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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ian Thistlewood
- 電話番号：+447939953194
- メール：i.thistlewood@shu.ac.uk
研究連絡先のバックアップ
- 名前：Markos Klonizakis
- メール：m.klonizakis@shu.ac.uk
研究場所
-
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South Yorkshire
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Sheffield、South Yorkshire、イギリス、S10 2BP
- Sheffield Hallam University
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コンタクト：
- Markos Klonizakis
- メール：m.klonizakis@shu.ac.uk
-
コンタクト：
- Ian Thistlewood
- 電話番号：07939953194
- メール：i.thistlewood@shu.ac.uk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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介入なし：Usual Care
Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate
時間枠：From study start through completion of recruitment, up to 12 months
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Proportion of eligible participants who consent to take part, expressed as a monthly recruitment rate.
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From study start through completion of recruitment, up to 12 months
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Retention rate
時間枠：12 weeks
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Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)
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12 weeks
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Adherence
時間枠：Over the 12-week intervention period
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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
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Over the 12-week intervention period
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Data completeness
時間枠：Baseline and 12 weeks
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Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)
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Baseline and 12 weeks
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Acceptability
時間枠：12 weeks
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Acceptability assessed via a questionnaire informed by the Theoretical Framework of Acceptability (seven constructs, 5-point Likert scale), supplemented by post-intervention interviews
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12 weeks
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Adverse events and serious adverse events
時間枠：Throughout the 12-week intervention period
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Number, type and severity of adverse events and serious adverse events, reviewed by the independent Data Safety Committee.
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Throughout the 12-week intervention period
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fatigue
時間枠：Baseline and 12 weeks
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FACIT-Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue); score range 0-52; higher scores indicate less fatigue (better outcome)
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Baseline and 12 weeks
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Anxiety and depression
時間枠：Baseline and 12 weeks
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Hospital Anxiety and Depression Scale (HADS); two subscales (anxiety and depression), each scored 0-21; higher scores indicate greater symptom severity (worse outcome)
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Baseline and 12 weeks
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Health-related quality of life
時間枠：Baseline and 12 weeks
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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)
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Baseline and 12 weeks
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Physical activity
時間枠：Baseline and 12 weeks
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International Physical Activity Questionnaire - Short Form; reported as MET-minutes per week; higher values indicate greater physical activity
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Baseline and 12 weeks
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Lower-limb strength and endurance
時間枠：Baseline and 12 weeks
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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)
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Baseline and 12 weeks
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Sub-maximal aerobic capacity
時間枠：Baseline and 12 weeks
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2-Minute Step Test; total number of steps completed in 2 minutes; higher counts indicate better aerobic capacity (better outcome).
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Baseline and 12 weeks
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Muscle strength
時間枠：Baseline and 12 weeks
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Hand grip strength via Jamar handheld dynamometer, recorded in kilograms (best of three attempts per hand); higher values indicate greater muscle strength (better outcome)
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Baseline and 12 weeks
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Functional mobility
時間枠：Baseline and 12 weeks
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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)
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Baseline and 12 weeks
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Orthostatic heart rate response
時間枠：Baseline and 12 weeks
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Heart rate measured supine and on standing (1, 3, 5 min) to screen for orthostatic intolerance
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Baseline and 12 weeks
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Orthostatic blood pressure response
時間枠：Baseline and 12 weeks
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Blood pressure measured supine and on standing (1, 3, 5 min) to screen for orthostatic hypotension.
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Baseline and 12 weeks
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Microvascular function
時間枠：Baseline and 12 weeks
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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
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Baseline and 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Markos Klonizakis、Sheffield Hallam University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年3月1日
一次修了 (推定)
2027年10月1日
研究の完了 (推定)
2028年3月17日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年7月9日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月9日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRAS361077
- 26/NE/0025 (その他の識別子：REC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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