ClinicalTrials.gov record NCT07697573

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationUnited Kingdom
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This mixed‑methods project co-designs a tailored, low‑intensity exercise and lifestyle programme with people who have vascular Ehlers‑Danlos syndrome (vEDS), then pilots it in a 12‑week randomized feasibility trial. Adults with vEDS are randomly assigned to the remotely supervised exercise programme or to usual care. The study evaluates whether the intervention and trial procedures are safe, acceptable, and practical, and collects exploratory measures of physical function and well‑being.

What it is studying. Whether a co-produced, individually tailored 12-week low‑intensity, low‑impact exercise and lifestyle programme can be delivered and evaluated safely and acceptably for adults with vascular Ehlers‑Danlos syndrome compared with usual care, and whether it is practical to run a larger trial. The study also collects preliminary measures of physical function, fatigue, mood, quality of life, physical activity, and microvascular function.

What the researchers hope to learn. To determine if the intervention and trial procedures are feasible and safe; to estimate recruitment, retention, adherence, and data completeness; to assess acceptability; and to collect exploratory data on physical function, fatigue, anxiety/depression, quality of life, physical activity, and microvascular function to inform a future full‑scale trial.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Co-designed exercise-based lifestyle intervention

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomised to either a 12-week, individually tailored, remotely supervised low-intensity/low-impact exercise and lifestyle programme with weekly remote monitoring, or to continue usual care with no study intervention. They attend assessments at baseline and after 12 weeks that include questionnaires (fatigue, anxiety/depression, quality of life), physical tests (30-second sit-to-stand, 2-minute step, hand-grip, mobility/gait tests), blood pressure and standing heart-rate checks, and a non-invasive skin microvascular test. Participants wear an ActiGraph device to monitor step count and heart rate and record completion of prescribed exercise sessions; adverse events are recorded throughout. Some participants may take part in a post-intervention interview about their experience.

How the study is structured. A mixed‑methods study where early phases (interviews and focus groups) co-produce the intervention. The registered component is a 12‑week randomized, parallel, unmasked feasibility trial: participants are randomly assigned to the remotely supervised exercise programme or to continue usual care. Feasibility outcomes (recruitment, retention, adherence, data completeness, acceptability, safety) are measured, and participants complete exploratory physical and questionnaire measures before and after 12 weeks. Post‑intervention interviews explore participant experiences.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United Kingdom. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on vascular Ehlers-Danlos syndrome

Clinical trials6 trials listed for vascular Ehlers-Danlos syndromeEvery trial the registry lists for vascular Ehlers-Danlos syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in vascular Ehlers-Danlos syndrome researchLatest monthly update: September 2026. Includes: Care coordination. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 1, 2027 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Study completion
Mar 17, 2028 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Jul 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Sheffield Hallam University
Principal investigator
Markos Klonizakis, Professor
Sheffield Hallam University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

randomised
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
usual care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrolment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Phase 1
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Phase 2
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Phase 3
A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Phase 4
A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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