Condition category
Circulatory System
Date applied
10/05/2011
Date assigned
04/08/2011
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recent information has suggested that exercise may help people who have suffered from a stroke. Exercise may help to control the levels of glucose in the body and to improve blood flow in different areas of the brain. This may decrease the likelihood of having another stroke by improving the quality of your blood vessels and by decreasing the formation of fatty substances called plaques. Exercise has also been shown to improve functions such as walking and balance. This study will test the effect of exercise on the control of glucose in the body, blood flow in the brain and limb function. Understanding the relationship between exercise, glucose control, blood flow in the brain and limb function is important as it may reduce the risk of further stroke and may improve day to day functions such as walking and balance.

Who can participate?
Men and women aged 50 years or older, who have had a stroke at least six months ago who are able to walk independently with or without a stick for six minutes

What does the study involve?
The study will investigate older adults following stroke caused either by a blockage or bleeding in the brain. Participants will be asked to complete a number of tests like magnetic resonance imaging (MRI), blood tests and functional tests. Participants will then be randomly allocated to either an exercise group where they will complete balance, strengthening and agility exercises three times a week for nineteen weeks, or to a stretching group where they will undertake a home stretching programme for the same period of time. Initial tests will be repeated at the end of the intervention to assess if there has been any change.

What are the possible benefits and risks of participating?
Being more physically active may be beneficial to your glucose control, blood flow in the brain and your limb function and if you continue exercising after the study, this may help in preventing other complications such as heart disease and diabetes. You will have supervised exercise sessions (like a personal trainer) which will teach you about your body, show you how to exercise correctly and help you become more physically fit. Risks include the following. Giving up time to participate has to be considered. There may be a small chance of pulling a muscle during the exercise intervention, but every precaution will be taken to avoid any harm. All the staff involved in the exercise intervention have experience working with people affected by stroke. The participants will have their body composition measured in a device called the Bod Pod. In order to do this accurately participants will be asked to wear their swimwear. Every effort will be made to avoid embarrassment and maintain dignity during this procedure.

Where is the study run from?
The Campus for Ageing and Vitality at Newcastle University (UK)

When is the study starting and how long is it expected to run for?
January 2011 to February 2012

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
1. Dr Michael Trenell (m.i.trenell@ncl.ac.uk)
2. Dr SA Moore (s.a.moore@ncl.ac.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Trenell

ORCID ID

Contact details

MoveLab
4th Floor William Leech Building
Institute of Cellular Medicine
Faculty of Medical Sciences
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 3009
michael.trenell@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SFV1

Study information

Scientific title

The effect of a fitness and mobility exercise programme on glucose control and blood flow in the brain in older adults with chronic stroke

Acronym

Study hypothesis

An exercise an mobility programme improves brain blood flow and glucose control in older adults with chronic stroke.

Ethics approval

1. County Durham and Tees Valley Research and Ethics Committee, 04/01/2010
2. Newcastle upon Tyne Hospitals Trust, 06/04/2010, ref: 09/H0908176

Study design

Single-centre single-blinded randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Stroke

Intervention

1. A fitness and mobility exercise programme based upon the intervention protocol devised by Pang and colleagues (Pang et al., 2005b)
2. The exercise intervention lasts 19 weeks and participants will be asked to attend three times a week for one hour on Mondays, Wednesdays and Fridays at 2pm
3. The exercise programme combines elements of fitness, mobility and balance and has been shown to be an effective and feasible intervention for delivery to stroke survivors in the community (Marigold et al., 2005; Pang et al., 2005a; Eng JJ et al., 2003)
4. Previous studies have established very high levels of compliance with the programme, alongside post intervention improvements in fitness levels, paretic femoral bone mineral density and strength (Marigold DS et al., 2005; Pang et al., 2005b; Eng JJ et al., 2003)
5. Participants will wear a Polar heart rate monitor to assess if they are exercising within the set heart rate ranges required by the exercise protocol
6. The polar heart rate monitors will also be used to capture data on energy expenditure, mean heart rate, minimum heart rate and maximum heart rate during each session
7. The intervention will be run by a physiotherapist and fitness instructor with experience in stroke rehabilitation, cardiac rehabilitation and elderly fitness
8. There will be a minimum of 1 instructor to five participants

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Glucose control (frequently sampled oral glucose tolerance test)
2. Cerebral blood flow via magnetic resonance imaging (MRI)

Secondary outcome measures

1. Cardiorespiratory fitness
2. Body composition
3. Stroke impairment
4. Cognition
5. Endurance speed and balance
6. Physical activity
7. Quality of life

Overall trial start date

01/01/2011

Overall trial end date

03/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 50 years old
2. Diagnosed with a stroke by a stroke physician through computer tomography or magnetic resonance imaging and clinical characteristics at least six months previously
3. Participants are all able to walk for six minutes independently allowing for rests with or without a stick
4. Lives at home
5. Completed all conventional physiotherapy offered by the National Health Service (NHS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. The absolute and relative contraindications to exercise testing as stated by the American Heart Association (Fletcher et al., 2001)
2. Other neurological or medical conditions in addition to stroke which would prevent individuals from participating
3. A diagnosis of diabetes, the presence of pain on walking (>5 on a visual analogue scale of pain)
4. Untreated major depression
5. Cognitive or speech problems limiting understanding of the study (participants were excluded if their Mini Mental Scale Examination (MMSE) was under 25 and if they were unable to follow two stage commands) (Folstein et al. 1975)

Recruitment start date

01/01/2011

Recruitment end date

03/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MoveLab
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Royal Victoria Infirmary, Newcastle (UK)

Sponsor details

c/o Jessica Qian RM & G Manager (NTW CLRN)
Newcastle upon Tyne Hospitals NHS Foundation Trust
Joint Research Office
Level 6
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 5491
Jessica.Qian@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Medical Research Council (ref: G0802536)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Institute of Health Research, Biomedical Research Centre for Ageing & Age Related Disease

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25538152
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26763949

Publication citations

Additional files

Editorial Notes

11/08/2016: Publication reference added. 13/07/2016: Publication reference added. 14/06/2013: The following corrections were made: 1. The overall trial start date has been changed back from 10/05/2010 to 01/01/2011. 2. The overall trial end date has been changed back from 19/10/2011 to 03/02/2012. 26/06/2012: The following changes have been made on the trial record. 1. The overall trial start date has been updated from 01/01/2011 to 10/05/2010. 2. The overall trial end date has been updated from 03/02/2012 to 19/10/2011.