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NCT Number: NCT07697573

An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study

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.

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Key information

Conditions

Vascular Ehlers Danlos Syndrome Aneurysm Aortic Dissection Behavior Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Disease Attributes Dissection, Blood Vessel Ehlers-Danlos Syndrome Ehlers-Danlos Syndrome, Type IV Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Co-designed exercise-based lifestyle intervention

Behavioral

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 outcomes

  1. Recruitment rate

    Time frame: 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.

  2. Retention rate

    Time frame: 12 weeks

    Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)

  3. Adherence

    Time frame: 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

  4. Data completeness

    Time frame: Baseline and 12 weeks

    Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)

  5. Acceptability

    Time frame: 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

  6. Adverse events and serious adverse events

    Time frame: Throughout the 12-week intervention period

    Number, type and severity of adverse events and serious adverse events, reviewed by the independent Data Safety Committee.

Secondary outcomes

  1. Fatigue

    Time frame: Baseline and 12 weeks

    FACIT-Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue); score range 0-52; higher scores indicate less fatigue (better outcome)

  2. Anxiety and depression

    Time frame: Baseline and 12 weeks

    Hospital Anxiety and Depression Scale (HADS); two subscales (anxiety and depression), each scored 0-21; higher scores indicate greater symptom severity (worse outcome)

  3. Health-related quality of life

    Time frame: Baseline and 12 weeks

    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)

  4. Physical activity

    Time frame: Baseline and 12 weeks

    International Physical Activity Questionnaire - Short Form; reported as MET-minutes per week; higher values indicate greater physical activity

  5. Lower-limb strength and endurance

    Time frame: Baseline and 12 weeks

    30-Second Sit-to-Stand Test; number of full sit-to-stand repetitions completed in 30 seconds; higher counts indicate better lower-limb strength and endurance (better outcome)

  6. Sub-maximal aerobic capacity

    Time frame: Baseline and 12 weeks

    2-Minute Step Test; total number of steps completed in 2 minutes; higher counts indicate better aerobic capacity (better outcome).

  7. Muscle strength

    Time frame: Baseline and 12 weeks

    Hand grip strength via Jamar handheld dynamometer, recorded in kilograms (best of three attempts per hand); higher values indicate greater muscle strength (better outcome)

  8. Functional mobility

    Time frame: Baseline and 12 weeks

    Short Physical Performance Battery (SPPB); composite score 0-12 from balance, 4-metre gait speed, and 5-repetition sit-to-stand; higher scores indicate better lower-extremity function (better outcome)

  9. Orthostatic heart rate response

    Time frame: Baseline and 12 weeks

    Heart rate measured supine and on standing (1, 3, 5 min) to screen for orthostatic intolerance

  10. Orthostatic blood pressure response

    Time frame: Baseline and 12 weeks

    Blood pressure measured supine and on standing (1, 3, 5 min) to screen for orthostatic hypotension.

  11. Microvascular function

    Time frame: Baseline and 12 weeks

    Cutaneous vascular conductance via Laser Speckle Contrast Imaging during local thermal hyperaemia. Expressed as cutaneous vascular conductance (perfusion units/mmHg); higher values indicate greater microvascular reactivity

Study contacts

Contact information is provided by the study sponsor or research team.

Ian Thistlewood

CONTACT

[email protected]

+447939953194

Markos Klonizakis

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Registry information

Official study title

Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods Feasibility Study

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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