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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Mild Cognitive Impairment; Cognitive Rehabilitation; TTM
• Intervention / Treatment: Behavioral: Exercise; Behavioral: New life-style; Behavioral: Cognitive training

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: comparison group; No procedure conducted between the pre- and the post-test evaluations, and they received an abridged version of the training after the post-test session.
Experimental: exercise group; The exercise program will include instructions on how to read the program, complete the activities, record their sessions, and exercise safely at first day. To promote incorporating exercising in their daily life routine during the 24-week period, we provided 2 group-based (5-8 participants with 2 instructors at community centers, 60' each) and one home-based (with the exercise program VCD and manual to bring home, 30') exercise program.	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); Behavioral: New life-style; Combination of exercise and cognitive interventions
Experimental: cognitive training group; 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.	Behavioral: New life-style; Combination of exercise and cognitive interventions; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 α is .91.	3min
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

Collaborators and Investigators

• Sponsor: Tzu-Ting Huang

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 103-7443B