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Quality of Life Related to Health in Spa Users

Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03952897
Enrollment
80
Registered
2019-05-16
Start date
2018-05-01
Completion date
2019-12-01
Last updated
2019-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis, Knee Osteoarthritis, Rheumatoid Arthritis

Keywords

knee osteoarthritis, rheumatoid arthritis, balneology, hip balneology

Brief summary

Hypothesis: The spa therapy treatment could improve health-related quality of life (HRQOL) in subjects with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis. Main objective: Analyze if HRQOL in patients with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis is modified by spa therapy treatment in the spa of Fitero (Spain). Design: Prospective observational study Participants: Fitero's spa users aged between 45-80 years old, diagnosed with knee and/or hip osteoarthritis, and also with rheumatoid arthritis. At least 40 patients of each type will be included in the study. Participants must be receiving a treatment of at least ten days. Main Variable: The scores obtained in the Euroqol5Dimensions-5Levels questionnaire (EQ-5D-5L) (for all subjects), the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) questionnaire, for subjects with knee and/or hip osteoarthritis, and the Health Assessment Questionnaire (HAQ), for subjects with rheumatoid arthritis. Other variables: sociodemographic, anthropometric, clinics, and related with spa treatment. Follow-up duration: 9 months.

Interventions

10 days of balneotherapy with immersion techniques using Fitero spa water.

Sponsors

University of Castilla-La Mancha
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis * balneotherapy treatment of at least 10 days. * physically and mentally able to complete questionnaires

Exclusion criteria

* have followed a balneotherapy treatment in the six previous month

Design outcomes

Primary

MeasureTime frameDescription
HAQ (Health Assessment Questionnaire)-Disability of rheumatic patientsFrom 1st March 2019 to 1st December 2019Health Assessment Questionnaire (HAQ) assays the disability of rheumatic patients to carry out daily life activities. The questionary consists on 20 daily life questions, grouped in 8 areas, each one containing two or three questions related to daily life activities. Each question is scored from 0-3. 0 means done without difficulties (no disability), 3 score is impossible to do (completely disabled). The average of all responses is done. Average scores from 0-1 represent mild to moderate difficulty, 1-2 means moderate to severe disability, 3-2 indicates severe to very severe disability.
WOMACFrom 1st March 2019 to 1st December 2019Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026