Condition category
Circulatory System
Date applied
09/11/2014
Date assigned
12/12/2014
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stroke is a serious, life-threatening medical condition that happens when the blood supply to a part of the brain is cut off, usually due to a blood clot or haemorrhage. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs, but includes paralysis, muscle weakness and speech problems. A stroke can also have an impact on the sufferers emotions and can lead to anxiety, depression and personality changes. Here, we want to find out the best way to help people who have recently had a stroke to improve their level of fitness with a particular focus on their cardiovascular fitness (health of heart and lungs). Research has shown that stroke patients can improve their cardiovascular fitness by doing intensive programmes of activity (cardiac rehabilitation) which has also been shown to reduce their risk of further strokes. There are, however, gaps in the research about what is the best form of cardiovascular training, particularly for stroke patients. Our project aims aim to fill those gaps in the research. Opinions on cardiac rehabilitation and attitudes to exercise will be collected from stroke patients, carers and health professionals. This information will then be used to determine what should be included in a cardiac rehabilitation programme. A study to investigate how beneficial cardiac rehabilitation is for people who have had a stroke will then be developed. Stroke patients, carers and therapists will be invited to take part in interviews and focus groups to discuss issues related to cardiac rehabilitation. Stroke survivors will also be involved in a study to determine the best way to test cardiovascular fitness and participate in cardiac rehabilitation.

Who can participate?
Adults who have had a stroke in the last one to 4 months and able to walk at least 10 metres.

What does the study involve?
The study is made up of four parts.
Part I: Participants are interviewed in their own homes where they discuss attitudes to exercise before and after stroke and attitudes to participating in cardiac rehabilitation.
Part II: Participants are invited to take part in one focus group in their work environment. Attitudes to exercise and cardiac rehabilitation are again discussed.
Part III: Participants are brought into the UHL NHS Trust for up to four hours, where they complete three different measures of cardiovascular fitness; the six minute walk test, the shuttle walk test and the VO2 peak test measured on a static bike.
Part IV: After undergoing an initial assessment, including collecting information on how frequently they fall and their activity level (measured by an accelerometer) participants attend the cardiac rehabilitation programme twice a week for six weeks. At the end of the six weeks they undergo the assessment again. They are also interviewed about their experiences.

What are the possible benefits and risks of participating?
There may be no benefits to taking part. However, it has been shown that people who have a stroke can improve their physical fitness doing various forms of exercise. Taking part in cardiac rehabilitation may improve their physical fitness and may also reduce their risk of subsequent strokes through helping them identify and establish lifestyle changes. They will be able to discuss their exercise and their future healthy lifestyle with a chartered physiotherapist and specialist nurses and psychologists. The results of this trial will also help to establish if a larger trial can be run to compare cardiac rehabilitation to other forms of cardiovascular fitness training. Cardiac fitness tests are regularly used for heart disease and stroke patients without any complications. Cardiac rehabilitation programs are used for people who have heart disease and stroke patients have completed other forms of cardiovascular training without complications.

Where is the study run from?
1. University of Leicester (UK)
2. UHL NHS Trust (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

Physiotherapy Department
Maurice Shock Building
University of Leicester
Leicester
LE1 7RH
United Kingdom
0116 252 3305
njc36@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

151210

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 sub-acute stroke patients

Acronym

Study hypothesis

As this is a feasibility study the aim is to explore service user and health professionals’ attitudes, determine outcome measures and establish an intervention to inform a definitive trial that will determine the effectiveness of adapted CR for sub-acute stroke patients

Ethics approval

NRES Committee East Midlands - Northampton, 11/8/2014, ref. 14/EM/1067

Study design

Single site feasibility study using a mixed method design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information sheets available on request

Condition

Sub-acute stroke patients

Intervention

This feasibility study will be undertaken in 4 parts.
Part I - participant interviews exploring attitudes to exercise and cardiac rehabilitation before and after stroke.
Part II - health professional focus groups discussing cardiac rehabilitation and attitudes to exercise before and after stroke.
Part III - a validity study comparing the assessment of cardiovascular fitness of stroke participants using three different measures; the six minute walk test, the shuttle walk test and the VO2 peak test measured on a static bike
Part VI - participants undergo baseline assessments and then attend cardiac rehabilitation programme twice a week for six weeks. At the end of the six weeks baseline measures are repeated and participants are interviewed about their experiences.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Cardiovascular fitness

Secondary outcome measures

N/A

Overall trial start date

01/09/2014

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Participants will be sub-acute stroke and TIA patients (one week to four months post stroke)
2. Aged over 18 years
3. Able to speak English
4. Able to walk at least 10 metres and their carers

Healthcare professionals working in the field of stroke care or cardiac rehabilitation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Part I - 20, Part II - 32 (recruitment 25/09/2014 - 28/02/2015). Part III 40 (recruitment 1/03/2015 - 31/12/2015) Part IV - 30. (recruitment 01/01/2016 - 31/08/2016)

Participant exclusion criteria

1. Heart disease class III and upwards (NYHA Classification), angina on exercise,
2. Class C or D exercise risk (ACSM)
3. Uncontrolled arrhythmias and poorly controlled hypertension
4. Significant cardio-respiratory, locomotor or psychiatric problems that limit participation in exercise programmes

Recruitment start date

25/09/2014

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Physiotherapy Department Maurice Shock Building
Leicester
LE1 7RH
United Kingdom

Sponsor information

Organisation

UHL NHS Trust

Sponsor details

Gwendolen Road
Leicester
LE5 4QF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.leicestershospitals.nhs.uk/

Funders

Funder type

Charity

Funder name

The Stroke Association (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

/08

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to publish Part I and Part II by the end of 2015 and present at the UK Stroke Forum in 2015
Plan to publish Part III and Part IV by end of 2016

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes