Clinical trial NCT03238222: Motivating Structured Walking Activity in Intermittent Claudication
Official title: A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Peripheral Vascular Disease
Keywords: Walking
Six-Minute Walk Distance
Illness Perceptions
Theory of Planned Behaviour
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: The Dunhill Medical Trust
First posted: 2017-08-03
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6 Minute Walk Distance
timeFrame: 3 months
Secondary outcomes:
measure: 6 Minute Walk Distance (6MWD)
timeFrame: Baseline and 3 months
measure: Self-reported Maximum Walking Distance
timeFrame: Baseline, 3 and 6 months
measure: Self-Reported Walking Ability
timeFrame: Baseline, 3 and 6 months
measure: Activities of Daily Living
timeFrame: Baseline, 3 and 6 months
measure: Health-Related Quality of Life
timeFrame: Baseline, 3 and 6 months
Other outcomes:
measure: Treatment Cognitions
timeFrame: Baseline, 3 and 6 months
measure: Illness Cognitions
timeFrame: Baseline, 3 and 6 months
measure: Walking Adherence
timeFrame: Baseline, 3 and 6 months
measure: Resource Use
timeFrame: Baseline, 3 and 6 months
measure: Health Related Quality of Life
timeFrame: Baseline, 3 and 6 months
measure: Pain Free Walking Ability
timeFrame: Baseline and 3 months
measure: Maximal Walking Ability
timeFrame: Baseline and 3 months
Locations:
city: Dartford
country: United Kingdom
facility: Dartford and Gravesham NHS Trust (GSTT PIC site)
state: Kent
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
state: Kent
city: Ashford
country: United Kingdom
facility: Ashford & St Peter's NHS Foundation Trust
state: Surrey
city: London
country: United Kingdom
facility: Guy's & St Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Trust (GSTT PIC site)
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal London Hospital, Barts Heatth NHS Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Sanjay Patel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bearne LM, Volkmer B, Peacock J, Sekhon M, Fisher G, Galea Holmes MN, Douiri A, Amirova A, Farran D, Quirke-McFarlane S, Modarai B, Sackley C, Weinman J, Bieles J; MOSAIC Trial Collaboration. Effect of a Home-Based, Walking Exercise Behavior Change Intervention vs Usual Care on Walking in Adults With Peripheral Artery Disease: The MOSAIC Randomized Clinical Trial. JAMA. 2022 Apr 12;327(14):1344-1355. doi: 10.1001/jama.2022.3391.