OsteoarthritisNCT06923969
Balneotherapy and Echocardiographic Findings in Osteoarthritis
An observational study of Osteoarthritis, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- balneotherapy
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Having balneotherapy sessions 5 days a week for total of three weeks
- Having detailed echocardiography records
Who cannot join
- Having history of major surgery,
- cerebrovascular accident,
- malignancy,
- liver or renal failure,
- immunodeficiency,
- acute/chronic infection,
- psychiatric disorders were exluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Military Hospital, 1. Murat Caddesi Osmangazi
Bursa, Nilüfer, 16300
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- balneotherapy
- Keywords
- Balneotherapy, Echocardiography, Wellness, Heart
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balneotherapyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitral peak E wave velocity
Change in mitral peak early diastolic (E) wave velocity measured by transthoracic echocardiography.
Measured: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in mitral E/A ratio
Change in the ratio of early (E) to late (A) diastolic transmitral flow velocities assessed by transthoracic echocardiography.
Measured: Baseline and immediately after completion of the 15-day balneotherapy program
Change in E/E' ratio
Change in the ratio of early transmitral flow velocity (E) to early diastolic mitral annular velocity (E') measured by tissue Doppler imaging.
Measured: Baseline and immediately after completion of the 15-day balneotherapy program
Secondary outcomes (3)
Change in left ventricular ejection fraction
Change in left ventricular ejection fraction assessed by transthoracic echocardiography.
Measured: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in mean aortic gradient
Change in mean transaortic pressure gradient measured by continuous-wave Doppler echocardiography.
Measured: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Change in maximum aortic gradient
Change in maximum transaortic pressure gradient measured by continuous-wave Doppler echocardiography.
Measured: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jan 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taner Dandinoğlu, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923969
- Sponsor's protocol ID
- 2026-PMR-6
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Research data will be available upon request from author (Taner Dandinoglu MD. e-mail: dandinoglu@gmail.com)
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balneotherapy on Echocardiographic Parameters in Adults and Elderly Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT06923969
- Acronym / sponsor ID
- 2026-PMR-6
- Conditions
- Osteoarthritis
- Keywords
- Balneotherapy, Echocardiography, Wellness, Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Having balneotherapy sessions 5 days a week for total of three weeks
- Having detailed echocardiography records
Key exclusion criteria (7 listed)
- Having history of major surgery,
- cerebrovascular accident,
- malignancy,
- liver or renal failure,
- immunodeficiency,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balneotherapy | Other | – |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change in left ventricular ejection fraction
Time frame: 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 maximum aortic gradient
Time frame: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided. Research data will be available upon request from author (Taner Dandinoglu MD. e-mail: dandinoglu@gmail.com)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Bursa City Hospital 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitral peak E wave velocity (time frame: Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program). The study lists 3 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 6 Feb 2026.