Exercise in people with systemic sclerosis
Research type
Research Study
Full title
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.
IRAS ID
302054
Contact name
Markos Klonizakis
Contact email
Sponsor organisation
Sheffield Hallam University
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Systemic sclerosis (SSc) is an autoimmune rheumatoid disease with a plethora of clinical symptoms such as pain (mainly limited to fingers and toes due to blood flow restriction within the blood vessels) and chronic fatigue. Pharmacological interventions have not been able to improve sufficiently these symptoms and as a result people's with SSc quality of life (QoL) is dramatically affected. Regular physical activity and/or exercise have demonstrated promising results in improving these two outcomes (e.g., pain and fatigue), nevertheless, the evidence is limited and a structured individualised exercise programme has yet to be tested. Our research team has developed and tested an individualised, structured, combined (e.g., aerobic and weight training) exercise programme which is able to improve the blood's vessels function with promising results in improving pain and fatigue in people with SSc. The exercise session lasts 45mins and participants perform two sessions per week for 12 weeks. Therefore the current research study aims to assess the effects of a combined exercise programme on pain and fatigue in people with SSc. This is a large randomised clinical trial that will take place over a period of 26 months. 180 participants will be allocated at random into two groups: Group A will perform the 12-week exercise programme and will receive the standard medical treatment (if applicable) and Group B will only receive the standard medical treatment. Group B will be offered the same 12-week exercise programme following the completion of the study. Prior to group allocation, laboratory-based assessments will be performed including demographics and clinical history, measures of pain, fatigue and QoL using questionnaires, a non-invasive assessment of blood vessels, a small blood sample to assess blood vessel markers, and an exercise test to assess fitness. The assessments will be repeated at 12- and 24-weeks.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
21/LO/0743
Date of REC Opinion
12 Nov 2021
REC opinion
Further Information Favourable Opinion