NCT07005375

Brief Summary

Effect of bathing in the thermal mineral water well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2024

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

July 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

April 21, 2025

Last Update Submit

June 6, 2025

Conditions

Keywords

low back pain, fatigueperformance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

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.

Behavioral: thermal mineral water bath

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

Behavioral: thermal mineral water bath

Interventions

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.

Also known as: water, thermal water, mineral water
AthletesAthletes/rowing

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Budai Irgalmasrendi Kórház Nonprofit Kft.

Budapest, Budapest, 1027, Hungary

Location

MeSH Terms

Conditions

Low Back PainFatigue

Interventions

WaterWater PollutionMineral Waters

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomized, controlled, single-blind study.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, controlled, single-blind study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 21, 2025

First Posted

June 5, 2025

Study Start

July 1, 2024

Primary Completion

December 11, 2025

Study Completion

December 31, 2025

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations