Exercise in People With Systemic Sclerosis

NCT05234671 | Completed

• 1 other identifier: ER35485474
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Pain Assessment (Overall Pain)

  Overall pain will be assessed using the visual analogue scale (VAS) included in scleroderma health assessment questionnaire (SHAQ; VAS-SHAQ). VAS-SHAQ is consisted of a 15-cm which is converted to a continuous scale from 0 to 3 (1cm = 0.2 points on the VAS). For the VAS-SHAQ scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.

  3-month follow up

• Pain Assessment (Overall Pain)

  Overall pain will be assessed using the visual analogue scale (VAS) included in scleroderma health assessment questionnaire (SHAQ; VAS-SHAQ). VAS-SHAQ is consisted of a 15-cm which is converted to a continuous scale from 0 to 3 (1cm = 0.2 points on the VAS). For the VAS-SHAQ scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.

  6-month follow up

• Pain Assessment (Digital Pain)

  Digital pain will be assessed using a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The pain VAS will be comprised of a vertical line, usually 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 100). For the digital VAS scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.

  3-month follow up

• Pain Assessment (Digital Pain)

  Digital pain will be assessed using a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The pain VAS will be comprised of a vertical line, usually 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 100). For the digital VAS scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.

  6-month follow up

• Fatigue Assessment

  Fatigue in people with SSc will be assessed using the functional assessment of chronic illness therapy-fatigue (FACIT-F) which has also been utilised in studies assessing fatigue in people with SSc. Participants will be requested to self-complete this 40-item questionnaire which will assess fatigue and its impact on daily activities and function. FACIT-F is formatted in a Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). All items contribute to the sum score with equal weight. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.

  3-month follow up

• Fatigue Assessment

  Fatigue in people with SSc will be assessed using the functional assessment of chronic illness therapy-fatigue (FACIT-F) which has also been utilised in studies assessing fatigue in people with SSc. Participants will be requested to self-complete this 40-item questionnaire which will assess fatigue and its impact on daily activities and function. FACIT-F is formatted in a Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). All items contribute to the sum score with equal weight. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.

  6-month follow up

Secondary Outcomes (12)

• Quality of life questionnaire

  3-month follow up

• Quality of life questionnaire

  6-month follow up

• Depression scale questionnaire

  3-month follow up

• Depression scale questionnaire

  6-month follow up

• Microvascular assessment

  3-month follow up

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group will perform a supervised combined (e.g., aerobic and resistance training) 12-week exercise programme, twice per week adjunct to the patient's standard care.

Other: Exercise programme

Control group

NO INTERVENTION

The control group will not perform the exercise programme and will receive only the standard care.

Interventions

Exercise programme OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of Systemic Sclerosis according to the 2013 ACR/EULAR criteria experiencing Raynaud's phenomenon
• Age over 18 years old
• Ability to perform the prescribed exercise regime

You may not qualify if:

• Active disease-related exacerbations (e.g., active digital ulcers)
• Change of medical treatment (I.e., medical treatment which is related with the vascular function and blood flow such as calcium channel blockers and vasodilators) within the last 3 months (however, potential participants will be able to take part following that period)
• Advanced pulmonary involvement (e.g., pulmonary arterial hypertension)
• New York Heart Association class 3 or 4
• Inability to exercise
• Current pregnancy

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Leiden University: collaborator
• Rikshospitalet University Hospital: collaborator
• Karolinska Institutet: collaborator
• Aristotle University Of Thessaloniki: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

Sheffield Hallam University

Sheffield, S10 2BP, United Kingdom

Location

Related Publications (2)

• Mitropoulos A, Jensen KY, Kouidi E, Bostrom C, Cuomo G, Diederichsen LP, Mattsson M, Hoekstra EM, De Vries-Bouwstra J, Dimitroulas T, Akil M, Jacobsen S, Klonizakis M; IMPACT-SSc CONSORTIUM. High-intensity interval and resistance training programme improves pain and fatigue outcomes in people with systemic sclerosis: a European multicentre randomised controlled trial. RMD Open. 2025 Nov 11;11(4):e005946. doi: 10.1136/rmdopen-2025-005946.

  PMID: 41219127 DERIVED

• Mitropoulos A, Bostrom C, Mattsson M, Kouidi E, Dimitroulas T, Liem SIE, Vlieland TPMV, de Vries-Bouwstra JK, 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. 2022 Nov 28;23(1):962. doi: 10.1186/s13063-022-06853-1.

  PMID: 36443836 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 10, 2022
• Study Start: September 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: February 28, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)