Motivating Structured Walking Activity in Intermittent Claudication
- Conditions
- Peripheral Arterial DiseaseIntermittent ClaudicationPeripheral Vascular Disease
- Interventions
- Behavioral: MOSAIC
- Registration Number
- NCT03238222
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 192
- ≥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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MOSAIC Treatment MOSAIC 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.
- Primary Outcome Measures
Name Time Method 6 Minute Walk Distance 3 months 6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
- Secondary Outcome Measures
Name Time Method 6 Minute Walk Distance (6MWD) Baseline and 3 months 6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.
Health-Related Quality of Life Baseline, 3 and 6 months Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Self-reported Maximum Walking Distance Baseline, 3 and 6 months Single global item
Self-Reported Walking Ability Baseline, 3 and 6 months Walking Estimated-Limitation Calculated by History (WELCH)
Activities of Daily Living Baseline, 3 and 6 months Nottingham Extended Activities of Daily Living (NEADL)
Trial Locations
- Locations (9)
Dartford and Gravesham NHS Trust (GSTT PIC site)
🇬🇧Dartford, Kent, United Kingdom
Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
🇬🇧Maidstone, Kent, United Kingdom
Ashford & St Peter's NHS Foundation Trust
🇬🇧Ashford, Surrey, United Kingdom
Guy's & St Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
Lewisham and Greenwich NHS Trust (GSTT PIC site)
🇬🇧London, United Kingdom
St George's University Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
The Royal London Hospital, Barts Heatth NHS Trust
🇬🇧London, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom