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

9. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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 inngripen: Usual Care
Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sheffield Hallam University

Etterforskere

  • Hovedetterforsker: Markos Klonizakis, Sheffield Hallam University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

17. mars 2028

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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