Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545152
• Other study ID #: 103-7443B
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: July 31, 2018

Study information

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

Clinical Trial Summary

This project is proposed to be a three-year project. The purposes of this project are to develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Description:

Aim. develop and examine physical activity program, cognitive rehabilitation training, and new life-style (combination of exercise and cognitive) interventions on primary outcomes (cognitive function), and secondary outcomes (physical fitness, QOL and depression) among community-dwelling elderly adults with MCI.

Background. Mild cognitive impairment (MCI) is a common clinical syndrome that identifies people at high risk of developing dementia, and the prevalence range from 7.7 to 51.7%. Although treatments for MCI are currently unavailable, preliminary evidence has identified potential neuro-protective effects of exercise program and cognitive rehabilitation, which may lead to improved outcomes. However, the design and delivery of an appropriate program for people with MCI is challenging for having physical, psychological, cognitive, and social barriers.

Design. A prospective randomized control trial. We developed a Physical activity stage-matched intervention (SMI) (1st year), cognitive rehabilitation (2nd year) and New lifestyle program

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• had a subjective memory complaint

• MMSE score<16, 21 or 24, based on their years of education (illiterate, 6 or >9 years, respectively, Yeh et al., 2000), but needed >13 or objective memory impairment: AQ>5 or at least one item of IADL dependence

• able to carry out activities in daily life

Exclusion Criteria:

• using walking devices

• depression or dementia diagnosis

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Rehabilitation
• Mild Cognitive Impairment
• Physical Activity
• TTM

Intervention

Behavioral:
• Exercise
Prescription exercise: frequency, intensity, type, time, and progression (FITT-PRO). 150 min/week (the intensity will be moderate). exercise routine: warming up, resistance training and aerobic exercise training(range of motion and flexibility exercises)
• Cognitive training
Cognitive training intervention consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.
• New life-style
Combination of exercise and cognitive interventions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tzu-Ting Huang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination	The participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education).	8min
Primary	The Alzheimer's Questionnaire	Malek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting.	2min
Primary	Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)	There are 11 items and include general memory and prospective memory sections for analysis the type and frequency of memory problem in elders' daily live. Items are posed in likert scale ranges from 1 (never) to 5 (always). The total score may range from 11-55. A higher score indicates a higher level of memory impaired.	5min
Secondary	Mobility	The Tinetti Performance-Oriented Mobility Assessment (POMA) is a balance tool that was originally developed for use in the institutionalized, older adult population and contains both a balance and a gait component (Tinetti, 1986). The test comprises 16 items (9 balance-related items and 7 gait-related items), with the highest achievable score being 28 points	10min
Secondary	Depressive symptoms	A short-form Geriatric Depression Scale (GDS) that consisted of 15 questions was the primary outcome measure (Sheikh and Yesavage, 1986). Scores of 0-4 are considered normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression. The Chinese version of the GDS-15 demonstrates high reliability (Liao et al., 2005); in this study, the Cronbach's a is .91.	3min
Secondary	Quality of life	The SF-36 questionnaire was used to measure quality of life. This 36-item questionnaire assesses health-related functions for eight distinct domains, which can be divided into physical component and mental component scales. Subsequent to summing the Likert-scaled items in the SF-36 survey, scores in each scale are standardized so that they each range from 0 to 100.	8min