pools with acratothermal water at a temperature of approximately 38 °C, applied for 20 minutes per session, 5 days per week, over a 15-day period. Echocardiographic measurements obtained before and after the intervention are compared to evaluate potential changes in cardiac function associated with balneotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Nilüfer
      • Bursa, Nilüfer, Turkey (Türkiye), 16300
        • Bursa Military Hospital, 1. Murat Caddesi Osmangazi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult and elderly patients diagnosed with osteoarthritis who are scheduled to undergo a standardized balneotherapy program at a tertiary care rehabilitation hospital. Eligible participants undergo transthoracic echocardiographic evaluation before initiation of balneotherapy and again after completion of the treatment program in order to assess potential changes in cardiac function.

Description

Inclusion Criterias:

  • Having balneotherapy sessions 5 days a week for total of three weeks
  • Having detailed echocardiography records

Exclusion Criterias:

  • Having history of major surgery,
  • cerebrovascular accident,
  • malignancy,
  • liver or renal failure,
  • immunodeficiency,
  • acute/chronic infection,
  • psychiatric disorders were exluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in mitral peak E wave velocity
Time Frame: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in mitral peak early diastolic (E) wave velocity measured by transthoracic echocardiography.
Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in mitral E/A ratio
Time Frame: Baseline and immediately after completion of the 15-day balneotherapy program
Change in the ratio of early (E) to late (A) diastolic transmitral flow velocities assessed by transthoracic echocardiography.
Baseline and immediately after completion of the 15-day balneotherapy program
Change in E/E' ratio
Time Frame: Baseline and immediately after completion of the 15-day balneotherapy program
Change in the ratio of early transmitral flow velocity (E) to early diastolic mitral annular velocity (E') measured by tissue Doppler imaging.
Baseline and immediately after completion of the 15-day balneotherapy program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in left ventricular ejection fraction
Time Frame: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in left ventricular ejection fraction assessed by transthoracic echocardiography.
Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in mean aortic gradient
Time Frame: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in mean transaortic pressure gradient measured by continuous-wave Doppler echocardiography.
Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in maximum aortic gradient
Time Frame: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in maximum transaortic pressure gradient measured by continuous-wave Doppler echocardiography.
Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bursa City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-PMR-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Research data will be available upon request from author

(Taner Dandinoglu MD. e-mail: dandinoglu@gmail.com)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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