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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03545152
Enrollment
192
Registered
2018-06-04
Start date
2015-08-01
Completion date
2018-07-31
Last updated
2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Rehabilitation, Mild Cognitive Impairment, Physical Activity, TTM

Brief 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.

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

Interventions

BEHAVIORALExercise

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)

BEHAVIORALCognitive 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.

BEHAVIORALNew life-style

Combination of exercise and cognitive interventions

Sponsors

Tzu-Ting Huang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mini-Mental State Examination8minThe participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education).
The Alzheimer's Questionnaire2minMalek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting.
Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)5minThere 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.

Secondary

MeasureTime frameDescription
Mobility10minThe 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
Depressive symptoms3minA 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.
Quality of life8minThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026