Systemic Sclerosis (SSc)ScleroStrongNCT07840430
Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis
A study testing Home-based exercise programme in people with Systemic Sclerosis (SSc), run by University of Aarhus at 3 sites in Denmark.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Home-based exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
- Able to provide informed consent
Who cannot join
- Evidence that the patient cannot participate in a self-guided exercise programme or adhere to study procedures (e.g. due to cognitive impairment)
- Patient cannot understand or speak Danish (for Aarhus University Hospital, Odense University Hospital, and Copenhagen University Hospital - Rigshospitalet) or Italian (for University Hospital of Pisa).
- Patient lacks an email address to receive electronic questionnaires.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Department of Clinical Medicine - The Section for Rheumatology, Aarhus University Hospital
Aarhus, 8000
Esben U Næser, Clin. Ass. Prof, esben.naeser@clin.au.dk
Department for Rheumatology and Spine Diseases, Copenhagen University Hospital - Rigshospitalet
Glostrup Municipality, 2600
Christoffer T Nielsen, Clin. Ass. Prof, +4535458244, christoffer.tandrup.nielsen.01@regionh.dk
Department of Rheumatology, Odense University Hospital
Odense, 5000
Katrine H Gade, MD, Consultant
About this study
Official title: Home-based Exercise Compared to Usual Care for Improving Health-related Quality of Life in Systemic Sclerosis - a Multicentre Randomised Controlled Trial (the ScleroStrong Trial)
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:
Read more
- Does a partially supervised, home-based exercise programme improve health-related quality of life, measured by the EQ-5D-5L, compared with usual care alone after 6 months?
- Is the partially supervised, home-based exercise programme cost-effective compared with usual care over a 12-month period?
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:
- Be randomly assigned to either the partially supervised, home-based exercise programme plus usual care or usual care alone.
- Complete questionnaires at baseline and after 3, 6, 9, and 12 months.
- Undergo physical function assessments at baseline and after 6 months.
- If allocated to the intervention group, perform a 24-week home-based exercise programme consisting of three weekly sessions of aerobic and resistance exercise, supported by six online physiotherapist consultations, followed by 28 weeks of self-guided exercise.
- Complete follow-up assessments of healthcare utilization, productivity, adherence, and adverse events throughout the 12-month study period.
Read the detailed description
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 partially supervised, home-based exercise programme will result in greater improvements in health-related quality of life after 6 months compared with usual care.
- The partially supervised, home-based exercise programme will be cost-effective and cost-utility favourable compared with usual care over a 12-month follow-up period.
- Participants allocated to the partially supervised, home-based exercise programme will demonstrate greater improvements in disease impact, physical function, and physical activity than participants receiving usual care.
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.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Home-based exercise programme, Usual Care
- Keywords
- Systemic Sclerosis, SSc, Exercise Therapy, Health economic evaluation, Scleroderma
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise programmeBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Partially supervised home-based exercise | Experimental | 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. Receives: Behavioral: Home-based exercise programme |
| Usual care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measured at baseline, 6 months, and 12 months.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured at baseline and at 3, 6, 9, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Pisa University Hospital
- Responsible party
- Sponsor
- Investigators
- Jesper L Jensen, MSc, Principal investigator, Aarhus University HospitalInger Mechlenburg, Professor, Study director, Aarhus University Hospital and Aarhus UniversityEsben U Næser, Clin. Ass. Prof., Study director, Aarhus University Hospital and Aarhus UniversityJohn K Brincks, Senior Ass. Prof., Study director, VIA University CollegeMarco Di Battista, Study director, Pisa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840430
- Sponsor's protocol ID
- ScleroStrong
- Acronym
- ScleroStrong
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Exercise Compared to Usual Care for Improving Health-related Quality of Life in Systemic Sclerosis - a Multicentre Randomised Controlled Trial (the ScleroStrong Trial)
- ClinicalTrials.gov ID
- NCT07840430
- Acronym / sponsor ID
- ScleroStrong / ScleroStrong
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- Systemic Sclerosis, SSc, Exercise Therapy, Health economic evaluation, Scleroderma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Pisa University Hospital
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a partially supervised, home-based exercise programme improve health-related quality of life, measured by the EQ-5D-5L, compared with usual care alone after 6 months?
- Is the partially supervised, home-based exercise programme cost-effective compared with usual care over a 12-month period?
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:
- Be randomly assigned to either the partially supervised, home-based exercise programme plus usual care or usual care alone.
- Complete questionnaires at baseline and after 3, 6, 9, and 12 months.
- Undergo physical function assessments at baseline and after 6 months.
- If allocated to the intervention group, perform a 24-week home-based exercise programme consisting of three weekly sessions of aerobic and resistance exercise, supported by six online physiotherapist consultations, followed by 28 weeks of self-guided exercise.
- Complete follow-up assessments of healthcare utilization, productivity, adherence, and adverse events throughout the 12-month study period.
Detailed description
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 partially supervised, home-based exercise programme will result in greater improvements in health-related quality of life after 6 months compared with usual care.
- The partially supervised, home-based exercise programme will be cost-effective and cost-utility favourable compared with usual care over a 12-month follow-up period.
- Participants allocated to the partially supervised, home-based exercise programme will demonstrate greater improvements in disease impact, physical function, and physical activity than participants receiving usual care.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially supervised home-based exercise | Experimental | Behavioral: Home-based exercise programmeParticipants 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. |
| Usual care | Active comparator | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and older
- Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Evidence that the patient cannot participate in a self-guided exercise programme or adhere to study procedures (e.g. due to cognitive impairment)
- Patient cannot understand or speak Danish (for Aarhus University Hospital, Odense University Hospital, and Copenhagen University Hospital - Rigshospitalet) or Italian (for University Hospital of Pisa).
- Patient lacks an email address to receive electronic questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exercise programmeThe 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. | Behavioural | Partially supervised home-based exercise |
| Usual CareUsual 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. | Other | Usual care |
Primary outcome
Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L).
Time frame: Measured at baseline, 6 months, and 12 months.
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).
9 secondary outcomes
Change from baseline in functional performance measured by the 30-second sit-to-stand test (number of repetitions).
Time frame: Measured at baseline and 6 months
Change from baseline in aerobic capacity measured by the 2-minute walk test.
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).
Time frame: Measured at baseline and 6 months.
Change from baseline in balance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest).
Time frame: Measured at baseline and 6 months.
Change from baseline in disease impact measured by the Systemic Sclerosis Impact of Disease (ScleroID).
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).
Time frame: Measured at baseline, 6 months, and 12 months.
Change from baseline in depressive symptoms measured by the Major Depression Inventory (MDI).
Time frame: Measured at baseline, 6 months, and 12 months.
Productivity losses measured by the iMTA Productivity Cost Questionnaire (iPCQ).
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).
Time frame: Measured at baseline and at 3, 6, 9, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesper L Jensen, MSc principal investigator
Aarhus University Hospital
Inger Mechlenburg, Professor study director
Aarhus University Hospital and Aarhus University
Esben U Næser, Clin. Ass. Prof. study director
Aarhus University Hospital and Aarhus University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise programme in people with Systemic Sclerosis (SSc), run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper L Jensen, MSc (+4560608684, jesperjensen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L). (time frame: Measured at baseline, 6 months, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.