Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training in Stroke Patients
NCT03045991, Not applicable, Completed, Chang Gung Memorial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training in Stroke Patients | ClinicalTrials.gov |
| NCT number | NCT03045991 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 2 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Chang Gung Memorial Hospital | ClinicalTrials.gov |
| Conditions | Stroke Patients With Cognitive Decline | ClinicalTrials.gov |
| Interventions | aerobic exercise training, control training, cognitive training | ClinicalTrials.gov |
| First posted | 2017-02-08 | ClinicalTrials.gov |
| Last updated | 2020-02-05 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change scores of Montreal Cognitive Assessment (MoCA) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 | ClinicalTrials.gov |
| Primary | Change scores of Wechsler Memory Scale - Third Edition (WMS-III) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions | ClinicalTrials.gov |
| Primary | Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The WAIS-III is developed to measure an individual's intelligence level. It includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed | ClinicalTrials.gov |
| Primary | Change scores of Useful Field of View (UFOV) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention. | ClinicalTrials.gov |
| Primary | Change scores of Stroop Color-Word test | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions. | ClinicalTrials.gov |
| Primary | Change scores of Dual-task test | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The dual-task test evaluates the ability to shift attention between one task and another. Participants will perform the box and block test (BBT) while doing secondary cognitive tasks while sitting. Participants will perform BBT by affected and less affected hand. | ClinicalTrials.gov |
| Secondary | Change scores of serum BDNF level | Baseline, posttest (an expected average of 3 months) | Up-regulation of neurotrophic and vascular growth factors | ClinicalTrials.gov |
| Secondary | Change scores of Antioxidative marker | Baseline, posttest (an expected average of 3 months) | Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC). | ClinicalTrials.gov |
| Secondary | Change scores of Glucose indicator | Baseline, posttest (an expected average of 3 months) | HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise | ClinicalTrials.gov |
| Secondary | Change scores of Plasma lipid level | Baseline, posttest (an expected average of 3 months) | The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood. | ClinicalTrials.gov |
| Secondary | Change scores of Functional Independence Measure (FIM) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities. | ClinicalTrials.gov |
| Secondary | Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The Lawton IADL scale assesses independent living skills, such as shopping or managing finances. | ClinicalTrials.gov |
| Secondary | Change scores of Stroke Impact Scale (SIS) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items. | ClinicalTrials.gov |
| Secondary | Change scores of Caregiver Burden (CB) scale | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | CB scale evaluates the burden of the primary caregiver of the participants. Lessening the burden of caregivers after the intervention may significantly improve the quality of life for patients with stroke and their family. | ClinicalTrials.gov |
| Secondary | Change scores of EuroQol (EQ)-5D questionnaire | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The quality of life will be assessed by the EQ-5D questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | ClinicalTrials.gov |
| Secondary | Change scores of Timed up and go test (TUG) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. | ClinicalTrials.gov |
| Secondary | Change scores of Six-minute walk test (6MWT) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test. | ClinicalTrials.gov |
| Secondary | Change scores of Mobility level | Baseline, posttest (an expected average of 3 months) | Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor. | ClinicalTrials.gov |
| Secondary | Change scores of International Physical Activity Questionnaires (IPAQ) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The IPAQ is an international measure of health-related physical activity. | ClinicalTrials.gov |
| Secondary | Change scores of Fugl-Meyer Assessment (FMA) | Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months) | The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 30639273 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Field of View Speed Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)