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Completed

NCT Number: NCT03545152

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Behavioral

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

Behavioral

Combination of exercise and cognitive interventions

Primary outcomes

  1. Mini-Mental State Examination

    Time frame: 8min

    The participants' cognitive function was assessed by the Mini-Mental State Examination (cut point base for participants' levels of education).

  2. The Alzheimer's Questionnaire

    Time frame: 2min

    Malek-Ahmadi et al., (2012) a 21-item, informant-based dementia assessment designed for ease of use in a primary care setting.

  3. Taiwan version of Prospectiv and Retrospective Memory Questionaire (PRMQ)

    Time frame: 5min

    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.

Secondary outcomes

  1. Mobility

    Time frame: 10min

    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

  2. Depressive symptoms

    Time frame: 3min

    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.

  3. Quality of life

    Time frame: 8min

    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.

Sponsors and collaborators

Lead sponsor

Tzu-Ting Huang

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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