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

Mild Cognitive Impairment Clinical Trial

Official title:

Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512627
• Other study ID #: 103-6651A3
• Status: Completed
• Phase: N/A
• Start date: January 30, 2015
• Est. completion date: March 13, 2019

Study information

• Verified date: May 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 13, 2019
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Cognitive training
visuospatial, attention, memory, and executive abilities
• Physical exercise
endurance, balance, and mobility

Locations

Country	Name	City	State
Taiwan	Baliexcelsior Nursing Home??	New Taipei City
Taiwan	Pine nursing home	Taichung
Taiwan	Bailing clinics and nursing homes	Taipei
Taiwan	Shihlin cum day care center	Taipei
Taiwan	TaoSheng Nursing home	Taipei
Taiwan	Xihu day care center	Taipei
Taiwan	Zhishan community home	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Taiwan	Chang Gung Memorial Hospital Taoyuan Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Montreal Cognitive Assessment (MoCA)	The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Primary	Change scores of Stroop test	The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Primary	Change scores of Dual-task test	The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Primary	Change scores of Timed up and go (TUG) test	The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo & Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, & Scherder, 2013).	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Verbal Fluency Test	Verbal fluency tests will be used to evaluate the semantic memory of the participants. The participants will be instructed to say as many words as possible from a given category (i.e., fruit or animal) in 1 minute. The validity, reliability, and normative performance of verbal fluency tests have been well-established (Harrison, Buxton, Husain, & Wise, 2000).	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Useful Field of View (UFOV)	Useful field of view (UFOV) is the visual area over which useful information could be obtained at a quick glance without eye or head movements. This UFOV will be assessed with the BrainHQ program. The UFOV will assess the abilities of visuomotor processing speed, divided attention, and selective attention (Ball, Edwards, & Ross, 2007).	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the 30 second chair stand test (CST)	The 30 second chair stand test (CST) will be assessed to indicate the strength and endurance level of the lower extremities. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using CST in people with cognitive impairment have been established to be good (Blankevoort et al., 2013).	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Chinese version of the International Physical Activity Questionnaires (IPAQ)	The Chinese version of the International Physical Activity Questionnaires (IPAQ) is an international measure for health-related physical activity. A short form of IPAQ will be used to assess changes in physical activity before and after intervention in this study. The reliability and validity of IPAQ has been established across 12 countries (Craig et al., 2003).	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Barthel Index (BI)	Assess activities of daily living	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Lawton Instrumental Activities of Daily Living Scale	Assess activities of daily living.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Disability Assessment for Dementia (DAD)	Assess activities of daily living.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)	The Chinese version of QoLAD will be used.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Caregiver Burden Inventory (CBI)	The Chinese version of CBI will be used.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Geriatric Depression Scale (GDS)	The Chinese version of short form GDS will be used.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the Community Integration Questionnaire (CIQ)	The CIQ measures items relevant to home integration, social integration, and productive activities.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph	The actigraphy will be placed on the waist for a 3-day period immediately before and after the intervention. The participants will wear the actigraphy during all daily activities except for those that involve water (i.e., showering or swimming).	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of evaluating isometric knee flexors and extensors muscle strength	The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements. Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with both lower extremities. The investigators will record the mean value of 3 attempts.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of using hand dynamometer to measure grip strength of both hand	The participant is seated, with the elbow at 90-degree flexion. The investigators will record the mean value of 3 attempts.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of Wechsler Memory Scale - Third Edition (WMS-III)	The investigators will use the WMS-III subtests, including Faces Recognition (score range 0-48), Verbal Paired Associates (score range 0-32), Word Lists (0-48), and Spatial Span (0-32) to assess the immediate, delayed, and working memory tests. Higher scores indicated better performance for each subtest. The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general memory function.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)	The WAIS-III includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed. The subtests that the investigators will use are the Digit Symbol-Coding (scores range 0-133) and Matrix Reasoning tests (0-26). The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general cognitive function.	baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary	BDNF val66met genotype	Saliva samples will be collected at baseline to determine the Brain-Derived Neurotrophic Factor (BDNF) val66met genotype.	baseline