Home-Based Exercise to Improve Quality of Life in Systemic Sclerosis
Tests a home exercise programme alongside usual care in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis
Key facts
- Where
- Aarhus, Glostrup Municipality, and Odense, DenmarkSee the 3 sites
Where in Denmark
- Department of Clinical Medicine - The Section for Rheumatology, Aarhus University HospitalAarhus, DenmarkNo longer taking part
- Department for Rheumatology and Spine Diseases, Copenhagen University Hospital - RigshospitaletGlostrup Municipality, DenmarkNo longer taking part
- Department of Rheumatology, Odense University HospitalOdense, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT07840430
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
Home-based Exercise Compared to Usual Care for Improving Health-related Quality of Life in Systemic Sclerosis - a Multicentre Randomised Controlled Trial (the ScleroStrong Trial)
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.
Inclusion: Adults 18 years and older; Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months; Able to provide informed consent.
Exclusion: 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.