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NCT07840430
Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis
Conditions: Systemic Sclerosis (SSc)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 270
Sponsor: University of Aarhus
Location: Department of Clinical Medicine - The Section for Rheumatology, Aarhus University Hospital Aarhus
Summary
The goal of this randomised controlled trial is to evaluate whether a partially supervised, home-based exercise programme in addition to usual care improves health-related quality of life in adults with systemic sclerosis.
The main questions it aims to answer are:
1. Does a partially supervised, home-based exercise programme improve health-related quality of life, measured by the EQ-5D-5L, compared with usual care alone after 6 months?
2. Is the partially supervised, home-based exercise programme cost-effective compared with usual care over a 12-month period?
Researchers will compare the partially supervised, home-based exercise programme plus usual care with usual care alone to determine whether the partially supervised, home-based exercise programme improves health-related quality of life, disease impact, physical function, physical activity, and represents a cost-effective treatment strategy.
Participants will:
* Be randomly assigned to either the partially supervised, home-based exercise programme plus usual care or usual care alone.
* Complete questionnaires at baseline and after 3, 6, 9, and 12 months.
* Undergo physical function assessments at baseline and after 6 months.
* If allocated to the intervention group, perform a 24-week home-based exercise programme consisting of three weekly sessions of aerobic and resistance exercise, supported by six online physiotherapist consultations, followed by 28 weeks of self-guided exercise.
* Complete follow-up assessments of healthcare utilization, productivity, adherence, and adverse events throughout the 12-month study period.
Eligibility Criteria
Inclusion Criteria:
* Adults 18 years and older
* Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
* Able to provide informed consent
Exclusion Criteria:
* Evidence that the patient cannot participate in a self-guided exercise programme or adhere to study procedures (e.g. due to cognitive impairment)
* Patient cannot understand or speak Danish (for Aarhus University Hospital, Odense University Hospital, and Copenhagen University Hospital - Rigshospitalet) or Italian (for University Hospital of Pisa).
* Patient lacks an email address to receive electronic questionnaires.
Source: ClinicalTrials.gov (NCT07840430). StuddyBuddy aggregates publicly available trial information.