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The Effectiveness of Combining Physical Exercise and Cognitive Training for Individuals With Mild Cognitive Impairment

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Chang Gung Medical Foundation

Status

Unknown

Conditions

Mild Cognitive Impairment

Treatments

Behavioral: Sequential training

Study type

Interventional

Funder types

Other

Identifiers

NCT03619577
201711EM006

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

55 to 95 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Sequential training-high frequency
Experimental group
Description:
The participants of HF will receive a total of 36 training sessions, and each session will contain 90-105 minutes of training. The participants in this group will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. The participants in this group participate in multimodel exercise programs including aerobic exercise, balance, and strength training. The entire program will contain 5-10 minutes of warm-up, 35-40 minutes of physical exercise, and 5 minutes of cool-down. Then, the participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions for 45-50 minutes.
Treatment:
Behavioral: Sequential training
Sequential training-low frequency
Experimental group
Description:
The participants of LF will receive a total of 12 training sessions, and each session will contain 90-105 minutes of training. The participants in this group will first perform 45-55 minutes of physical exercise followed by 45-50 minutes of cognitive training. The participants in this group participate in multimodel exercise programs including aerobic exercise, balance, and strength training. The entire program will contain 5-10 minutes of warm-up, 35-40 minutes of physical exercise, and 5 minutes of cool-down. Then, the participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions for 45-50 minutes.
Treatment:
Behavioral: Sequential training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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