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The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline

Primary Purpose

Aging

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Training
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring life-style activities, cognitive functions

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • able to follow instruction (MMSE>= 20)
  • self- or informant-reported memory or cognitive complaint.

Exclusion Criteria:

  • recent myocardial infarction,heart failure,recent heart surgery,
  • severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle Redesign Training

Arm Description

The participants will receive a total of 12 training sessions, and each session will contain 120 minutes of training.

Outcomes

Primary Outcome Measures

Change scores of the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Change scores of Mini-Mental State Exam (MMSE)
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.
Change scores of the Stroop test
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Change scores of the Timed up and go (TUG) test
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo & Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent.
Change scores of the Dual-task test
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).

Secondary Outcome Measures

Change scores of the Community Integration Questionnaire (CIQ)
The social participation level will be assessed with the Community Integration Questionnaire (CIQ).It contains 15 items to evaluate the degree of integration into each of the three area of family, social network, and productive activities. The total scores range from 0 to 29 with larger numbers indicating better integration.
Change scores of Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression.

Full Information

First Posted
December 29, 2020
Last Updated
May 13, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04689763
Brief Title
The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline
Official Title
The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Taiwan is already an aging society due to the rapid increase of the aging population. To cope with this situation, it is necessary to make preparations for the care of the elderly. World Health Organization (WHO) proposed aging health strategy in recent years, and the community participation is the most important for the elderly. The courses provided by the community empowering are important to promote the healthy life of the elderly. However, at this stage, there are relatively few courses related to cognitive functions, life-style activities and aging education. It is needed to add more courses related to multi-domain.
Detailed Description
Taiwan is already an aging society due to the rapid increase of the aging population. To cope with this situation, it is necessary to make preparations for the care of the elderly. World Health Organization (WHO) proposed aging health strategy in recent years, and the community participation is the most important for the elderly. The courses provided by the community empowering are important to promote the healthy life of the elderly. However, at this stage, there are relatively few courses related to cognitive functions, life-style activities and aging education. It is needed to add more courses related to multi-domain. Investigators anticipate recruiting a total of 50 participants with cognitive decline. The participants will receive a total of 12 training sessions, and each session will contain 120 minutes of training. The programs contain sequential cognitive and exercise training, health lectures, and groups of daily living participation. Investigators plan to assess the participants before and after the intervention programs. Investigators expect that elders receiving training will improve on outcome measures. The results of the study will provide evidence of interventions for elderly with cognitive decline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
life-style activities, cognitive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Redesign Training
Arm Type
Experimental
Arm Description
The participants will receive a total of 12 training sessions, and each session will contain 120 minutes of training.
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
The programs contain sequential cognitive and exercise training, health lectures, and groups of daily living participation. We plan to assess the participants before and after the intervention programs. We expect that elders receiving training will improve on outcome measures. The results of the study will provide evidence of interventions for elderly with cognitive decline.
Primary Outcome Measure Information:
Title
Change scores of the Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of Mini-Mental State Exam (MMSE)
Description
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of the Stroop test
Description
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of the Timed up and go (TUG) test
Description
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo & Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent.
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of the Dual-task test
Description
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of the Wechsler Adult Intelligence Scale (WAIS)
Description
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)
Description
Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1).
Time Frame
baseline, posttest (around 12 weeks after baseline)
Secondary Outcome Measure Information:
Title
Change scores of the Community Integration Questionnaire (CIQ)
Description
The social participation level will be assessed with the Community Integration Questionnaire (CIQ).It contains 15 items to evaluate the degree of integration into each of the three area of family, social network, and productive activities. The total scores range from 0 to 29 with larger numbers indicating better integration.
Time Frame
baseline, posttest (around 12 weeks after baseline)
Title
Change scores of Geriatric Depression Scale (GDS)
Description
The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression.
Time Frame
baseline, posttest (around 12 weeks after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: able to follow instruction (MMSE>= 20) self- or informant-reported memory or cognitive complaint. Exclusion Criteria: recent myocardial infarction,heart failure,recent heart surgery, severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Yi Wu, ScD
Phone
#886-3-2118800
Ext
5761
Email
cywu@mail.cgu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Yi Wu, ScD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Yi Wu, ScD
Phone
+886-3-2118800
Ext
5761
Email
cywu@mail.cgu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline

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