An interventional study of Home-based exercise programme and Usual Care in Systemic Sclerosis (SSc), sponsored by University of Aarhus. Not yet recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
The goal of this randomised controlled trial is to evaluate whether a partially supervised, home-based exercise programme in addition to usual care improves health-related quality of life in adults with systemic sclerosis.
The main questions it aims to answer are:
Researchers will compare the partially supervised, home-based exercise programme plus usual care with usual care alone to determine whether the partially supervised, home-based exercise programme improves health-related quality of life, disease impact, physical function, physical activity, and represents a cost-effective treatment strategy.
Participants will:
Systemic sclerosis (SSc) is a rare autoimmune connective tissue disease associated with substantial impairments in health-related quality of life, physical function, and participation in daily activities. Although exercise is recommended as part of the non-pharmacological management of SSc, the current evidence is based primarily on small, short-term studies, and high-quality randomized controlled trials evaluating the effectiveness and cost-effectiveness of home-based exercise programmes are lacking.
The ScleroStrong trial is an international, multicentre, assessor-blinded, parallel-group randomised controlled trial conducted at Aarhus University Hospital, Odense University Hospital, Copenhagen University Hospital - Rigshospitalet, and the University Hospital of Pisa. A total of 270 adults with systemic sclerosis will be randomised (1:1) to either a partially supervised, home-based exercise programme in addition to usual care or to usual care alone. Clinical effectiveness will be evaluated at 6 months, while the health economic evaluation will be performed over a 12-month follow-up period.
The primary objective is to determine whether a partially supervised, home-based exercise programme improves health-related quality of life compared with usual care. A secondary objective is to evaluate whether the intervention represents a cost-effective treatment strategy from both societal and healthcare perspectives. The study will additionally investigate the effects of the intervention on disease impact, physical function, physical activity, depressive symptoms, adherence, and safety.
The investigators hypothesize that:
A full trial protocol including a statistical analysis plan will be published and made publicly available before completion of the primary analyses. The primary analysis will follow the intention-to-treat principle, with a supplementary per-protocol analysis. Between-group differences will be analysed using mixed-effects regression models including intervention group, follow-up time, and their interaction as fixed effects, while recruitment site and participant will be included as random effects. Cost-effectiveness and cost-utility analyses will estimate incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs) based on healthcare and societal costs and quality-adjusted life years.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 270 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to this arm will receive a 24-week, partially supervised home-based exercise programme in addition to usual care, followed by 28 weeks of self-guided exercise. The programme consists of three weekly exercise sessions including 30 minutes of moderate-intensity walking and three resistance exercises (squat, elastic-band chest press, and elastic-band seated row). Participants will attend six online physiotherapist consultations during the first 24 weeks for exercise instruction, monitoring, progression, and individual adaptation. Exercise progression is based on participants' ability to perform three sets of 10-12 repetitions with acceptable pain and discomfort. Participants will receive instructional videos, exercise equipment (elastic resistance bands), and an exercise diary. The intervention is individually tailored according to disease manifestations, physical function, and exercise tolerance while continuing their usual care.
Behavioral: Home-based exercise programme
Participants allocated to the usual care group will continue to receive the standard care provided by their healthcare providers. Usual care may include pharmacological treatment, routine outpatient follow-up, and access to publicly funded group-based physiotherapy according to national practice. The content and extent of usual care may vary between participants depending on disease manifestations and clinical needs. Participants will continue their current treatments and may receive additional treatments if considered appropriate by their treating healthcare providers.
Other: Usual Care
The intervention is a 24-week, partially supervised home-based exercise programme consisting of three exercise sessions per week, followed by 28 weeks of self-guided exercise. Each session includes 30 minutes of moderate-intensity walking (Borg Rating of Perceived Exertion 14-15) and three progressive resistance exercises targeting major muscle groups (squat, elastic-band chest press, and elastic-band seated row). Resistance exercises are performed in three sets of 10-12 repetitions and individually progressed by increasing resistance or exercise difficulty according to predefined progression criteria. The programme includes six online physiotherapist consultations during the supervised phase. Instructional exercise videos, elastic resistance bands, and an exercise diary are provided to support the home-based exercise programme. The programme is individually tailored according to disease manifestations, physical function, and exercise tolerance.
Usual care consists of standard clinical management provided by the participant's healthcare providers according to local practice and current national recommendations. This may include pharmacological treatment, routine outpatient follow-up, patient education, and referral to publicly funded group-based physiotherapy where appropriate. The content and intensity of usual care are individualized according to disease manifestations, symptoms, and clinical needs and are not standardized by the study protocol.
Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L).
The EQ-5D-5L is a five-dimension, patient-reported outcome measure designed to assess generic health-related quality of life. The descriptive index ranges from -0.757 (worst health state) to 1.000 (best health state), while the EQ visual analogue scale (EQ-VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Measured at baseline, 6 months, and 12 months.
Change from baseline in functional performance measured by the 30-second sit-to-stand test (number of repetitions).
The 30-second sit-to-stand test assesses lower-extremity functional performance. Participants are instructed to stand up from and sit down on a standard chair as many times as possible within 30 seconds without using their arms. The outcome is the total number of completed repetitions, with higher scores indicating better functional performance.
