NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Sheffield Hallam University
Conditions: Systemic Sclerosis
Interventions: Exercise programme
Countries: United Kingdom
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 identified as a key stressor and the most prevalent and debilitating symptom of SSc. Both, affect significantly quality of life (QoL) domains. Pharmacological therapeutic strategies have not been proved sufficiently effective in the management of SSc-induced pain and fatigue. Evidently the effectiveness of non-pharmacological interventions (e.g., exercise, cognitive behavioural therapy) is limited, although for some of them (i.e., exercise) evidence is promising. As yet, the effects of a feasible, long-term, tailored exercise programme on pain and fatigue in people with SSc have not been explored. Therefore, the investigators propose a multicentre (n=5) research clinical trial to assess the effect of a previously established, supervised 12-week combined (aerobic and resistance training) exercise programme on pain and fatigue. The 26-month study will recruit 180 people with SSc that will be allocated randomly to two groups. Group A will perform the exercise programme parallel to standard care and Group B will receive the standard care alone. All participants will be followed for 24-weeks. Results will inform clinical practice and may improve QoL for people with SSc.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Criteria: * 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
- Sheffield, United Kingdom