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

NCT ID: NCT03545152

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-07-31

Brief Summary

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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

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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

Conditions

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Mild Cognitive Impairment TTM Physical Activity Cognitive Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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)

New life-style

Intervention Type BEHAVIORAL

Combination of exercise and cognitive interventions

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.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type 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

Intervention Type BEHAVIORAL

Combination of exercise and cognitive interventions

Interventions

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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)

Intervention Type 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.

Intervention Type BEHAVIORAL

New life-style

Combination of exercise and cognitive interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tzu-Ting Huang

OTHER

Sponsor Role lead

Responsible Party

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Tzu-Ting Huang

Professor, School of Nursing

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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103-7443B

Identifier Type: -

Identifier Source: org_study_id

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