Exploring the effects of a combined exercise programme on pain and fatigue outcomes in patients with systemic sclerosis: A large multi-centre randomised controlled trial

Recruiting

Conditions: scleroderma
systemic sclerosis
10003816

Registration Number: NL-OMON53458

Lead Sponsor: Sheffield Hallam University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 31

Inclusion Criteria

1) A diagnosis of Systemic Sclerosis according to the 2013 ACR/EULAR criteria
experiencing Raynaud's phenomenon;
2) Age over 18 years old; and
3) ability to perform the prescribed exercise regime.
4) be able and willing to give written informed consent prior to entry in the
study.

Exclusion Criteria

1) Advanced pulmonary involvement (e.g., pulmonary arterial hypertension);
2) New York Heart Association class 3 or 4;
3) Active disease/exacerbations such as active digital ulcers;
4) A recent change in patient*s medical treatment (either type or dose of drug
targeting vascular function), following a period of three months the interested
patients will be able to take part; and
5) Active disease-related exacerbations (e.g., active digital ulcers).
6) Current pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain is measured with the visual analogue scale (VAS) included in Scleroderma<br /><br>Health Assessment Questionnaire (SHAQ; VAS-SHAQ) and fatigue with the<br /><br>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mood will be assessed with the Centre for Epidemiologic Studies-Depression<br /><br>Scale (CES-D). In addition, a microvascular assessment by means of nailfold<br /><br>capillaroscopy (NC) is done, aerobic capacity is measured by a Peak Oxygen<br /><br>Uptake test on an arm crank ergometer and hand and arm strength are assessed by<br /><br>a hand held dynamometer and the biceps curl test, respectively. Added<br /><br>questionnaire in LUMC 22/03/2023: Illness Perceptions Questionnaire-Revised<br /><br>(IPQ-R).</p><br>