The effective of a combined intervention in stroke survivors with vascular cognitive impairment
| ISRCTN | ISRCTN16009172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16009172 |
| Protocol serial number | B2017-020-06 |
| Sponsor | Department of Neurology of First People’s Hospital |
| Funder | Department of neurology of Baoshan branch of Shanghai First People’s Hospital |
- Submission date
- 17/04/2018
- Registration date
- 24/07/2018
- Last edited
- 02/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Cognitive deficits are a common problem after a stroke. There is a high risk of patients developing vascular cognitive impairment - a decline in thinking abilities caused by damage to the brain's blood vessels. If intervention is not undertaken as early as possible, this can develop into dementia. Physical exercise and cognitive training may reduce cognitive impairment in older adults. The aim of this study is to investigate the effect of a combined intervention of physical exercise and cognitive training on the cognitive function of stroke survivors with vascular cognitive impairment.
Who can participate?
Patients aged over 18 who have had a stroke within the last 6 months and have vascular cognitive impairment
What does the study involve?
Participants are randomly allocated to one of four groups to receive either physical exercise, cognitive training, both, or usual treatment. They receive training for about 50-60 minutes per day, 3 days per week for 12 weeks. At the start, 8 weeks and 6 months, participants undergo four cognitive tasks that assess their cognitive function. The participants from the usual treatment group also receive the intervention when the study is completed.
What are the possible benefits and risks of participating?
All participants have an opportunity to receive the training, and they may benefit from decreased cognitive impairment. There are no risks of physical injury or harm. Increased anxiety and pain may be experienced during the training sessions but this will be comparable to what is encountered in real life crisis situations in the medical profession.
Where is the study run from?
Medical Rehabilitation Center of Shanghai General Hospital (China)
When is the study starting and how long is it expected to run for?
February 2017 to January 2018
Who is funding the study?
Department of neurology of Baoshan branch of Shanghai First People’s Hospital (China)
Who is the main contact?
Dr Wang Ping
Contact information
Scientific
Haining Road
Hongkou district
Shanghai
200080
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effective of combined physical exercise and cognitive training on cognitive function in stroke survivors with vascular cognitive impairment: a randomised controlled trial |
| Study objectives | The purpose of the present study was to investigate the effect of combined physical exercise and cognitive training on cognitive function in stroke survivors with vascular cognitive impairments, and to explore an alternative strategy for preventing cognitive decline in stroke patients. |
| Ethics approval(s) | Ethics and Research Committee of Nanjing Medical University |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | The trialists used the online Research Randomizer (http://www.randomizer.org) to generate the allocation sequence, applying block randomization to achieve four groups with a ratio of 1:1:1:1. A progressive number was assigned to each of the participants in alphabetical order in terms of their surname, an independent research assistant not involved in the study held this random lists of number. After the competition of consents and baseline measurements, the research assistant contacted the participants to determine the next allocation. Participants were randomly assigned to physical exercise, cognitive training, combined intervention or usual treatment (control group). They received training for approximately 50-60 minutes per day, 3 days per week for 12 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured at baseline, 8 weeks and 6 months: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 260 |
| Key inclusion criteria | 1. Aged over 18 years 2. Medically stable 3. Less than six months post stroke 4. Able to understand and follow verbal instructions 5. Without severe somatic diseases and mental disorders including anxiety and depression 6. Without visual or auditory disturbances in a recent month 7. Met the diagnostic criteria of vascular cognitive impairment |
| Key exclusion criteria | 1. Motor deficits 2. Non-stroke related neurological impairments 3. Clinically determined to be unsafe to perform physical activity |
| Date of first enrolment | 23/02/2017 |
| Date of final enrolment | 24/03/2017 |
Locations
Countries of recruitment
- China
Study participating centre
Hongkou District
Shanghai
200080
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Wang Xiao Ping (wangxp018@njmu.edu.cn). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
