Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-30

Study Completion Date

2019-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive training group (Cog)

The 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.

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

visuospatial, attention, memory, and executive abilities

Physical exercise group (PE)

The 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.

Group Type ACTIVE_COMPARATOR

Physical exercise

Intervention Type BEHAVIORAL

endurance, balance, and mobility

Sequential training group (Seq)

The 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.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

visuospatial, attention, memory, and executive abilities

Physical exercise

Intervention Type BEHAVIORAL

endurance, balance, and mobility

Dual-task training group (Dual)

In 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.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

visuospatial, attention, memory, and executive abilities

Physical exercise

Intervention Type BEHAVIORAL

endurance, balance, and mobility

Interventions

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Cognitive training

visuospatial, attention, memory, and executive abilities

Intervention Type BEHAVIORAL

Physical exercise

endurance, balance, and mobility

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes