Clinical trial NCT03619577: The Effectiveness of Combining Physical Exercise and Cognitive Training for Individuals With Mild Cognitive Impairment
Official title: The Effectiveness of Combining Physical Exercise and Cognitive Training for Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
cognitive training
exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Therefore, providing effective interventions are necessary. Combining cognitive training and physical exercise training appears to have effects to prevent the progression of MCI to Alzheimer's disease or other severe cognitive impairment. It was proposed that cognitively challenging stimulations can increase the neural network and promote neural plasticity, which are essential for preventing cognitive decline in patients with MCI. The studies also showed that physical exercise induces positive effects on cerebral blood flow and induces brain activation changes of the frontal, parietal, and temporal areas; these cortical areas are especially important for memory and other cognitive functions. However, it is yet not clear the appropriate frequency of the effective intervention for patients with MCI. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency sequential training for patients with MCI.

Detailed description: Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, resulting in increased family care and medical expenses. Therefore, providing effective interventions are necessary. Combining cognitive training and physical exercise training appears to have effects to prevent the progression of MCI to Alzheimer's disease or other severe cognitive impairment. It was proposed that cognitively challenging stimulations can increase the neural network and promote neural plasticity, which are essential for preventing cognitive decline in patients with MCI. The studies also showed that physical exercise induces positive effects on cerebral blood flow and induces brain activation changes of the frontal, parietal, and temporal areas; these cortical areas are especially important for memory and other cognitive functions. However, it is yet not clear the appropriate frequency of the effective intervention for patients with MCI. Thus, this study aims to compare the intervention effects of high frequency sequential and low frequency sequential training for patients with MCI.

Investigators anticipate recruiting a total of 80 participants with MCI. The participants will be assigned into 2 groups: high frequency sequential training (HF) and low frequency sequential training (LF) groups. The participants of HF will receive a total of 36 training sessions, and each session will contain 90-105 minutes of training. The participants of LF will receive a total of 12 training sessions, and each session will contain 90-105 minutes of training. The BrainHQ program, self-made teaching aids and board games will be used to train different cognitive functions of the participants. For physical exercise, Investigators design the programs that involve balance or strength training components in the aerobic exercises. All participants will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. Investigators plan to assess the participants before and after the intervention programs. The primary outcome measures are cognitive functions, including visuospatial processing, attention, memory, and/or executive functions. The secondary outcome measures include physical functions and activities of daily living (ADLs). Investigators expect to use the paired-t test and analysis of covariance (ANCOVA) to analyze differences in baseline characteristics and baseline outcome measures between the groups and determine the intervention effect for the 2 groups.

Eligibility criteria: Inclusion Criteria:

* able to follow instruction (MMSE\>= 17)
* self- or informant-reported memory or cognitive complaint.

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.

Primary outcomes:
measure: Change scores of the Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Stroop test
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Dual-task test
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Timed up and go (TUG) test
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Wechsler Memory Scale (WMS)
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Wechsler Adult Intelligence Scale (WAIS)
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of Memory complaint questionnaire
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of Spatial Span Test
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Secondary outcomes:
measure: Change scores of the short form of the Geriatric Depression Scale (GDS-SF)
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Community Integration Questionnaire (CIQ)
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
measure: Change scores of the Everyday Cognition scales (ECog)-12 items
timeFrame: baseline, posttest (around 12 weeks after baseline), follow-up (6 months after completing intervention sessions)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: