Exercise in People With Systemic Sclerosis

Summary

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.

Conditions

• Systemic Sclerosis

Interventions

OTHER

Exercise programme

12-week exercise programme. The estimated session's duration of 55 minutes. For the prescription of high intensity interval training (HIIT) and the collection of individualised peak power output (PPO) a baseline peak oxygen uptake on an arm crank ergometer will be performed. Each session will consist of 5 minutes warm up performing light to moderate intensity arm cranking (55-65% PPO), 30-minutes' high intensity interval training (HIIT; 30s 100% PPO/ 30s passive recovery) on an arm crank ergometer. The HIIT protocol will be combined with resistance training (RT) lasting for a total of 15 min.The intensity will be at 75-80% of one repetition maximum. Following each exercise session, patients will undertake a 5 min cool-down period.

Sponsors & Collaborators

• Leiden University

  collaborator OTHER

• Rikshospitalet University Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Aristotle University Of Thessaloniki

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• Sheffield Hallam University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2023-09-30

Completion

2024-02-28

Countries

• United Kingdom

Study Locations