Vascular Ehlers Danlos SyndromeNCT07697573
An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study
A study testing Co-designed exercise-based lifestyle intervention in people with Vascular Ehlers Danlos Syndrome, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Ehlers Danlos Syndrome
- What is being tested?
- Co-designed exercise-based lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2027to 17 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Pregnancy at enrolment (participants who become pregnant during the intervention are withdrawn from the exercise component but may continue follow-up data collection if they wish)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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Markos Klonizakis contact
United Kingdom1 site
Sheffield Hallam University
Sheffield, South Yorkshire, S10 2BP
Ian Thistlewood, 07939953194, i.thistlewood@shu.ac.uk
Markos Klonizakis, m.klonizakis@shu.ac.uk
About this study
Official title: Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods 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.
Read the 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.
- Conditions
- Vascular Ehlers Danlos Syndrome
- Being tested
- Co-designed exercise-based lifestyle intervention
- Keywords
- vEDS, COL3A1, physical activity, exercise, feasibility study, rare disease, connective tissue disorder
- Medical subject headings
- Ehlers-Danlos Syndrome, Type IV, Motor Activity, Rare Diseases, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-designed exercise-based lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of eligible participants who consent to take part, expressed as a monthly recruitment rate.
Measured: 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%)
Measured: 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
Measured: Over the 12-week intervention period
Data completeness
Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
Measured: 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
Measured: 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.
Measured: Throughout the 12-week intervention period
Secondary outcomes (11)
Fatigue
FACIT-Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue); score range 0-52; higher scores indicate less fatigue (better outcome)
Measured: Baseline and 12 weeks
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)
Measured: Baseline and 12 weeks
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)
Measured: Baseline and 12 weeks
Physical activity
International Physical Activity Questionnaire - Short Form; reported as MET-minutes per week; higher values indicate greater physical activity
Measured: Baseline and 12 weeks
Lower-limb strength and endurance
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)
Measured: Baseline and 12 weeks
Sub-maximal aerobic capacity
2-Minute Step Test; total number of steps completed in 2 minutes; higher counts indicate better aerobic capacity (better outcome).
Measured: Baseline and 12 weeks
Muscle strength
Hand grip strength via Jamar handheld dynamometer, recorded in kilograms (best of three attempts per hand); higher values indicate greater muscle strength (better outcome)
Measured: Baseline and 12 weeks
Functional mobility
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)
Measured: Baseline and 12 weeks
Orthostatic heart rate response
Heart rate measured supine and on standing (1, 3, 5 min) to screen for orthostatic intolerance
Measured: Baseline and 12 weeks
Orthostatic blood pressure response
Blood pressure measured supine and on standing (1, 3, 5 min) to screen for orthostatic hypotension.
Measured: Baseline and 12 weeks
Microvascular function
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
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Ehlers Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markos Klonizakis, Sheffield Hallam University
- Investigators
- Markos Klonizakis, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697573
- Sponsor's protocol ID
- IRAS361077
- Other IDs
- 26/NE/0025
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small feasibility study not powered for efficacy. Individual participant data will not be shared. Sheffield Hallam University is the Data Controller; data are pseudonymised, stored securely, and retained in line with UK GDPR and institutional policy. Aggregate findings will be disseminated through open-access publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT07697573
- Acronym / sponsor ID
- IRAS361077
- Conditions
- Vascular Ehlers Danlos Syndrome
- Keywords
- vEDS, COL3A1, physical activity, exercise, feasibility study, rare disease, connective tissue disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Co-designed exercise-based lifestyle interventionParticipants 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. |
| Usual Care | No intervention | –Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-designed exercise-based lifestyle interventionA 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. | Behavioural | Intervention |
Primary outcome
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.
Retention rate
Time frame: 12 weeks
Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)
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
Data completeness
Time frame: Baseline and 12 weeks
Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
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
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. This is a small feasibility study not powered for efficacy. Individual participant data will not be shared. Sheffield Hallam University is the Data Controller; data are pseudonymised, stored securely, and retained in line with UK GDPR and institutional policy. Aggregate findings will be disseminated through open-access publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markos Klonizakis contact
Markos Klonizakis principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-designed exercise-based lifestyle intervention in people with Vascular Ehlers Danlos Syndrome, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Thistlewood (+447939953194, i.thistlewood@shu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From study start through completion of recruitment, up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.