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.
Adults aged 18 years or older
Confirmed diagnosis of vascular Ehlers-Danlos syndrome (vEDS)
Living in the UK
Able to provide informed consent
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Pregnancy at enrolment (participants who become pregnant during the intervention are withdrawn from the exercise component but may continue follow-up data collection if they wish)
Parallel
Co-designed exercise-based lifestyle intervention
BehavioralA 12-week individually tailored exercise-based lifestyle programme, co-produced with people with vEDS, delivered remotely with supervision and weekly monitoring. Comprises low-intensity, low-impact aerobic and functional activity progressed to individual capacity, with behavioural support to encourage sustained physical activity.
Recruitment rate
Proportion of eligible participants who consent to take part, expressed as a monthly recruitment rate.
Retention rate
Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)
Adherence
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
Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
Fatigue
FACIT-Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue); score range 0-52; higher scores indicate less fatigue (better outcome)
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS); two subscales (anxiety and depression), each scored 0-21; higher scores indicate greater symptom severity (worse outcome)
Health-related quality of life
EQ-5D-5L; index value ranging from below 0 to 1, where 1 = full health and higher = better; includes a 0-100 visual analogue scale (higher = better health)
Physical activity
International Physical Activity Questionnaire - Short Form; reported as MET-minutes per week; higher values indicate greater physical activity
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