The effects of exercise in patients with Systemic Sclerosis
Research type
Research Study
Full title
Investigating the effectiveness and feasibility of exercise on microcirculatory parameters and quality of life in systemic sclerosis patients.
IRAS ID
68096
Contact name
Alexandros Mitropoulos
Contact email
Sponsor organisation
Sheffield Hallam University
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
Systemic Sclerosis (SSc) is a generalised disease mainly affecting the skin, causing pain and fatigue, affecting patients’ quality of life and incurring NHS large costs. Recent studies have shown that problems in the wall of the small blood vessels play an important role in the disease’s development. New medicines have been designed to restore normal function but they require lengthy clinical trials before routine use and have potential side effects. This suggests the need to try developing non-pharmacological interventions. Data from previous studies in other patient groups with similar problems in the vein wall show that blood flow improves following a period of exercise training. This indicates that exercise therapy might be an additional, cost-effective method for improving clinical management and quality of life of these patients.\nTwo interconnected studies aim to find out whether exercise is beneficial for patients with SSc and specifically whether this has the potential to reduce the number of episodes of blood vessel tightening and to improve blood flow. Consenting SSc patients will participate either in a 12-week exercise intervention, two times/week lasting 60mins each session, or they will be included to the control group where they will be assessed pre- and post-intervention without exercising. At the beginning and after the training intervetion we will investigate the number of times blood vessel tightening occurs in all participants, as well as the flow of blood and behaviour of the small blood vessels beneath the skin around their finger area. \nThis will be achieved using a painless, non-invasive technique called Laser Doppler Fluximetry (LDF). We will also measure patients’ physical activity levels and assess their quality of life with a validated questionnaire. Smoking, medication use and their disease subgroup will be taken into account during analysis.\nThe study will be undertaken at Sheffield Hallam University facilities at Collegiate campus.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0811
Date of REC Opinion
28 Apr 2016
REC opinion
Further Information Favourable Opinion