To assess the effect of a previously-established, supervised 12-week combined (aerobic and resistance training) exercise programme on pain and fatigue as compared to no exercise.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain is measured with the visual analogue scale (VAS) included in Scleroderma
Health Assessment Questionnaire (SHAQ; VAS-SHAQ) and fatigue with the
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Secondary outcome
Mood will be assessed with the Centre for Epidemiologic Studies-Depression
Scale (CES-D). In addition, a microvascular assessment by means of nailfold
capillaroscopy (NC) is done, aerobic capacity is measured by a Peak Oxygen
Uptake test on an arm crank ergometer and hand and arm strength are assessed by
a hand held dynamometer and the biceps curl test, respectively. Added
questionnaire in LUMC 22/03/2023: Illness Perceptions Questionnaire-Revised
(IPQ-R).
Background 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 program on pain and fatigue in people with SSc
have not been explored.
Study objective
To assess the effect of a previously-established, supervised 12-week combined
(aerobic and resistance training) exercise programme on pain and fatigue as
compared to no exercise.
Study design
Multi-centre, randomized controlled clinical trial.
Intervention
A 12-week exercise programme (aerobic and resistance training) twice per week
(5 minutes warm up, 30-minutes' high intensity interval training on an arm
crank ergometer combined with resistance training (RT) lasting for a total of
15 min, 5 min cool-down period). Each session will be delivered as a one-to-one
supervised session by a qualified health care professional (e.g., clinical
exercise physiologist/physical therapist with experience in SSc).
Study burden and risks
All participants in this trial will be screened for any contra-indication for
exercise therapy by the researchers in close collaboration with the treating
rheumatologist before inclusion The screening is done according to a protocol
that was used in a previous RCT on multidisciplinary team care including
exercise therapy that was executed in the LUMC (P16.259). After randomization,
patients in the control arm will be treated as usual by their rheumatologist,
whereas participants from the experimental arm will receive a 12-week exercise
therapy program. The burden of the participants will be minimized to the time
necessary for completing the assessments (3 visits, baseline, 3 and 6 months,
1.5 - 2 hours per visit), and for those in the experimental arm 24 treatment
sessions of 60 minutes over 12 weeks.
Howard Street 1
Sheffield S1 1WB
GB
Howard Street 1
Sheffield S1 1WB
GB
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05234671 |
| CCMO | NL79999.058.22 |