Can we successfully deliver and evaluate a physiotherapist-led behaviour-change programme to support walking in people with intermittent claudication? A feasibility and acceptability study

ISRCTN	ISRCTN55465549
DOI	https://doi.org/10.1186/ISRCTN55465549
Secondary identifying numbers	16709

Submission date: 05/06/2014
Registration date: 05/06/2014
Last edited: 22/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Intermittent claudication (IC) is a symptom of leg pain that occurs during walking as a result of restricted blood supply in the arteries of the legs, called peripheral arterial disease (PAD). Despite the discomfort it causes, walking exercise can improve the distance and speed of walking. Uptake and maintenance of walking exercise is poor, and people with IC could benefit from interventions aimed at increasing motivation. A recent small-scale study showed that a psychological intervention was successful in increasing walking compared with usual care. This study aims to determine whether delivery of the intervention by a trained physiotherapist is feasible, check whether this intervention can be given to a wider group of patients at various stages of their disease, and find out about the effect on functional walking test performance.

Who can participate?
Patients with peripheral arterial disease who have symptoms of intermittent claudication.

What does the study involve?
First, you will be asked to visit Kings College London (Guys Campus, London Bridge) for a 90-minute appointment. You will be asked to complete a 6-minute walking test along a flat indoor surface. During the walk, you will be able to stop and rest at any point, to relieve any leg pain or if you are tired. You will then be able to sit and recover while you complete a set of questionnaires that ask about your beliefs about PAD, walking as a treatment, and your diet. Then, you will be given a pedometer, which is a small device you can wear on your waistband and which counts the steps you take. You will be asked to take the pedometer home with you and wear this during the day for the next 6 days. Over the next 2 weeks a physiotherapist will visit you in your home on two separate occasions, to pick up the pedometer and to discuss your beliefs about PAD and to set goals and plans for healthy lifestyle changes. These visits will last 60 minutes and will take place at a time that is convenient for you. The physiotherapist will telephone you after 4 and 8 weeks to see how you are getting on with your goals and to help you address any problems or challenges in achieving your goals. At the end of the study, you will be asked to visit Kings College London for a second appointment where you will repeat the 6-minute walk test, fill out a set of questionnaires and be given a pedometer to take home once again. You will also be given a postage paid envelope that you can return the pedometer in once you are finished wearing it. You may be invited to volunteer and provide feedback on your experience of the intervention by telephone or a face-to-face interview which will take place at Kings College London or your home. The interview will last up to 45 minutes. The audio tapes will be transcribed then destroyed. Direct quotes from the interviews may be used in the write up of the study but these will be anonymised and not able to be traced back to the participant.

What are the possible benefits and risks of participating?
A 6-minute walking test might cause leg pain, tiredness or discomfort. You will be asked to walk at a brisk pace, but will be able to stop and rest at any point during the 6 minutes. Completing questionnaires about your beliefs and health behaviours may be tiring, and may cause you to feel worried or anxious. However, you can choose not to respond to any questions you feel are inappropriate. If you have concerns about any aspect of this study, you may contact the researchers, who will do their best to answer your questions. The physiotherapist visits will provide you with information about PAD and leg pain, and will help you build goals and plans to begin healthy lifestyle changes. By completing the questionnaires, you may learn about your own thoughts and beliefs about PAD and walking as a treatment. The 6-minute walk test will provide information on your walking ability in a safe and secure environment. The information we get from this study will help us to develop a programme that aims to help people with PAD make healthy lifestyle changes.

Where is the study run from?
1. Guys & St Thomas NHS Foundation Trust, UK
2. Kings College Hospital NHS Foundation Trust UK

When is the study starting and how long is it expected to run for?
The study starts in April 2014 and runs until October 2014.

Who is funding the study?
The Dunill Medical Trust (UK).

Who is the main contact?
Melissa N Galea Holmes
Tel: 0207 848 6679
melissa.galeaholmes@kcl.ac.uk

Contact information

Mrs Melissa Galea Holmes
Scientific

Division of Health and Social Care Research
7th Floor
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom

Email	melissa@ccc.ac.uk

Study information

Study design	Feasibility study of a randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of a physiotherapist-led behaviour-change intervention targeting walking in people with intermittent claudication: a feasibility and acceptability study
Study objectives	This feasibility study evaluates 6 criteria: 1. Study retention 2. Compliance with treatment and attention-control protocols 3. Suitability of the proposed outcome measures 4. Variability of primary outcomes for sample size calculation 5. Suitability of proposed methods for evaluating treatment integrity 6. Acceptability and feasibility based on participant experiences of the trial
Ethics approval(s)	NRES Committee North West Greater Manchester West, 18/02/2014, ref: 14/NW/0089
Health condition(s) or problem(s) studied	Intermittent claudication due to peripheral vascular disease.
Intervention	1. Treatment: Brief home-based physiotherapist-led behaviour-change intervention targeting walking activity and using the following behaviour change techniques: social support, information about health consequences, goal setting, problem solving, action planning, self-monitoring, review of goals. Treatment will be delivered in two 60-minute face-to-face sessions by a physiotherapist at participants' home, and two 20 minute telephone follow-up calls. 2. Attention-Control: Two 60-minute home-based face-to-face sessions delivered by a physiotherapist and two 20-minute follow-up calls to match the intervention group. Content will address risk factors for peripheral arterial disease and dietary behaviour.
Intervention type	Behavioural
Primary outcome measure	1. Change in 6-Minute Walk Distance (metres) at 16-week follow-up, measured by a 6-Minute Walk Test; 2. Change in pedometer Step Count (average steps/day) at 16-week follow-up, measured using an Omron Walking Style Pro.
Secondary outcome measures	1. Change in treatment cognitions measured by a Theory of Planned Behaviour Questionnaire at 16-week follow-up 2. Change in illness cognitions measured by the Revised Illness Perceptions Questionnaire at 16-week follow-up 3. Change in self-regulatory processes measured by a modified questionnaire on Action Planning and Action Control at 16-week follow-up
Overall study start date	01/02/2014
Completion date	01/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 24; UK Sample Size: 24
Total final enrolment	24
Key inclusion criteria	1. Age ≥18 years 2. Peripheral arterial disease and intermittent claudication as established by a vascular clinician, and based on arterial palpitation, or results of angiography, computed tomography, or MRI scanning.
Key exclusion criteria	1. Presence of a condition for which it is unadvisable to increase walking (e.g., unstable angina) 2. Endovascular treatment or bypass surgery scheduled in the upcoming 4 months 3. Comorbidity which limits walking to a greater extent than intermittent claudication 4. Inability or refusal to provide informed consent 5. Inability to comprehend English
Date of first enrolment	03/04/2014
Date of final enrolment	01/10/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Guy's & St Thomas' NHS Foundation Trust

Westminster Bridge Road
London
SE1 7EH
United Kingdom

King’s College Hospital NHS Foundation Trust

Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

King's College London
Hospital/treatment centre

Guy's Campus
London
SE1 1UL
England
United Kingdom

Website	http://www.guysandstthomas.nhs.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

The Dunill Medical Trust (UK); Grant Codes: RTF09/0110

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration 2016 results published in thesis: https://kclpure.kcl.ac.uk/portal/files/51618152/2016_Galea_Holmes_Melissa_N_0934448_ethesis.pdf
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2019	22/11/2019	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

22/11/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
3. A link to a thesis has been added to the publication and dissemination plan.
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.