Quality of Life Related to Health in Spa Users

NCT ID: NCT03952897

Last Updated: 2019-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-01

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.

Detailed Description

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Conditions

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Knee Osteoarthritis Hip Osteoarthritis Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Subjects treated with balneotherapy for 10 days, previously diagnosed with knee and/or hip osteoarthritis, and subjects previously diagnosed with rheumatoid arthritis.

balneotherapy

Intervention Type OTHER

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

Interventions

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balneotherapy

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

Intervention Type OTHER

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inés Martínez-Galán, MD

Role: PRINCIPAL_INVESTIGATOR

University of Castilla-La Mancha

Locations

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Universidad de Castilla-La Mancha

Toledo, , Spain

Site Status

Countries

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Spain

Other Identifiers

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EO-BALNEO-19

Identifier Type: -

Identifier Source: org_study_id

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