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

Chang Gung Medical Foundation

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Physical exercise; Behavioral: Cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT02512627

103-6651A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

55 participants in 4 patient groups

Cognitive training group (Cog)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive training

Physical exercise group (PE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical exercise

Sequential training group (Seq)

Experimental group

Description:

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.

Treatment:

Behavioral: Physical exercise

Behavioral: Cognitive training

Dual-task training group (Dual)

Experimental group

Description:

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.

Treatment:

Behavioral: Physical exercise

Behavioral: Cognitive training