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

2026年7月9日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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.
无干预：Usual Care
Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Recruitment rate
大体时间：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
大体时间：12 weeks
Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)
12 weeks
Adherence
大体时间：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
大体时间：Baseline and 12 weeks
Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
Baseline and 12 weeks
Acceptability
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Fatigue
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sheffield Hallam University

调查人员

  • 首席研究员：Markos Klonizakis、Sheffield Hallam University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年3月17日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月9日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRAS361077
  • 26/NE/0025 (其他标识符：REC)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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