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. 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? 2. 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.
Adults 18 years and older
Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
Able to provide informed consent
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.
Parallel
Home-based exercise programme
BehavioralThe 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
Other interventionUsual 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).
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.
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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Pisa University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
