Evolving Methods of Hybrid Exercise-cognition Approach to Promote Health-related Conditions for the Elderly With MCI
NCT03927586, Not applicable, Unknown, Chang Gung Memorial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evolving Methods of Hybrid Exercise-cognition Approach to Promote Health-related Conditions for the Elderly With MCI | ClinicalTrials.gov |
| NCT number | NCT03927586 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chang Gung Memorial Hospital | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Stroke | ClinicalTrials.gov |
| Interventions | cognitive training, physical exercise training | ClinicalTrials.gov |
| First posted | 2019-04-25 | ClinicalTrials.gov |
| Last updated | 2021-06-21 | ClinicalTrials.gov |
Registered outcomes 21
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, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30. The MoCA has been shown to be a valid and promising tool to detect MCI and early Alzhemer's disease (Nasreddine et al., 2005). | ClinicalTrials.gov |
| Primary | Change scores of Verbal fluency test | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | Verbal fluency tests will be used to evaluate the semantic memory of the participants. The participants will be instructed to say as many words as possible from a given category (i.e., fruit or animal) in one minute. The validity, reliability, and normative performance of verbal fluency tests have been well-established (Harrison, Buxton, Husain, \& Wise, 2000). | ClinicalTrials.gov |
| Primary | Change scores of Wechsler Memory Scale - Third Edition (WMS-III) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | We will use the WMS-III subtests, including Faces Recognition, Verbal Paired Associates, Word Lists, and Spatial Span to assess the immediate, delayed, and working memory tests. The Faces Recognition test involves 24 pictures of human faces. The participants will be required to look through the faces one by one, and later recognize those faces. For the Verbal Paired Associates test, the instructor will read out eight-word pairs for the participant to memorize. The participants will be asked to respond to the appropriate word that matches the test word. In the Word Lists test, the instructor will read out 12 words in a list and the participants will need to repeat as many words as they could immediately and 25-35 minutes after. As for the Spatial Span test, the instructor will point to spatially located blocks in a sequential order; the participants will then touch the blocks either in the same sequential order or in a reversed order. | ClinicalTrials.gov |
| Primary | Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | 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. The subtests that we will use are the Digit Symbol-Coding and Matrix Reasoning tests. The Digit Symbol-Coding test consists of 9 digit-symbol pairs and the participants will be asked to write down the corresponding symbols for the given digits on the test sheet as accurately and as fast as possible. As for the Matrix Reasoning test, the participants will need to logically solve missing puzzles within given matrixes. The test result of the Matrix Reasoning test indicates a general intelligence level because it entails the abilities of visual-spatial reasoning, abstract reasoning, visual organization, and visuospatial information processing. | ClinicalTrials.gov |
| Primary | Change scores of Useful Field of View (UFOV) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention (Ball, Edwards, \& Ross, 2007). The UFOV is the visual area over which information can be extracted from a brief glance without eye or head movements. | ClinicalTrials.gov |
| Primary | Change scores of Stroop Color-Word test | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition (Koss, Ober, Delis, \& Friedland, 1984; Ridley, Johnson, \& Braisted, 1978). | ClinicalTrials.gov |
| Primary | Change scores of Dual-task test | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The dual-task test evaluates the ability to shift attention between one task and another. Participants will sit and perform the box and block test (BBT) or walk 10 meters while doing secondary cognitive or motor tasks. Two cognitive secondary tasks will be performed by the participants: (1) arithmetic task: participants will be asked to perform serial subtractions by 7 starting from 100 or random two-digit numbers (e.g., Baetens et al., 2013); (2) tone discrimination task: participants will be presented a number of low and high-pitched tones and they will respond to either the high or low-pitched tones during the trial. Both cognitive task performances will be recorded and the results will be compared to single cognitive task performance. In addition to the cognitive dual-task, participants will perform a motor task (e.g., holding a cup of water) while walking. | ClinicalTrials.gov |
| Primary | Change scores of Timed up and go (TUG) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | 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. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers in frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, \& Scherder, 2013). | ClinicalTrials.gov |
| Primary | Change scores of Sit-to-stand test | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The 30 second sit-to-stand will be assessed to indicate the strength and endurance level of the lower extremities. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using sit-to-stand test in people with cognitive impairment have been established to be good (Blankevoort et al., 2013). | ClinicalTrials.gov |
| Primary | Change scores of International Physical Activity Questionnaires (IPAQ) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Chinese version of the International Physical Activity Questionnaires (IPAQ) is an international measure for health-related physical activity. A short form of IPAQ will be used to assess changes in physical activity before and after intervention in this study. The reliability and validity of IPAQ has been established across 12 countries (Craig et al., 2003). | ClinicalTrials.gov |
| Primary | Change scores of Mobility level | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | 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 (ActiGraph, Shalimar, FL, USA) on both wrists for 3 consecutive days before and after training to measure the number of moves each minute, and the average counts of move per minute. The participants will be required to wear the device during the day except for doing water-based activities, such as bathing or swimming. Data recorded by the actigraphy will be analyzed with the MAHUFFE software (http://www.mrc-epid.cam.ac.uk/). | ClinicalTrials.gov |
| Primary | Change scores of Lower extremity muscle strength | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements. Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with affected and less affected side. We will record the mean value of 3 attempts. | ClinicalTrials.gov |
| Primary | Change scores of Grip strength | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | We will use hand dynamometer to measure grip strength of both hands while the participant is seated, with the elbow at 90-degree flexion. We will record the mean value of 3 attempts. | ClinicalTrials.gov |
| Primary | Change scores of the Barthel Index (BI) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | Assess activities of daily living | ClinicalTrials.gov |
| Primary | Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Lawton IADL scale evaluates 8 activities with a score range from 0 to 8 (higher indicate better function). The inter-rater reliability and validity of the Lawton IADL have been established to be moderate to high for community-dwelling older adults (Graf, 2008; Lawton \& Brody, 1969). | ClinicalTrials.gov |
| Primary | Change scores of the Disability Assessment for Dementia (DAD) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | Assess activities of daily living. | ClinicalTrials.gov |
| Primary | Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The intervention effects on quality of life will be assessed with the Chinese versions of the Quality of Life in Alzheimer's Disease Instrument (QoLAD) | ClinicalTrials.gov |
| Primary | Change scores of Community Integration Questionnaire (CIQ) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The social participation level will be assessed with the CIQ. The CIQ measures 15 items relevant to home integration, social integration, and productive activities (Willer, Ottenbacher, \& Coad, 1994).The CIQ has been tested on various populations with acquired brain injuries, and test-retest reliability was excellent for chronic stroke patients with aphasia (Dalemans, de Witte, Beurskens, van den Heuvel, \& Wade, 2010; Willer et al., 1994). | ClinicalTrials.gov |
| Primary | Change scores of Caregiver Burden Inventory (CBI) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Chinese version of CBI will be used. | ClinicalTrials.gov |
| Primary | Change scores of Short form of Geriatric Depression Scale (GDS) | Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions) | The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 8
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 |
|---|---|---|
| Arithmetic Fluency Task | Primary outcome | ConductCognition |
| Field of View Speed Test | Primary outcome | ConductCognition |
| Lexical Tone Task | Primary outcome | ConductCognition |
| Matrix Reasoning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Word Pair Learning | 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)