Quality of Life Related to Health in Spa Users

Sponsor

University of Castilla-La Mancha (Other)

Overall Status

Unknown status

CT.gov ID

NCT03952897

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Hip Osteoarthritis Rheumatoid Arthritis	Other: balneotherapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Group 1

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

Other: balneotherapy

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

Outcome Measures

Primary Outcome Measures

HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients [From 1st March 2019 to 1st December 2019]
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".
WOMAC [From 1st March 2019 to 1st December 2019]
Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC)