Quality of Life Related to Health in Spa Users

NCT03952897 | Unknown DMC

• 1 other identifier: EO-BALNEO-19
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis; Rheumatoid Arthritis

Keywords

knee osteoarthritis; rheumatoid arthritis; balneology; hip balneology

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

balneotherapy OTHER

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

Group 1

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Users of Fitero spa

You may qualify if:

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

You may not qualify if:

• have followed a balneotherapy treatment in the six previous month

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Universidad de Castilla-La Mancha

Toledo, 45122, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Arthritis, Rheumatoid

Interventions

Balneology

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Inés Martínez-Galán, MD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 16, 2019
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

ES (1)