NCT06923969

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

March 23, 2025

Last Update Submit

February 4, 2026

Conditions

Osteoarthritis

Keywords

BalneotherapyEchocardiographyWellnessHeart

Outcome Measures

Primary Outcomes (3)

  • Change in mitral peak E wave velocity

    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

    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

    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 Outcomes (3)

  • Change in left ventricular ejection fraction

    Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program

  • Change in mean aortic gradient

    Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program

  • Change in maximum aortic gradient

    Baseline (before balneotherapy) and immediately after completion of the 15-day balneotherapy program

Interventions

balneotherapyOTHER

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Military Hospital, 1. Murat Caddesi Osmangazi

Bursa, Nilüfer, 16300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Balneology

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation (PM&R) physician, MD.

Study Record Dates

First Submitted

March 23, 2025

First Posted

April 11, 2025

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

TU(1)