Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 55
- Locations
- 9
- Primary Endpoint
- Change scores of Montreal Cognitive Assessment (MoCA)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.
Detailed Description
Background and study aims: Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The age-adjusted prevalence of MCI in Taiwan is approximately 18%, while women have higher prevalence for MCI than men. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that cognitive training or exercise has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining exercise and cognitive training remain to be determined. Furthermore, whether exercise and cognitive training should be administered in sequential order or simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects cognitive training, exercise, and combining cognitive and exercise training in individuals with MCI. Who can participate? Individuals with MCI. What does the study involve? The participants will receive a total of 36 training sessions, and each session will contain 90 minutes of training. Training frequency will be 2-3 times per week for 12-18 weeks. All participants will received pretreatment test, post treatment test, and a 6-month follow-up test. What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, physical, and daily functions. There are no risks for participating. Where to conduct the study? The investigators anticipate recruiting a total of 80 participants from geriatric day care centers and nursing homes from multiple cities in Taiwan.
Investigators
Eligibility Criteria
Inclusion Criteria
- •able to follow instruction,
- •clinical dementia rating (CDR) = 0.5 or 1,
- •self- or informant-reported memory or cognitive complaint, and
- •able to perform activities of daily living (Barthel Index ≥ 70).
Exclusion Criteria
- •recent myocardial infarction,
- •heart failure,
- •recent heart surgery,
- •severe asthma,
- •concomitant with other neurological disorders, or
- •joint deformity that might prevents them performing exercise or cognitive training.
Outcomes
Primary Outcomes
Change scores of Montreal Cognitive Assessment (MoCA)
Time Frame: 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.
Change scores of Stroop test
Time Frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Change scores of Dual-task test
Time Frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
Change scores of Timed up and go (TUG) test
Time Frame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then 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 and frail elderly (Podsiadlo \& Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, \& Scherder, 2013).
Secondary Outcomes
- Change scores of the Lawton Instrumental Activities of Daily Living Scale(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Verbal Fluency Test(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Useful Field of View (UFOV)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the 30 second chair stand test (CST)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Chinese version of the International Physical Activity Questionnaires (IPAQ)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Barthel Index (BI)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- BDNF val66met genotype(baseline)
- Change scores of the Community Integration Questionnaire (CIQ)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Disability Assessment for Dementia (DAD)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Caregiver Burden Inventory (CBI)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the Geriatric Depression Scale (GDS)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of evaluating isometric knee flexors and extensors muscle strength(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of using hand dynamometer to measure grip strength of both hand(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- Change scores of Wechsler Memory Scale - Third Edition (WMS-III)(baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
- 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))