Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)
A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial
Peripheral arterial disease can cause leg pain or discomfort (called intermittent claudication (IC)), which limits the ability to walk and carry out everyday activities. Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge to begin and then continue. The aim of this study is to investigate if a physiotherapist-led, behaviour change treatment effects walking in people with IC. The treatment is designed to build an understanding of IC and walking exercise and help individuals develop strategies to increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC. All participants will visit King's College London or their local hospital to complete two short walking tests and answer questionnaires about their daily activities, beliefs about their symptoms and treatment, quality of life and the costs of having IC.
Participants will then be randomly assigned to receive either the new treatment or continue with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at the participant's home or local hospital) and two 20-minute telephone calls with a physiotherapist who will discuss participants' understanding and beliefs about IC, walking and help participants to set goals and plans to increase walking over 12 weeks. Participants will be provided with a step counter (pedometer) and walking record.
After 12 weeks, all participants will attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires will be completed by all participants after 6 months (by post or electronically). Some participants will be invited to provide feedback on their experience of the treatment and trial by telephone or a face-to-face interview with a researcher.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Julie S Bieles, PhD
- 電話番号：02078486321
- メール：julie.s.bieles@kcl.ac.uk
研究連絡先のバックアップ
- 名前：Lindsay Bearne, PhD
- 電話番号：0207 848 6283
- メール：lindsay.bearne@kcl.ac.uk
研究場所
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London、イギリス
- 募集
- King's College Hospital NHS Foundation Trust
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London、イギリス
- 募集
- Royal Free London NHS Foundation Trust
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London、イギリス
- 募集
- Guy's & St Thomas NHS Foundation Trust
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London、イギリス
- 募集
- Lewisham and Greenwich NHS Trust (GSTT PIC site)
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London、イギリス
- 募集
- St George's University Hospital NHS Foundation Trust
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London、イギリス
- 募集
- The Royal London Hospital, Barts Heatth NHS Trust
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Kent
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Dartford、Kent、イギリス
- 募集
- Dartford and Gravesham NHS Trust (GSTT PIC site)
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Maidstone、Kent、イギリス
- 募集
- Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
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Surrey
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Ashford、Surrey、イギリス
- 募集
- Ashford & St Peter's NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- ≥50 years of age;
- established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence or clinician reported diagnosis) and IC (presence of symptoms reported on the San Diego Claudication Questionnaire)
- able to participate in MOSAIC
- able and willing to provide informed consent
Exclusion Criteria:
- Unstable IC (self-reported change in symptoms during previous 3 months)
- walking >90 minutes/week (reported on Brief International Physical Activity Questionnaire
- contraindications to walking exercise (e.g., unstable angina) confirmed by their vascular specialist
- have completed any prescribed supervised exercise sessions in the previous 6 months or been offered prescribed exercise sessions in the next 6 months.
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：MOSAIC Treatment
MOSAIC treatment plus Usual NHS Care.
MOSAIC treatment comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) with a trained physiotherapist.
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MOSAIC comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) delivered at a convenient time and location of participant's choice (local NHS Trust or participant's home).
All sessions are delivered by a trained Band 6/7 physiotherapist.
All participants randomized to receive MOSAIC will be provided with a pedometer and a patient manual which will include information on intermittent claudication, risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.
他の名前：
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介入なし：Usual Care Comparison
Usual NHS care for people with intermittent claudication typically consists of an initial assessment, drug therapy and simple advice to walk provided by a vascular specialist and delivered in the vascular outpatient clinic.
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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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6 Minute Walk Distance
時間枠：3 months
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6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
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3 months
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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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6 Minute Walk Distance (6MWD)
時間枠：Baseline and 3 months
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6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
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Baseline and 3 months
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Self-reported Maximum Walking Distance
時間枠：Baseline, 3 and 6 months
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Single global item
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Baseline, 3 and 6 months
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Self-Reported Walking Ability
時間枠：Baseline, 3 and 6 months
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Walking Estimated-Limitation Calculated by History (WELCH)
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Baseline, 3 and 6 months
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Activities of Daily Living
時間枠：Baseline, 3 and 6 months
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Nottingham Extended Activities of Daily Living (NEADL)
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Baseline, 3 and 6 months
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Health-Related Quality of Life
時間枠：Baseline, 3 and 6 months
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Vascular Quality of Life Questionnaire-6 (VascuQol-6)
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Baseline, 3 and 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment Cognitions
時間枠：Baseline, 3 and 6 months
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Theory of Planned Behaviour Questionnaire
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Baseline, 3 and 6 months
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Illness Cognitions
時間枠：Baseline, 3 and 6 months
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Brief Illness Perceptions Questionnaire (BIPQ)
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Baseline, 3 and 6 months
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Walking Adherence
時間枠：Baseline, 3 and 6 months
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Exercise Adherence Rating Scale
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Baseline, 3 and 6 months
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Resource Use
時間枠：Baseline, 3 and 6 months
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Client Service Receipt Inventory
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Baseline, 3 and 6 months
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Health Related Quality of Life
時間枠：Baseline, 3 and 6 months
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Euroqol- 5D-5L
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Baseline, 3 and 6 months
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Pain Free Walking Ability
時間枠：Baseline and 3 months
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Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test
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Baseline and 3 months
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Maximal Walking Ability
時間枠：Baseline and 3 months
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The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test
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Baseline and 3 months
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協力者と研究者
捜査官
- 主任研究者：Sanjay Patel、Guy's and St Thomas' NHS Foundation Trust
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 17/LO/0568
- R477/0516 (その他の助成金/資金番号：Dunhill Medical Trust)
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?
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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