Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Home-based exercise programme: 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: 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 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. 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.

Eligibility

Primary outcome measure(s)

• Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L). — 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).

Trial sites (3)

More University of Aarhus trials in Denmark

Other trials for the same condition