Clinical trial NCT03805620: Effects of Combined Physical-cognitive Training on Cognitive Function in MCI
Official title: Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
combined physical-cognitive training
BDNF
mitochondrial function
cognitive function
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 128
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will be superior to the physical and cognitive training program alone; and 2) the degree of cognitive improvement will be positively correlated with the improvement of plasma BDNF and mitochondrial function.

Detailed description: Recent research suggests that the benefits of combined physical-cognitive training may be greater than either physical or cognitive training alone. Nevertheless, this synergistic effect has been demonstrated mainly in cognitively intact older adults. Studies examining the effects of combined physical-cognitive training in older adults with MCI are scarce and show mixed results. Moreover, few studies have determined the effects of the combined training on peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. The present study will provide insight into the interplay among the training program, peripheral BDNF concentration, mitochondrial function, and cognitive function. Importantly, the findings will have clinical implication regarding the training program that is feasible and effective in improving cognitive function of older adults with MCI which ultimately will have great impact on public health as this population is at high risk of progression to AD.

Eligibility criteria: Inclusion Criteria:

* meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based on the recent DSM-V (Diagnostic Statistical Manual-V) criteria
* comprehend instructions and willing to participate
* able to comply with the study schedule and procedures
* not taking any medications for their cognition and not planning to start medications during the study trial

Exclusion Criteria:

* presence of medical conditions that would be unsafe to exercise
* diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis, AD) that affect cognition and mobility
* presence of depressive symptoms
* presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
* exercise regularly (at least 30 min/day, 3 days/week)

Primary outcomes:
measure: change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months
timeFrame: 3 months
measure: change from baseline Rey auditory verbal learning score at 3 months
timeFrame: 3 months
measure: change from baseline Trail Making B-A score at 3 months
timeFrame: 3 months
measure: change from baseline brain-derived neurotrophic factor level at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: change from baseline Digit Span score at 3 months
timeFrame: 3 months
measure: change from baseline stepping response time at 3 months
timeFrame: 3 months
measure: change from baseline time to complete Timed Up and Go at 3 months
timeFrame: 3 months
measure: change from baseline physiological profile assessment score at 3 months
timeFrame: 3 months
measure: change from baseline cellular oxidative stress level at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Faculty of Associated Medical Sciences, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Somporn Sungkarat, PhD
role: PRINCIPAL_INVESTIGATOR
References: