NCT05234671Completed
Exercise in People With Systemic Sclerosis
Exploring the Effects of a Combined Exercise Programme on Pain and Fatigue Outcomes in People With Systemic Sclerosis: A Large Multi-centre Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 170 (actual)
- First submitted
- 14 Jan 2022
- Start date
- 1 Sept 2021
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- Sheffield Hallam University
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05234671
What you commit to
- Study type: Interventional
- Participants enrolled: 170
- From 1 Sept 2021 to the primary completion date, 30 Sept 2023
- 1 site 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
- Active disease-related exacerbations (e.g., active digital ulcers)
- Advanced pulmonary involvement (e.g., pulmonary arterial hypertension)
- New York Heart Association class 3 or 4
Lab values
- 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)
Other
- Inability to exercise
- Current pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheffield Hallam University Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.