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

9. juli 2026 opdateret af: Markos Klonizakis, Sheffield Hallam University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
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.
Adfærdsmæssigt: 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.
Ingen indgriben: Usual Care
Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: 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.
From study start through completion of recruitment, up to 12 months
Retention rate
Tidsramme: 12 weeks
Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)
12 weeks
Adherence
Tidsramme: 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
Over the 12-week intervention period
Data completeness
Tidsramme: Baseline and 12 weeks
Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
Baseline and 12 weeks
Acceptability
Tidsramme: 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
12 weeks
Adverse events and serious adverse events
Tidsramme: Throughout the 12-week intervention period
Number, type and severity of adverse events and serious adverse events, reviewed by the independent Data Safety Committee.
Throughout the 12-week intervention period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fatigue
Tidsramme: 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)
Baseline and 12 weeks
Anxiety and depression
Tidsramme: 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)
Baseline and 12 weeks
Health-related quality of life
Tidsramme: 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)
Baseline and 12 weeks
Physical activity
Tidsramme: Baseline and 12 weeks
International Physical Activity Questionnaire - Short Form; reported as MET-minutes per week; higher values indicate greater physical activity
Baseline and 12 weeks
Lower-limb strength and endurance
Tidsramme: 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)
Baseline and 12 weeks
Sub-maximal aerobic capacity
Tidsramme: Baseline and 12 weeks
2-Minute Step Test; total number of steps completed in 2 minutes; higher counts indicate better aerobic capacity (better outcome).
Baseline and 12 weeks
Muscle strength
Tidsramme: 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)
Baseline and 12 weeks
Functional mobility
Tidsramme: 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)
Baseline and 12 weeks
Orthostatic heart rate response
Tidsramme: Baseline and 12 weeks
Heart rate measured supine and on standing (1, 3, 5 min) to screen for orthostatic intolerance
Baseline and 12 weeks
Orthostatic blood pressure response
Tidsramme: Baseline and 12 weeks
Blood pressure measured supine and on standing (1, 3, 5 min) to screen for orthostatic hypotension.
Baseline and 12 weeks
Microvascular function
Tidsramme: 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
Baseline and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sheffield Hallam University

Efterforskere

  • Ledende efterforsker: Markos Klonizakis, Sheffield Hallam University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

17. marts 2028

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRAS361077
  • 26/NE/0025 (Anden identifikator: REC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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