Intermittent Claudication, Peripheral Arterial Disease, Peripheral Vascular Disease
Conditions
Keywords
Walking, Six-Minute Walk Distance, Illness Perceptions, Theory of Planned Behaviour
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.
Interventions
BEHAVIORALMOSAIC
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.
Sponsors
King's College London
The Dunhill Medical Trust
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| Health-Related Quality of Life | Baseline, 3 and 6 months | Vascular Quality of Life Questionnaire-6 (VascuQol-6) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Cognitions | Baseline, 3 and 6 months | Theory of Planned Behaviour Questionnaire |
| Maximal Walking Ability | Baseline and 3 months | The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test |
| Illness Cognitions | Baseline, 3 and 6 months | Brief Illness Perceptions Questionnaire (BIPQ) |
| Walking Adherence | Baseline, 3 and 6 months | Exercise Adherence Rating Scale |
| Resource Use | Baseline, 3 and 6 months | Client Service Receipt Inventory |
| Health Related Quality of Life | Baseline, 3 and 6 months | Euroqol- 5D-5L |
| Pain Free Walking Ability | Baseline and 3 months | Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test |
Countries
United Kingdom
Contacts
Primary ContactJulie S Bieles, PhD
Backup ContactLindsay Bearne, PhD
Outcome results
None listed