An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Co-designed exercise-based lifestyle intervention.
- Who it may be relevant to
- Registry conditions: Vascular Ehlers Danlos Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods Feasibility Study
Overview
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.
Detailed description
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.
Interventions
- Behavioral Co-designed exercise-based lifestyle intervention
A 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.
Primary outcome measures
- Recruitment rate [Time frame: From study start through completion of recruitment, up to 12 months]
- Retention rate [Time frame: 12 weeks]
- Adherence [Time frame: Over the 12-week intervention period]
- Data completeness [Time frame: Baseline and 12 weeks]
- Acceptability [Time frame: 12 weeks]
- Adverse events and serious adverse events [Time frame: Throughout the 12-week intervention period]
Secondary outcome measures (11)
- Fatigue [Time frame: Baseline and 12 weeks]
- Anxiety and depression [Time frame: Baseline and 12 weeks]
- Health-related quality of life [Time frame: Baseline and 12 weeks]
- Physical activity [Time frame: Baseline and 12 weeks]
- Lower-limb strength and endurance [Time frame: Baseline and 12 weeks]
- Sub-maximal aerobic capacity [Time frame: Baseline and 12 weeks]
- Muscle strength [Time frame: Baseline and 12 weeks]
- Functional mobility [Time frame: Baseline and 12 weeks]
- Orthostatic heart rate response [Time frame: Baseline and 12 weeks]
- Orthostatic blood pressure response [Time frame: Baseline and 12 weeks]
- Microvascular function [Time frame: Baseline and 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- Sheffield Hallam University — Sheffield
Identifiers
NCT: NCT07697573 · IRAS361077 · 26/NE/0025