NCT07840430Not yet recruiting
Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- University of Aarhus
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07840430
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 15 Oct 2026 to the primary completion date, 30 Apr 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Evidence that the patient cannot participate in a self-guided exercise programme or adhere to study procedures (e.g. due to cognitive impairment)
Other
- 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.
Who the study is looking for
- Adults 18 years and older
- Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
- Able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Medicine - The Section for Rheumatology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Department for Rheumatology and Spine Diseases, Copenhagen University Hospital - Rigshospitalet Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Department of Rheumatology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.