Exploring the effects of a combined exercise programme on pain and fatigue outcomes in people with systemic sclerosis

Concept

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, this project will carry out 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.

Facts and Figures

Project Lead
M Klonizakis
Sheffield Hallam University
m.klonizakis@shu.ac.uk
FOREUM research grant: € 387.216
2021–2024

Meet the Team

Project Lead

M Klonizakis
Sheffield Hallam University
m.klonizakis@shu.ac.uk
A Mitropoulos
Sheffield Hallam University
T Vliet Vlieland
Leiden University Medical Centre
M Mattsson
Karolinska Institutet/Sunderby hospital
S Jacobsen
Copenhagen University
G Cuomo
L. Vanvitelli University
E Kouidi
Aristotle University of Thessaloniki

Final results

We recruited 170 participants, randomised into two groups (Exercise=86/Control=84), across all 6 sites. Ten participants dropped out before completing all study procedures (Exercise=5/Control=5; 6% overall). Groups were demographically (e.g., gender (female 80% vs 87%; Exercise vs Control) and disease-stage (diffuse n=66 vs n=63; Exercise vs Control) -comparable.

the end of the intervention, our exercise group participants experienced improvements in all Wellbeing domains and in particular at their Social (21.4 (4.9) vs 20.2 (5.3)), Functional (18.9 (5.7) vs 17.4 (5.4)) and Physical Wellbeing (22.1 (5.3) vs 20.6 (5.9), at a time where our control group participants experienced reductions (e.g., Social Wellbeing 19.1 (5.8) vs 20.5 (5.4)).

Similarly, our exercise group participants experienced a reduction in pain (0.6 (0.8) vs 0.8 (0.8)), breathing issues (0.4 (0.6) vs 0.6 (0.7)), Raynaud’s symptoms (0.6 (0.8) vs 0.9 (0.9)) and disease-related limitations (0.7 (0.7) vs 1.0 (0.9), while their control group counterparts experienced an increase (e.g., Raynaud’s symptoms; 1.0 (1.0) vs 0.8 (0.9)).

In overall, the intervention was highly successful, offering disease-related and overall health benefits to participants.

Lay summary

Systemic sclerosis (SSc) is a rare autoimmune disease characterised by skin fibrosis, affecting internal organs and the veins of those who suffer. Pain and fatigue are two of the most common and important problems faced by people with SSc, being linked with poor overall quality of life. Although a wide range of medications are being widely used to manage both pain and fatigue, these are not very successful.

Knowing that exercise has been useful in clinical populations, on which pain and fatigue has similar origins to SSc, we proposed an exercise-based intervention to support pain and fatigue management.

We recruited 170 people with SSc, across six European countries (UK, Greece, Italy, Denmark, Sweden and Netherlands). All participants were randomly divided into two groups (Group A: exercise and standard care (n=86) and Group B: standard care only (n=84)).

group participants were training twice per week, over a 12-week period, doing high-intensity interval aerobic and upper body resistance training. All participants were assessed 3 times (baseline, intervention completion, 6-months following recruitment) in total. Assessments were mainly focused on condition-related pain and fatigue (which were our main measures of success), quality of life as well as physical and functional fitness.

the end of the intervention, our exercise group participants experienced improvements in relation to their quality of life, feeling less tired and disease-specific pain. More specifically, they experienced improvements in their social, functional and physical wellbeing at a time where our control group participants experienced a deterioration (for example in social and physical wellbeing).

Similarly, our exercise group participants experienced a reduction in pain, breathing problems, Raynaud’s symptoms and disease-related health limitations, while their control group counterparts experienced an increase (for example, in occurrence of Raynaud’s symptoms).

Our participants found the intervention beneficial and enjoyable, looking forward to engage further with physical activity, should they are offered with this opportunity.

Publications

  • Mitropoulos, A., Boström, C., Mattsson, M., Kouidi E., Dimitroulas T., I. E. Liem S., P. M. Vliet Vlieland T., de Vries-Bouwstra J.K., Jacobsen S., Cuomo G., Akil M. & Klonizakis M. Exploring the effects of a combined exercise programme on pain and fatigue outcomes in people with systemic sclerosis: study protocol for a large European multi-centre randomised controlled trial. Trials 23, 962 (2022). https://doi.org/10.1186/s13063-022-06853-1

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  • Anifanti M, Teloudi A, Mitropoulos A, Syrakou N, Pagkopoulou E, Triantafyllidou E, Boström C, Diederichsen LP, Cuomo G, Dimitroulas T, Klonizakis M, Kouidi E. Right Ventricular Morphology and Function after Exercise Training in People with Systemic Sclerosis: A Randomized Controlled Pilot Study. Life (Basel). 2023 Feb 15;13(2):545. doi: 10.3390/life13020545. PMID: 36836902; PMCID: PMC9958927.

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