Non-pharmacological Interventions on Cognitive Functions in Older People With Mild Cognitive Impairment
1 other identifier
interventional
192
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedJune 14, 2019
June 1, 2019
3 years
May 22, 2018
June 12, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Mobility
10min
Depressive symptoms
3min
Quality of life
8min
Study Arms (3)
comparison group
NO INTERVENTIONNo procedure conducted between the pre- and the post-test evaluations, and they received an abridged version of the training after the post-test session.
exercise group
EXPERIMENTALThe 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.
cognitive training group
EXPERIMENTALConsisted 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.
Interventions
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 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.
Combination of exercise and cognitive interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- using walking devices
- depression or dementia diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tzu-Ting Huanglead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, School of Nursing
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 4, 2018
Study Start
August 1, 2015
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
June 14, 2019
Record last verified: 2019-06