- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07005375
- Original Trial
The Effect of Bathing in the Thermal Mineral Water on the Pain and Performance of Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In rowing sports, where the same series of movements are repeated thousands of times, the lower lumbar region is the most stressed part. Because of this, even training on an ergometer can cause numerous lower back problems, even among competitors. In addition, rowers use many muscle groups during their sport, for which the beneficial effect of thermal medicinal waters, affecting the entire musculoskeletal system, can be beneficial, and is used for rehabilitation purposes in several countries.
Studies describe the numerous positive effects of bathing in warm water (37-46°C) in increasing blood flow, regulating blood sugar, and even the positive response of the vascular system.
The Palatinus Spa's water supply is provided by the drilled thermal wells of Margit Island of Budapest.
Regarding its type, the medicinal water is a low salt concentration, calcium-magnesium-hydrogen carbonate, chloride, and sulfate medicinal water, which also has a significant fluoride and metasilicic acid content. The total dissolved mineral content is 1205 mg/liter. In the study, we would conduct the clinical trial necessary for the "Margaret Island mineral water" / 37-38 °C / thermal mineral water of the Margitszigeti É. III well to be declared medicinal water.
Research Question Primary objective: Effect of bathing in the "Margaret Island mineral water" thermal mineral water of the Margaret Island III well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.
Secondary objective: To what extent does thermal water treatment lead to a change in the quality of life of those receiving it compared to their initial condition, and what is the magnitude of this change compared to the control group?
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Budapest, Hungary, 1027
- Hospital Budai Irgalmasrendi Kórház Nonprofit Kft.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Rowers coming from the surrounding area, with registration at the Hungarian Rowing Federation (MESZ), including competitive/touring and recreational/masters rowers
- Women and men between 18 and 75 years of age
- Participating in regular training for at least 6 months
- Signed informed consent form prior to the start of the study
Exclusion Criteria:
- Acute pain;
- Organic neurological deficit;
- Malignancy in the background;
- Pain attributable to inflammatory disease;
- Participants must not have received systemic or local steroid therapy, physiotherapy as a course of treatment, massage therapy, or balneotherapy as a course of treatment within 3 months prior to the study;
General contraindications of balneotherapy:
- unstable angina pectoris,
- uncontrolled hypertension,
- cardiac decompensation,
- respiratory failure,
- unbalanced endocrinological disease,
- acute febrile condition,
- infectious skin diseases,
- other serious internal, urogenital, and other diseases, urinary and fecal incontinence,
- decompensated psychosis and neurosis, lack of compliance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Athletes/rowing
Patients were enrolled if they met the inclusion and exclusion criteria.
The classification would be based on a randomization list.
Measurements, clinical examinations, and evaluation of pain and functional status-related quality of life will be performed before, immediately after the treatments, and 3 months later.
One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session.
Bathing in the thermal mineral water takes place in the medicinal water pool.
The control group does not receive balneotherapy.
Both groups can continue their usual training plan.
The thermal mineral water-treated group and the control group may not receive systemic or locally administered steroid therapy during the study, and the control group may not receive balneotherapy.
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One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session.
Bathing in the thermal mineral water takes place in the medicinal water pool.
The control group does not receive balneotherapy.
Both groups can continue their usual training plan.
Other Names:
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Active Comparator: Athletes
One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan. Rowers coming from the surrounding area, with registration at the Hungarian Rowing Federation |
One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session.
Bathing in the thermal mineral water takes place in the medicinal water pool.
The control group does not receive balneotherapy.
Both groups can continue their usual training plan.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group. This would be measured by the improvement in 6000-meter ergometer performance.
Time Frame: 3 months
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The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group.
This would be measured by the improvement in 6000-meter ergometer performance.
Examining the change in threshold load with improving parameters and heart rate variability (HRV) (examining how the heart is able to continuously change the duration between heartbeats (RR intervals) in response to changes in internal and external environmental loads, and thereby showing the heart's adaptation.
This adaptability of the heart is based on the optimal interplay and cooperation of the sympathetic and parasympathetic nervous systems.)
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The extent of the change in fatigue, muscle pain, and discomfort between workouts measured by VAS in the balneotherapy group compared to the change in the control group.
Time Frame: 3 months
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The extent of the change in fatigue, muscle pain, and discomfort between workouts measured by 1-10 points on a VAS in the balneotherapy group compared to the change in the control group.
Change in lumbar spine movement function in cm.
Specific questionnaire for lower back pain (Oswestry) Quality of life questionnaire (EuroQuol-5D-5L) Change in medication therapy used for pain.
The extent of change on the Borg scale 0-10 points (How much did you exert yourself?)
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3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Medicinal Water and Rowing
- NNGYK/GYSZ/3848-8/2024 (Other Identifier: NNGYK/GYSZ/3848-8/2024)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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