Condition category
Circulatory System
Date applied
22/10/2014
Date assigned
22/10/2014
Last edited
17/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

17/02/2016: Plain English summary added.