Status:
COMPLETED
Exercise in People With Systemic Sclerosis
Lead Sponsor:
Sheffield Hallam University
Collaborating Sponsors:
Leiden University
Rikshospitalet University Hospital
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Raynaud's phenomenon and digital ulceration are two of the most common disease manifestations leading to digital and/or toe pain in systemic sclerosis (SSc). In addition to pain, fatigue has been iden...
Detailed Description
Background Pain in SSc originates from disease activity and is one of the most important patient-reported outcomes in rheumatology. It is estimated that up to 83% of people with SSc have significant p...
Eligibility Criteria
Inclusion
- A diagnosis of Systemic Sclerosis according to the 2013 ACR/EULAR criteria experiencing Raynaud's phenomenon
- Age over 18 years old
- Ability to perform the prescribed exercise regime
Exclusion
- Active disease-related exacerbations (e.g., active digital ulcers)
- Change of medical treatment (I.e., medical treatment which is related with the vascular function and blood flow such as calcium channel blockers and vasodilators) within the last 3 months (however, potential participants will be able to take part following that period)
- Advanced pulmonary involvement (e.g., pulmonary arterial hypertension)
- New York Heart Association class 3 or 4
- Inability to exercise
- Current pregnancy
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05234671
Start Date
September 1 2021
End Date
February 28 2024
Last Update
October 15 2024
Active Locations (1)
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1
Sheffield Hallam University
Sheffield, United Kingdom, S10 2BP