Activity-Based Functional Exercise for Disability in Systemic Sclerosis: Protocol for a Feasibility Randomised Controlled Trial.

INTRODUCTION

Systemic Sclerosis (SSc) is associated with substantial disability in affected patients. Although exercise interventions for SSc have been developed, most focus on isolated body segments rather than global disability. Thus, this study aims to assess the feasibility of a functional activity-based exercise programme designed to address disability in individuals with SSc.

METHODS

This feasibility study protocol is designed as a randomised controlled mixed-methods trial. It will include individuals with SSc aged 18-65 years and with a score ≥ 1 on the Scleroderma Health Assessment Questionnaire (SHAQ). Participants will be randomly allocated to either a control group, receiving an educational booklet on the disease, or an intervention group receiving the booklet plus a 10-week supervised functional exercise protocol (twice weekly). Feasibility outcomes include recruitment and retention rates, adherence, safety, and adverse events. Preliminary clinical outcomes will address disability level, physical function, fatigue, resilience, symptoms of anxiety and depression, and perceived change. Quantitative data will be analysed using descriptive and inferential statistics, while qualitative data will undergo thematic content analysis.

ETHICAL APPROVAL: The study was approved by the Institutional Ethics Committee (Approval Number: 6.992.710).

RESULTS

The study is in its initial phase. The reference clinic has 219 registered patients, of whom 183 (83.6%) are preliminarily eligible. Recruitment and subsequent feasibility results are ongoing.

CONCLUSION

This protocol proposes an innovative and low-cost approach, whose results will support refinements for a more rigorous clinical trial, despite potential logistical and disease-related limitations.