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| ID | Type | Description | Link |
|---|---|---|---|
| NNGYK/GYSZ/3848-8/2024 | Other Identifier | NNGYK/GYSZ/3848-8/2024 |
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Effect of bathing in the thermal mineral water well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Athletes/rowing | Active Comparator | 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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| Athletes | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thermal mineral water bath | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Exclusion Criteria:
General contraindications of balneotherapy:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Budai Irgalmasrendi Kórház Nonprofit Kft. | Budapest | Budapest | 1027 | Hungary |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014867 | Water |
| D014876 | Water Pollution |
| D008900 | Mineral Waters |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Randomized, controlled, single-blind study.
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Randomized, controlled, single-blind study.
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| 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004787 | Environmental Pollution |
| D011634 | Public Health |
| D004778 | Environment and Public Health |