Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment
1 other identifier
interventional
55
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2019
CompletedJuly 12, 2019
May 1, 2019
3 years
July 20, 2015
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change scores of Montreal Cognitive Assessment (MoCA)
The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop test
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.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
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.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go (TUG) test
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).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary Outcomes (17)
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)
- +12 more secondary outcomes
Study Arms (4)
Cognitive training group (Cog)
ACTIVE COMPARATORThe BrainHQ program will be used to train different cognitive functions of the participants. The participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions. The tasks will become more difficult as the participants progress in their abilities.
Physical exercise group (PE)
ACTIVE COMPARATORThe participants in this group participate in multimodal exercise programs including aerobic exercise, balance, and strength training. The entire exercise program for the PE group will contain 10 minutes of warm-up, 70 minutes of physical exercise, and 10 minutes of cool-down. The 70 minutes of exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period.
Sequential training group (Seq)
EXPERIMENTALThe participants in this group will first perform 45 minutes of physical exercise followed by 45 minutes of cognitive training. The physical exercise training will be similar to the programs used in the PE group. The entire exercise program for the PE group will contain 5 minutes of warm-up, 35 minutes of physical exercise, and 5 minutes of cool-down. The cognitive training will be implemented with BrainHQ similar to what has been described in the COG group.
Dual-task training group (Dual)
EXPERIMENTALIn this group, the participants will be instructed to perform physical exercise and cognitive tasks simultaneously (e.g., math calculation while stepping). The difficulty of the cognitive tasks will increase as the participants improve in their performance.
Interventions
visuospatial, attention, memory, and executive abilities
endurance, balance, and mobility
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Baliexcelsior Nursing Home
New Taipei City, 249, Taiwan
Pine nursing home
Taichung, 412, Taiwan
Zhishan community home
Taipei, 11150, Taiwan
Bailing clinics and nursing homes
Taipei, 11165, Taiwan
Shihlin cum day care center
Taipei, 111, Taiwan
Xihu day care center
Taipei, 11443, Taiwan
TaoSheng Nursing home
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Chang Gung Memorial Hospital Taoyuan Branch
Taoyuan District, Taiwan
Related Publications (1)
Lee YY, Wu CY, Teng CH, Hsu WC, Chang KC, Chen P. Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study. Trials. 2016 Oct 28;17(1):526. doi: 10.1186/s13063-016-1650-4.
PMID: 27793183DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Yi Wu, ScD
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 31, 2015
Study Start
January 30, 2015
Primary Completion
January 29, 2018
Study Completion
March 13, 2019
Last Updated
July 12, 2019
Record last verified: 2019-05