Reducing sedentary behaviour after stroke

Plain English Summary

Background and study aims
Time spent in sedentary behaviour (sitting/lying down) has recently emerged as an important topic. Too much time spent in sedentary behaviours is linked with ill health and mortality. This seems to be independent of physical activity – a short burst of activity such as an exercise class will not offset the detrimental health effects of many hours of sitting. Survivors of stroke are among the most sedentary individuals in the population, spending up to 80% of their waking day sitting or lying down. Interventions to reduce sitting time have enormous potential, would be low cost and may be more achievable than a structured exercise programme, particularly in stroke survivors afraid of another stroke or falling. This study's focus is on reducing sitting time in survivors of stroke in their own homes once they have been discharged from the hospital and therapy services. However, to achieve this the researchers feel it is important that stroke survivors are appropriately informed and supported in reducing sedentary behaviour from the time of their stroke, learning techniques which they can continue at home when no longer in receipt of therapy. Through a review of the evidence, observations of practice and joint work between stroke survivors, their carers, and healthcare professionals, ideas and action plans for reducing time spent sitting/lying (an intervention) have been developed. The initial intervention was tested and optimised in three services. The aim of this pragmatic pilot cluster Randomised Controlled Trial (cRCT) with embedded process and economic evaluations is to undertake a
preliminary exploration of the developed intervention.

Who can participate?
Stroke in-patients aged 16 years or over at the time of stroke, requiring manual contact of no more than one person to stand to prevent falling with planned discharge into the community.

What does the study involve?
The intervention will be delivered by NHS stroke services across the UK. NHS stroke services randomly allocated to the intervention group will be trained to deliver the intervention alongside current practice, whilst those allocated to the control group will continue to deliver current practice. The study aims to recruit 300-400 stroke survivors in 15 NHS stroke services. Patients with a planned discharge home will be recruited by researchers based on the referring
stroke units. Outcomes will be assessed at 6, 12 and 24 months after stroke survivors’ recruitment and registration to the trial. The primary endpoint is the ability in extended activities of daily living measured using the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months post-registration. A key secondary outcome is sedentary behaviour in total sitting time at 12 months (measured by the activity monitor activPAL); other secondary outcomes are
listed in the outcome section of this record. Endpoint analyses will be exploratory and provide preliminary estimates of the intervention effect.

A parallel and embedded process evaluation will explore and understand the implementation of the developed intervention and how it is experienced and understood by providers and recipients. This will include a range of methods including documentary analysis, non-participant observation and semi-structured interviews with a sample of trial participants and intervention providers.

What are the possible benefits and risks of participating?
The intervention is a quality improvement initiative which aims to reduce sedentary behaviour in stroke survivors. Patients admitted to stroke services allocated to the intervention may therefore benefit from the intervention. Aside from the possible effects of the intervention, participating in the study would bring about no direct or immediate benefit to stroke survivors, carers or stroke service managers, therapists or other multidisciplinary team members. However, the aim of the study is to gather data to inform the development and preliminary evaluation of an intervention to reduce sedentary behaviours for people who have had a stroke and in the future, therefore all participants would be making a contribution to these efforts to reduce sedentary behaviour after stroke and improve outcomes. There is some evidence that interview participants may derive some benefit from talking about their experiences.

For stroke survivor participants, there is a risk that some may find wearing the activity monitors burdensome and/or may experience a skin reaction/itchiness or discomfort depending on the method of attachment. Colleagues have undertaken large studies with older people where the ActivPAL activity monitor was successfully used. The researchers will follow their standard operating procedures. Completion of the paper-based outcome assessments may be time
consuming, but they have been tested in a feasibility study and the researchers will provide advice and help where required.

Some of the questions in the semi-structured interviews (conducted as part of the embedded process evaluation) may cover topics that the interviewee may find distressing. They will be made aware of this before consenting to take part. At the time of the interview, it will be made clear that participants may pause and/or terminate the interview at any time. Non-participant observations of the provision of care/therapy provided to individual patients (also part of the process evaluation) may be perceived as intrusive by staff and/or patients and caregivers. All participants would be made aware before giving consent of the ways in which researchers would carry out their observations. That is, research fellows will seek verbal permission to observe on each and every occasion (in addition to written consent for more focused observations of individual sessions), locate themselves so as not to hinder the conduct of the care provision/therapy session, not speak during this time unless requested to do so by the patient, carer or staff member, have due regard for privacy and dignity and maintain confidentiality at all times. No episodes of personal care would be observed. Research fellows will cease observations if requested to do so by patients, their carers, and/or stroke service staff.

Where is the study run from?
Bradford Teaching Hospitals NHS Foundation Trust and the University of Leeds (UK)

When is the study starting and how long is it expected to run for?
December 2019 to December 2024

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Anne Forster
a.forster@leeds.ac.uk
recreate@leeds.ac.uk

Study website

Contact information

Prof Anne Forster
Scientific

Chief Investigator
Academic Unit of Ageing and Stroke Research
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

ORCID ID	0000-0001-7466-4414
Phone	+44 (0)1274 38 3406
Email	a.forster@leeds.ac.uk

Mrs Florence Day
Scientific

Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom

ORCID ID	0000-0003-0306-5558
Phone	+44 (0)113 343 1672
Email	recreate@leeds.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

26/11/2024: Study contact replaced.
24/10/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. The overall study end date was changed from 01/10/2024 to 01/12/2024.
3. The intention to publish date was changed from 31/01/2025 to 31/03/2025.
21/08/2024: The following changes were made to the trial record:
1. The overall end date was changed from 01/08/2024 to 01/10/2024.
2. The intention to publish date was changed from 31/12/2024 to 31/01/2025.
3. The plain English summary was updated to reflect these changes.
18/04/2024: The overall study end date was changed from 30/04/2024 to 01/08/2024.
14/09/2023: Publication reference added.
31/07/2023: Publication reference added.
13/06/2023: The participant level data sharing statement was added.
27/04/2023: Internal review.
25/04/2023: The following changes have been made and the plain English summary updated accordingly:
1. The scientific title has been changed from "A multicentre cluster randomised controlled trial evaluating the clinical and cost-effectiveness of an intervention to reduce sedentary behaviour in stroke survivors incorporating an internal pilot phase and embedded process evaluation" to "A multicentre pilot cluster randomised controlled trial evaluating an intervention to reduce sedentary behaviour in stroke survivors incorporating an embedded process evaluation".
2. The study hypothesis has been changed.
3. The interventions have been changed.
4. The primary outcome measure has been changed.
5. The secondary outcome measures have been changed.
6. The participant inclusion criteria have been changed.
7. The target number of participants has been changed from "Planned Sample Size: 1156; UK Sample Size: 1156" to "We originally planned a large multi-centre RCT with 34 stroke services each recruiting 34 participants. However, site recruitment was slower than expected due to issues related to the
COVID-19 pandemic. Therefore, we are conducting a large external pilot trial. We aim to recruit 300-400 participants across 15 stroke services. As the study will not have a formal power calculation and effectiveness will not be evaluated, all analyses will be of an exploratory nature.".
8. The participant exclusion criteria have been changed.
02/02/2023: A contact was removed.
20/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 30/04/2023.
2. The overall end date was changed from 31/12/2024 to 30/04/2024.
3. The intention to publish date was changed from 31/12/2025 to 31/12/2024.
4. The plain English summary was updated to reflect these changes.
15/03/2022: The recruitment end date was changed from 31/03/2022 to 31/12/2022.
17/02/2020: Trial's existence confirmed by the NIHR.