Does Balnotherapy Influence the Qualitiy of Life in SLE
Balnotherapy in SLE, the First Randomised Controlled Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 29, 2022
September 1, 2022
2.5 years
May 5, 2020
September 28, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Lupus Quality of Life (LupusQoL)
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
10 weeks
WPAI-Lupus is a disease specific questionnaire developed to measure work capacity and daily activity
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.
10 weeks
The Short Form Health Survey (SF-36)
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
10 weeks
Study Arms (2)
Treated group
ACTIVE COMPARATORThe participants received thermal water therapy
Control group
NO INTERVENTIONThe participants haven't received thermal water therapy
Interventions
Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes
Eligibility Criteria
You may qualify if:
- diagnosis of SLE according to SLICC/ACR, 2012 criteria;
- remission or low disease activity, evaluated with SLEDAI-2K
You may not qualify if:
- explorable psychiatric disease
- general contraindications to balneotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Polyclinic of the Hospitaller Brothers of St. John of God, Budapestlead
- University of Debrecencollaborator
- Szeged Universitycollaborator
Study Sites (1)
Polyclinic of Hospitaller Brothers of St. John of God
Budapest, 1023, Hungary
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamás Bender, MD, PhD. DSC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD. DSC Head of Phisioterapy
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 19, 2020
Study Start
December 1, 2017
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
September 29, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share