Motivating Structured Walking Activity in Intermittent Claudication

NCT03238222 | Unknown DMC

• 2 other identifiers: 17/LO/0568R477/0516
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 9

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Disease

Keywords

Walking; Six-Minute Walk Distance; Illness Perceptions; Theory of Planned Behaviour

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Distance

  6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.

  3 months

Secondary Outcomes (5)

• 6 Minute Walk Distance (6MWD)

  Baseline and 3 months

• Self-reported Maximum Walking Distance

  Baseline, 3 and 6 months

• Self-Reported Walking Ability

  Baseline, 3 and 6 months

• Activities of Daily Living

  Baseline, 3 and 6 months

• Health-Related Quality of Life

  Baseline, 3 and 6 months

Other Outcomes (7)

• Treatment Cognitions

  Baseline, 3 and 6 months

• Illness Cognitions

  Baseline, 3 and 6 months

• Walking Adherence

  Baseline, 3 and 6 months

Study Arms (2)

MOSAIC Treatment

EXPERIMENTAL

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.

Behavioral: MOSAIC

Usual Care Comparison

NO INTERVENTION

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.

Interventions

MOSAIC BEHAVIORAL

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.

Also known as: Motivating Structured walking Activity in IC

MOSAIC Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• The Dunhill Medical Trust: collaborator

Study Sites (9)

Dartford and Gravesham NHS Trust (GSTT PIC site)

Dartford, Kent, United Kingdom

RECRUITING

Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)

Maidstone, Kent, United Kingdom

RECRUITING

Ashford & St Peter's NHS Foundation Trust

Ashford, Surrey, United Kingdom

RECRUITING

Guy's & St Thomas NHS Foundation Trust

London, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Lewisham and Greenwich NHS Trust (GSTT PIC site)

London, United Kingdom

RECRUITING

Royal Free London NHS Foundation Trust

London, United Kingdom

RECRUITING

St George's University Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

The Royal London Hospital, Barts Heatth NHS Trust

London, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 35412564 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Diseases

Interventions

Mosaicism

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chromosome Aberrations; Mutation; Genetic Variation; Genetic Phenomena

Study Officials

• Sanjay Patel

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie S Bieles, PhD

CONTACT

02078486321; julie.s.bieles@kcl.ac.uk

Lindsay Bearne, PhD

CONTACT

0207 848 6283; lindsay.bearne@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: November 10, 2017
• Primary Completion: November 9, 2020
• Study Completion: January 9, 2021
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

GB (9)