Time frame: Measured at baseline and 6 months
Change from baseline in aerobic capacity measured by the 2-minute walk test.
The 2-minute walk test assesses aerobic capacity and functional walking performance. Participants are instructed to walk as far as possible for 2 minutes along a course of up to 30 metres. The outcome is the total distance walked in metres, with greater distances indicating better aerobic capacity and functional performance.
Time frame: Measured at baseline and 6 months
Change from baseline in upper-body functional strength measured by the 30-second arm curl test (number of repetitions).
The 30-second arm curl test assesses upper-body functional strength. Participants are instructed to perform as many arm curl repetitions as possible within 30 seconds while seated, using their dominant arm and a standardized weight (2 kg for women and 4 kg for men). The outcome is the total number of completed repetitions, with higher scores indicating better upper-body functional strength.
Time frame: Measured at baseline and 6 months.
Change from baseline in balance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest).
The Mini-BESTest assesses dynamic balance and postural control. The test consists of 14 tasks covering anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each task is scored from 0 to 2, resulting in a total score ranging from 0 to 28 points, with higher scores indicating better dynamic balance and postural control.
Time frame: Measured at baseline and 6 months.
Change from baseline in disease impact measured by the Systemic Sclerosis Impact of Disease (ScleroID).
The Systemic Sclerosis Impact of Disease (ScleroID) is a patient-reported outcome measure designed to assess the impact of systemic sclerosis on patients' daily lives. It comprises 10 domains covering Raynaud's phenomenon, hand function, upper and lower gastrointestinal symptoms, pain, fatigue, life, body mobility, breathlessness, and digital ulcers. Item scores are combined using validated domain-specific weights to generate a total score ranging from 0 to 10, with higher scores indicating greater disease impact.
Time frame: Measured at baseline, 6 months, and 12 months.
Change from baseline in physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a patient-reported questionnaire that assesses physical activity performed during the previous 7 days. It records time spent in vigorous-intensity activity, moderate-intensity activity, walking, and sedentary behaviour. Responses are used to calculate physical activity as metabolic equivalent (MET)-minutes per week and to classify participants into low, moderate, or high physical activity categories according to the IPAQ scoring protocol. Higher MET-minutes per week and higher physical activity categories indicate greater levels of physical activity.
Time frame: Measured at baseline, 6 months, and 12 months.
Change from baseline in depressive symptoms measured by the Major Depression Inventory (MDI).
The Major Depression Inventory (MDI) is a patient-reported questionnaire designed to assess depressive symptoms experienced during the previous 2 weeks. The questionnaire consists of 10 items scored on a 6-point scale, resulting in a total score ranging from 0 to 50. Higher scores indicate more severe depressive symptoms.
Time frame: Measured at baseline, 6 months, and 12 months.
Productivity losses measured by the iMTA Productivity Cost Questionnaire (iPCQ).
The iMTA Productivity Cost Questionnaire (iPCQ) is a patient-reported questionnaire that assesses productivity losses due to health problems. It includes three modules measuring productivity losses related to absenteeism (absence from paid work), presenteeism (reduced productivity while at work), and unpaid work. Higher productivity losses indicate a greater impact of health problems on work and daily activities.
Time frame: Measured at baseline and at 3, 6, 9, and 12 months.
Healthcare utilization and medication use measured by the Healthcare Utilization Questionnaire (HUQ).
The Healthcare Utilization Questionnaire (HUQ) is a patient-reported questionnaire designed to assess healthcare utilization and medication use. It collects information on contacts with healthcare providers, hospital services, and prescribed and over-the-counter medication use during the recall period. The questionnaire is used to estimate healthcare resource use for the health economic evaluation.
Time frame: Measured at baseline and at 3, 6, 9, and 12 months.
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs).
Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. During the intervention period, physiotherapists supervising the exercise programme will record any reported or observed AEs and SAEs. In addition, participants will be asked about any AEs and SAEs at the 6- and 12-month follow-up assessments using open-ended questions.
Time frame: Registered continuously during the 24-week intervention and at 6- and 12-month follow-up.
Adherence to the 24-week partially supervised, home-based exercise programme.
Adherence will be assessed using participants' exercise diaries. The number of completed exercise sessions will be divided by the number of planned exercise sessions and multiplied by 100 to calculate adherence as a percentage. An exercise session is considered completed when the participant performs at least 10 minutes of walking and at least one set of each resistance exercise. High adherence is defined as completion of at least 70% of the 72 planned exercise sessions during the 24-week intervention period.
Time frame: Registered by the participants throughout the 24-week intervention period.
Number of participants who withdraw from the study (drop-outs).
The number and proportion of participants who withdraw from the study before completing the 12-month follow-up will be recorded. Reasons for withdrawal will be documented when available.
Time frame: Registered from randomisation to the 12-month follow-up.
Plan to share: Yes — Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available after publication of the trial.
Access criteria: Data access will be reviewed by the author group. Requesters will be required to sign a Data Access Agreement.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
Of 94 non-industry interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 18 months is below that.
Counting every sponsor, half of 100 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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