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| [ ...Back to search results ] | [ Print-friendly version ] |
| The effect of exercise on brain blood flow and metabolism in stroke survivors |
| ISRCTN | ISRCTN41026907 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of exercise on brain blood flow and metabolism in stroke survivors |
| 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 | N/A |
| Serial number at source | SFV1 |
| Study hypothesis | An exercise an mobility programme improves brain blood flow and glucose control in older adults with chronic stroke |
| Lay summary | Lay summary under review |
| Ethics approval |
County Durham and Tees Valley Research and Ethics Committee, 4 January 2010
Newcastle upon Tyne Hospitals Trust gave approval for the research to be conducted within the trust on 06/04/2010 ref: 09/H0908176 |
| Study design | Single centre, single blinded, randomised controlled study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - 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) |
| Participants - 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) |
| Anticipated start date | 01/01/2011 |
| Anticipated end date | 03/02/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 42 |
| Interventions |
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 |
| Primary outcome measure(s) |
1. Glucose control (frequently sampled oral glucose tolerance test)
2. Cerebral blood flow via Magnetic resonance imaging (MRI) |
| Secondary outcome measure(s) |
1. Cardiorespiratory fitness
2. Body Composition 3. Stroke Impairment 4. Cognition 5. Endurance speed and balance 6. Physical Activity 7. Quality of Life |
| Sources of funding |
1. Medical Research Council (ref: G0802536)
2. National Institute of Health Research, Biomedical Research Centre for Ageing & Age Related Disease |
| Trial website | |
| Publications | |
| Contact name | Dr Michael Trenell |
| Address |
MoveLab
4th Floor William Leech Building Institute of Cellular Medicine Faculty of Medical Sciences Newcastle University |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE2 4HH |
| Country | United Kingdom |
| Tel | +44 (0)191 222 3009 |
| michael.trenell@ncl.ac.uk | |
| Sponsor | Royal Victoria Infirmary, Newcastle (UK) |
| Address |
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 |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 4LP |
| Country | United Kingdom |
| Tel | +44 (0)191 282 5491 |
| Fax | +44 (0)191 282 4524 |
| Jessica.Qian@nuth.nhs.uk | |
| Date applied | 10/05/2011 |
| Last edited | 07/11/2011 |
| Date ISRCTN assigned | 04/08/2011 |
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