Quality of Life Related to Health in Spa Users

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis, Hip Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Other: balneotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Subjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis. | Other: balneotherapy<br>* 10 days of balneotherapy with immersion techniques using Fitero spa water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients | Health 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. | From 1st March 2019 to 1st December 2019 | 
| WOMAC | Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) | From 1st March 2019 to 1st December 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, rheumatoid arthritis, balneology, hip balneology