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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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London, Regno Unito
- Reclutamento
- King's College Hospital NHS Foundation Trust
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London, Regno Unito
- Reclutamento
- Royal Free London NHS Foundation Trust
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London, Regno Unito
- Reclutamento
- Guy's & St Thomas NHS Foundation Trust
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London, Regno Unito
- Reclutamento
- Lewisham and Greenwich NHS Trust (GSTT PIC site)
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London, Regno Unito
- Reclutamento
- St George's University Hospital NHS Foundation Trust
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London, Regno Unito
- Reclutamento
- The Royal London Hospital, Barts Heatth NHS Trust
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Kent
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Dartford, Kent, Regno Unito
- Reclutamento
- Dartford and Gravesham NHS Trust (GSTT PIC site)
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Maidstone, Kent, Regno Unito
- Reclutamento
- Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
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Surrey
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Ashford, Surrey, Regno Unito
- Reclutamento
- Ashford & St Peter's NHS Foundation Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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6 Minute Walk Distance
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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6 Minute Walk Distance (6MWD)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Treatment Cognitions
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Sanjay Patel, Guy's and St Thomas' NHS Foundation Trust
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 17/LO/0568
- R477/0516 (Altro numero di sovvenzione/finanziamento: Dunhill Medical Trust)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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