The effective of a combined intervention in stroke survivors with vascular cognitive impairment

The effective of combined physical exercise and cognitive training on cognitive function in stroke survivors with vascular cognitive impairment: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16009172

Enrollment

260

Registered

2018-07-24

Start date

2017-02-23

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

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 progre

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Motor deficits 2. Non-stroke related neurological impairments 3. Clinically determined to be unsafe to perform physical activity

Design outcomes

Primary

Measure	Time frame
Measured at baseline, 8 weeks and 6 months: 1. Cognitive flexibility of participants assessed with Trail Making Part B, where participants traced a line alternating between encircled numbers and letters (e.g., 1-A-2-B-3-C). The test is time-limited (maximum 300 s), where shorter times denote better cognitive flexibility. 2. Selective attention and conflict resolution assessed with Stroop test, whereby the participant judges the presenting color words (e.g., RED) displayed in either congruent (e.g., red) or in-congruent (e.g., green) colors. The participants required to judge the ink color of the word as accurately and as soon as possible. The time to complete the task was record for each condition. 3. Capacity to hold numbers in working memory and the ability to operate with them assessed with forward digit span, where random number sequences of increasing length were presented verbally to the participants (e.g., “3, 8, 5”), who then repeated the numbers back to the examiner in forward order immediately. One point was scored for each correct sequence repeat (maximum score 14). 4. Spatial imagination measured using mental rotation test. The participants were presented with sheets of paper that had a standard object in the left and four comparison objects in the right site. Two of the comparison items were the same and two were mirror rotated. Participants had to decide which of the two comparison items the same as the standard item were. There were a total of 12 tasks presented in the test. The participants were given three minutes to solve the test. One point was given only if both correct sample stimuli of a cube figure were identified correctly. Participants could achieve a maximum of 12 points.	—

Measure

Time frame

Measured at baseline, 8 weeks and 6 months: 1. Cognitive flexibility of participants assessed with Trail Making Part B, where participants traced a line alternating between encircled numbers and letters (e.g., 1-A-2-B-3-C). The test is time-limited (maximum 300 s), where shorter times denote better cognitive flexibility. 2. Selective attention and conflict resolution assessed with Stroop test, whereby the participant judges the presenting color words (e.g., RED) displayed in either congruent (e.g., red) or in-congruent (e.g., green) colors. The participants required to judge the ink color of the word as accurately and as soon as possible. The time to complete the task was record for each condition. 3. Capacity to hold numbers in working memory and the ability to operate with them assessed with forward digit span, where random number sequences of increasing length were presented verbally to the participants (e.g., “3, 8, 5”), who then repeated the numbers back to the examiner in forward order immediately. One point was scored for each correct sequence repeat (maximum score 14). 4. Spatial imagination measured using mental rotation test. The participants were presented with sheets of paper that had a standard object in the left and four comparison objects in the right site. Two of the comparison items were the same and two were mirror rotated. Participants had to decide which of the two comparison items the same as the standard item were. There were a total of 12 tasks presented in the test. The participants were given three minutes to solve the test. One point was given only if both correct sample stimuli of a cube figure were identified correctly. Participants could achieve a maximum of 12 points.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026