Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Vascular Ehlers-Danlos syndrome (vEDS) is a rare, life-threatening connective tissue disorder. People with vEDS have often been advised to limit physical activity, yet the safety and feasibility of structured exercise in this group is poorly understood. This study works with people with vEDS, their families and clinicians to co-design a safe, tailored physical activity programme, then tests it in a 12-week randomised feasibility study comparing the programme with usual care. The aim is to find out whether the intervention and the trial procedures are safe, acceptable and practical, in order to inform a future full-scale trial. Outcomes focus on recruitment, retention, adherence, acceptability and safety, alongside exploratory measures of physical function, quality of life and microvascular health.
详细描述
This is a mixed-methods feasibility study delivered across four phases. Phase 1 uses qualitative interviews with people with vEDS, family members and clinicians to understand experiences of physical activity and decision-making under uncertain clinical guidance. Phase 2 uses co-production focus groups to design the exercise-based lifestyle intervention. Phase 3 is a 12-week randomised feasibility trial in which adults with vEDS are randomised to the co-produced intervention or to usual care, assessing feasibility outcomes (recruitment, retention, adherence, data completeness, acceptability and safety) and exploratory clinical measures. Phase 4 uses post-intervention interviews to explore participant experiences and refine the intervention. The registered trial corresponds to the Phase 3 randomised feasibility component; the qualitative phases provide the development and evaluation context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 aged 18 years or older
- •Confirmed diagnosis of vascular Ehlers-Danlos syndrome (vEDS)
- •Living in the UK
- •Able to provide informed consent
- •Medically stable, defined as: no arterial dissection, rupture, or other major vEDS-related vascular event within the preceding 6 months; no recent hospitalisation for vEDS complications; and blood pressure considered controlled by their treating clinician
- •Medical clearance from their treating clinician
- •Not pregnant at the time of enrolment
排除标准
- •Major vEDS-related vascular event (arterial dissection or rupture) within the previous 6 months
- •Recent hospitalisation for vEDS complications
- •Blood pressure not controlled by treating clinician
- •Pregnancy at enrolment (participants who become pregnant during the intervention are withdrawn from the exercise component but may continue follow-up data collection if they wish)
- •Unable to provide informed consent
研究组 & 干预措施
Intervention
Participants receive a 12-week co-produced, remotely supervised, low-intensity and low-impact exercise-based lifestyle intervention, tailored to individual capacity, with weekly remote monitoring.
干预措施: Co-designed exercise-based lifestyle intervention (Behavioral)
Usual Care
Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.
结局指标
主要结局
Recruitment rate
时间窗: From study start through completion of recruitment, up to 12 months
Proportion of eligible participants who consent to take part, expressed as a monthly recruitment rate.
Retention rate
时间窗: 12 weeks
Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)
Adherence
时间窗: Over the 12-week intervention period
Proportion of prescribed exercise sessions completed (target ≥60%), assessed by session completion records and device-based monitoring (step count and heart rate via ActiGraph accelerometer
Data completeness
时间窗: Baseline and 12 weeks
Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
Acceptability
时间窗: 12 weeks
Acceptability assessed via a questionnaire informed by the Theoretical Framework of Acceptability (seven constructs, 5-point Likert scale), supplemented by post-intervention interviews
Adverse events and serious adverse events
时间窗: Throughout the 12-week intervention period
Number, type and severity of adverse events and serious adverse events, reviewed by the independent Data Safety Committee.
次要结局
- Fatigue(Baseline and 12 weeks)
- Anxiety and depression(Baseline and 12 weeks)
- Health-related quality of life(Baseline and 12 weeks)
- Physical activity(Baseline and 12 weeks)
- Lower-limb strength and endurance(Baseline and 12 weeks)
- Sub-maximal aerobic capacity(Baseline and 12 weeks)
- Muscle strength(Baseline and 12 weeks)
- Functional mobility(Baseline and 12 weeks)
- Orthostatic heart rate response(Baseline and 12 weeks)
- Orthostatic blood pressure response(Baseline and 12 weeks)
- Microvascular function(Baseline and 12 weeks)
研究者
Markos Klonizakis
Professor
Sheffield Hallam University