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Completed

NCT Number: NCT04392791

Does Balnotherapy Influence the Qualitiy of Life in SLE

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

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Key information

Conditions

SLE

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinic of Hospitaller Brothers of St. John of God

Budapest, 1023, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balneotherapy

Other

Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes

Primary outcomes

  1. Lupus Quality of Life (LupusQoL)

    Time frame: 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

  2. WPAI-Lupus is a disease specific questionnaire developed to measure work capacity and daily activity

    Time frame: 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.

  3. The Short Form Health Survey (SF-36)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Other

Collaborators

  • Szeged University
  • University of Debrecen

Registry information

Official study title

Balnotherapy in SLE, the First Randomised Controlled Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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