Clinical trial NCT02512627: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment
Official title: Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
exercise
cognitive training
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. able to follow instruction,
2. clinical dementia rating (CDR) = 0.5 or 1,
3. self- or informant-reported memory or cognitive complaint, and
4. able to perform activities of daily living (Barthel Index ≥ 70).

Exclusion Criteria:

1. recent myocardial infarction,
2. heart failure,
3. recent heart surgery,
4. severe asthma,
5. concomitant with other neurological disorders, or
6. joint deformity that might prevents them performing exercise or cognitive training.

Primary outcomes:
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Stroop test
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Dual-task test
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Timed up and go (TUG) test
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary outcomes:
measure: Change scores of the Verbal Fluency Test
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Useful Field of View (UFOV)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the 30 second chair stand test (CST)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Chinese version of the International Physical Activity Questionnaires (IPAQ)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Barthel Index (BI)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Lawton Instrumental Activities of Daily Living Scale
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Disability Assessment for Dementia (DAD)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Caregiver Burden Inventory (CBI)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Geriatric Depression Scale (GDS)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the Community Integration Questionnaire (CIQ)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of evaluating isometric knee flexors and extensors muscle strength
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of using hand dynamometer to measure grip strength of both hand
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
timeFrame: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: BDNF val66met genotype
timeFrame: baseline
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Baliexcelsior Nursing Home
city: Taichung
country: Taiwan
facility: Pine nursing home
city: Taipei
country: Taiwan
facility: Zhishan community home
city: Taipei
country: Taiwan
facility: Bailing clinics and nursing homes
city: Taipei
country: Taiwan
facility: Shihlin cum day care center
city: Taipei
country: Taiwan
facility: Xihu day care center
city: Taipei
country: Taiwan
facility: TaoSheng Nursing home
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Taoyuan Branch
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.