SLE
Conditions
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.
Interventions
OTHERbalneotherapy
Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes
Sponsors
University of Debrecen
Szeged University
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hungary
Outcome results
None listed