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

NCT07697573 | Not Yet Recruiting DMC

• 2 other identifiers: IRAS36107726/NE/0025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Ehlers Danlos Syndrome

Keywords

vEDS; COL3A1; physical activity; exercise; feasibility study; rare disease; connective tissue disorder

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Proportion of eligible participants who consent to take part, expressed as a monthly recruitment rate.

  From study start through completion of recruitment, up to 12 months

• Retention rate

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

  12 weeks

• 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

  Over the 12-week intervention period

• Data completeness

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

  Baseline and 12 weeks

• Acceptability

  Acceptability assessed via a questionnaire informed by the Theoretical Framework of Acceptability (seven constructs, 5-point Likert scale), supplemented by post-intervention interviews

  12 weeks

• Adverse events and serious adverse events

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

  Throughout the 12-week intervention period

Secondary Outcomes (11)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Co-designed exercise-based lifestyle intervention

Usual Care

NO INTERVENTION

Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BP, United Kingdom

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome, Type IV; Motor Activity; Rare Diseases; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Markos Klonizakis

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Thistlewood

CONTACT

+447939953194; i.thistlewood@shu.ac.uk

Markos Klonizakis

CONTACT

m.klonizakis@shu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)