A feasibility study to identify attitudes, determine outcome measures and develop an intervention to inform a definitive trial that will determine the effectiveness of adapted cardiac rehabilitation for subacute stroke patients

ISRCTN	ISRCTN65957980
DOI	https://doi.org/10.1186/ISRCTN65957980
Secondary identifying numbers	17359

Submission date: 22/10/2014
Registration date: 22/10/2014
Last edited: 21/05/2024

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
A stroke is a serious condition that occurs when the blood supply to part of the brain is cut off. The aim of this study is to determine the best way to support people who have recently had a stroke to improve their fitness, particularly the health of their heart and lungs (cardiovascular fitness). The information from this study will be used to design a larger study to investigate how effective cardiac rehabilitation is for people post stroke.

Who can participate?
Patients aged over 18 who have had a stroke

What does the study involve?
Participants attend a cardiac rehabilitation programme, consisting of a warm up, exercise training and cool down, two times a week for six weeks. Patients’, carers’ and health professionals’ opinions of cardiac rehabilitation and attitudes to exercise following stroke are explored through interviews and focus groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Leicester Royal Infirmary (UK)

When is the study starting and how long is it expected to run for?
September 2014 to August 2017

Who is funding the study?
The Stroke Association (UK)

Who is the main contact?
Nicola Clague-Baker
njc36@le.ac.uk

Contact information

Mrs Nicola Clague-Baker
Scientific

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Email	njc36@le.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Not specified
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
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 feasibility study to identify attitudes, determine outcome measures and develop an intervention to inform a definitive trial that will determine the effectiveness of adapted cardiac rehabilitation for subacute stroke patients
Study acronym	Cardiac Rehab and Stroke
Study objectives	The broad aim of this study is to determine the best way to support people who have recently had a stroke to improve their fitness particularly the health of their heart and lungs (cardiovascular fitness). More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=17359
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Topic: Stroke; Subtopic: Rehabilitation; Disease: In hospital study, Community study
Intervention	Subjects will attend a modified (informed by phase I and II) CR programme and is likely to include a modified warm up, functional exercise training and cool down, two times a week for six weeks.
Intervention type	Behavioural
Primary outcome measure	Effectiveness of adapted cardiac rehabilitation for subacute stroke patients
Secondary outcome measures	Not provided at time of registration
Overall study start date	19/09/2014
Completion date	31/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 902; UK Sample Size: 90
Key inclusion criteria	1. They will be aged over 18 years of age. 2. They will have suffered from a stroke or Transient Ischaemic Attack (TIA) resulting in mild to moderate disability (NIHSS < 15). This means that they could have visual problems, facial palsy, movement problems in their arm and leg, uncoordinated movement and sensory problems. 3. They will be in the subacute phase of recovery, that is, at least one week after their stroke or TIA up to four months post stroke or TIA. 4. They will not have receptive communication or cognitive deficits, this means they can fully understand and consent to the trial. 5. They will be able to walk 10 metres, with help of another person or walking aid if necessary.
Key exclusion criteria	All Parts: Cannotgive informed consent and do not speak English. Part III (Validity study) and Part IV (Cohort study): Heart disease class III and upwards (NYHA Classification), angina on exercise, Class C or D exercise risk (ACSM), uncontrolled arrhythmias and poorly controlled hypertension.
Date of first enrolment	19/09/2014
Date of final enrolment	31/08/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leicester Royal Infirmary

Leicester
LE1 5WW
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom

"ROR"	https://ror.org/02fha3693

Funders

Funder type

Charity

The Stroke Association (UK); Grant Codes: TSA 2013/08

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
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	accelerometry results	01/06/2020	17/12/2020	Yes	No
Results article	Qualitative focus group results of staff attitudes to cardiac rehabilitation for stroke survivors	15/05/2024	21/05/2024	Yes	No

Editorial Notes

21/05/2024: Publication reference added.
17/12/2020: Publication reference added.
17/02/2016: Plain English summary added.