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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to treatment allocation. Participants are instructed not to disclose their treatment allocation to the outcome assessor during testing.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and older
- •Confirmed SSc diagnosis (ACR/EULAR criteria) for ≥6 months
- •Able to provide informed consent
排除标准
- •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.
研究组 & 干预措施
Partially supervised home-based exercise
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.
干预措施: Home-based exercise programme (Behavioral)
Usual care
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.
干预措施: Usual Care (Other)
结局指标
主要结局
Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L).
时间窗: 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).
次要结局
- Change from baseline in functional performance measured by the 30-second sit-to-stand test (number of repetitions).(Measured at baseline and 6 months)
- Change from baseline in aerobic capacity measured by the 2-minute walk test.(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).(Measured at baseline and 6 months.)
- Change from baseline in balance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest).(Measured at baseline and 6 months.)
- Change from baseline in disease impact measured by the Systemic Sclerosis Impact of Disease (ScleroID).(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).(Measured at baseline, 6 months, and 12 months.)
- Change from baseline in depressive symptoms measured by the Major Depression Inventory (MDI).(Measured at baseline, 6 months, and 12 months.)
- Productivity losses measured by the iMTA Productivity Cost Questionnaire (iPCQ).(Measured at baseline and at 3, 6, 9, and 12 months.)
- Healthcare utilization and medication use measured by the Healthcare Utilization Questionnaire (HUQ).(Measured at baseline and at 3, 6, 9, and 12 months.)