Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Nicola Clague-Baker
ORCID ID
Contact details
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
-
njc36@le.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17359
Study information
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
Acronym
Cardiac Rehab and Stroke
Study hypothesis
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
Not provided at time of registration
Study design
Non-randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Effectiveness of adapted cardiac rehabilitation for subacute stroke patients
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/09/2014
Overall trial end date
31/08/2017
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 902; UK Sample Size: 90
Participant 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.
Recruitment start date
19/09/2014
Recruitment end date
31/08/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Funders
Funder type
Charity
Funder name
The Stroke Association (UK); Grant Codes: TSA 2013/08
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary