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Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis

Study acronym: ScleroStrong
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07840430
Lead Sponsor University of Aarhus
Collaborators: Aarhus University Hospital, Odense University Hospital, Rigshospitalet, Denmark, Pisa University Hospital
Conditions
(from sponsor)
Systemic Sclerosis (SSc)
Related terms Scleroderma, Diffuse, Scleroderma, Systemic
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov