- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923969
Balneotherapy and Echocardiographic Findings in Osteoarthritis
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nilüfer
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Bursa, Nilüfer, Turkey (Türkiye), 16300
- Bursa Military Hospital, 1. Murat Caddesi Osmangazi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-PMR-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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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