The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04689763
Collaborator
(none)
50
1
1
15
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lifestyle Redesign Training

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

Behavioral: Training
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.

Outcome Measures

Primary Outcome Measures

  1. Change scores of the Montreal Cognitive Assessment (MoCA) [baseline, posttest (around 12 weeks after baseline)]

    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.

  2. Change scores of Mini-Mental State Exam (MMSE) [baseline, posttest (around 12 weeks after baseline)]

    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.

  3. Change scores of the Stroop test [baseline, posttest (around 12 weeks after baseline)]

    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.

  4. Change scores of the Timed up and go (TUG) test [baseline, posttest (around 12 weeks after baseline)]

    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.

  5. Change scores of the Dual-task test [baseline, posttest (around 12 weeks after baseline)]

    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

  6. Change scores of the Wechsler Adult Intelligence Scale (WAIS) [baseline, posttest (around 12 weeks after baseline)]

    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

  7. Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL) [baseline, posttest (around 12 weeks after baseline)]

    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

  1. Change scores of the Community Integration Questionnaire (CIQ) [baseline, posttest (around 12 weeks after baseline)]

    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.

  2. Change scores of Geriatric Depression Scale (GDS) [baseline, posttest (around 12 weeks after baseline)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Taoyuan Taiwan 333

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Ching-Yi Wu, ScD, Chang Gung Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04689763
Other Study ID Numbers:
  • 201912EM017
First Posted:
Dec 30, 2020
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2021