Does Balnotherapy Influence the Qualitiy of Life in SLE

Not Applicable

Completed

• Conditions: SLE
• Interventions: Other: balneotherapy

• Registration Number: NCT04392791
• Lead Sponsor: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Brief Summary

The aim of this study was to investigate the effects of balneotherapy on the quality of life and on work productivity of SLE patients.

Detailed Description

SLE patients in remission/low disease activity of three immunology centers were included in this randomized, controlled, follow-up study. In addition to the standard of care (SOC) sixteen out of the thirty SLE patients received balneotherapy (15 times, for 30 minutes) and fourteen patients received the SOC only. Prevalidated survey instruments including LupusQol, SF36, and WPAI questionnaires were recorded.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-19
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diagnosis of SLE according to SLICC/ACR, 2012 criteria;
• remission or low disease activity, evaluated with SLEDAI-2K

Exclusion Criteria

• explorable psychiatric disease
• general contraindications to balneotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated group	balneotherapy	The participants received thermal water therapy

Primary Outcome Measures

Name	Time	Method
Lupus Quality of Life (LupusQoL)	10 weeks	Considering the previous4-week period,34 items comprising eight domains, evaluates the physical health, emotional health, body image, pain, planning, fatigue, intimate relationshipsand burden to others. The scoring is made by domains, ranged from 0 (worst) to 100 (best
WPAI-Lupus is a disease specific questionnaire developed to measure work capacity and daily activity	10 weeks	Six questions, covering four topics records the prior 7 days impairment: absenteeism, presenteeism, overall work impairment, and activity impairment(Reilly). Evaluation is performed by domain, expressed as a percentage. A higher percentage corresponds to higher impairment, worse productivity.
The Short Form Health Survey (SF-36)	10 weeks	Evaluatingthe previous four weeks, it contains a total of 36 questions in 8 categories (physical activity, role limitation due to physical problems, physical pain, general health, vitality, social activity, role limitation due to emotional problems, and general mental health). Responses are rated 0-100 per topic, with 0 being the worst and 100 being the best quality of life

Trial Locations

Locations (1)

Polyclinic of Hospitaller Brothers of St. John of God; 🇭🇺 Budapest, Hungary