The Effect of Exercise and Cognitive Training on Community-dwelling Older Adults With Dementia.
Primary Purpose
Dementia, Exercise, Fall
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A 12-week weekly sports and cognitive training intervention.
Sponsored by
About this trial
This is an interventional prevention trial for Dementia
Eligibility Criteria
Inclusion Criteria:
- The list of dementia cases under the supervision of the Taipei City Government Health Bureau, who are over 65 years of age and have been diagnosed with mild to moderate dementia.
- Those who can participate in sports activities.
- Those who can communicate in both Chinese and Taiwanese, have self-determination ability and can clearly express their wishes.
Exclusion Criteria:
- Those who have exercise contraindications due to medical reasons.
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
exercise training
cognitive training
Arm Description
Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down.
Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm. Each cognitive session uses different board games to strengthen training for different cognitive aspects.
Outcomes
Primary Outcome Measures
functional physical fitness
Physiological measurements:
The 30 second chair stand test is for testing leg strength and endurance in older adults. This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded. This reflects lower body strength.
The handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles.
The 8-foot up-and-go test is used to measure balance, agility, and speed while walking or moving.
Falls risk assessment
We reported fall risk was assessed with the STRATIFY assessment tool(St. Thomas Risk Assessment Tool in Falling Elderly Inpatients) by questionnaire.
Falls risk assessment tool is used to identify fall risk factors for falls in the elderly and to predict the chance of falling.
This tool comprises five items addressing risk factors: past history of falling, patient agitation, visual impairment, incontinence, transfer and mobility. The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling is a score ≥ 2 points.
Cognitive Assessment
We reported cognitive assessment was assessed with the Taiwan version of Montreal Cognitive Assessment (MoCA-T) by questionnaire.
The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. The MoCA contains 30 questions and takes around 10 to 12 minutes to complete. The MoCA checks different types of cognitive or thinking abilities. These include: orientation, short-term memory/delayed recall, executive function/visuospatial ability, language, abstraction, animal naming, attention, and clock-drawing test. The MoCA test uses a 30-point scale and take only 10 to 12 minutes. to complete. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
Secondary Outcome Measures
Full Information
NCT ID
NCT05558839
First Posted
September 7, 2022
Last Updated
September 25, 2022
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05558839
Brief Title
The Effect of Exercise and Cognitive Training on Community-dwelling Older Adults With Dementia.
Official Title
The Effect of Exercise and Cognitive Training on the Physical Fitness, Fall, and Cognition Among Community-dwelling Older Adults With Dementia.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community-dwelling older adults with dementia. The exercise and cognitive training intervention of this study promoted physical fitness, reduced chance of falling, and improved the cognitive functions of community-dwelling older adults with dementia. In addition, the score of risk of falling reduced.
Detailed Description
Taiwan has become an aged society, and its population with dementia increases rapidly. Older adults with dementia have unfavorable balance ability and may lack muscle strength; consequently, their probability of falling is twice as high as that of healthy older adults, and their probability of falling and being hospitalized is three times that for general healthy older adults. Compared to European countries and the United States, Taiwan has limited studies on older adults with dementia regarding effects of exercise and cognitive intervention. To develop an intervention for older adults with dementia that integrates exercise and cognitive training to promote or maintain their physical fitness and cognitive function to reduce their risk of falling is critical.
This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community older adults with mild or moderate dementia. Participants were recruited from 5 community-based dementia care centers in Taipei City. A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved one hour of sports training and one hour of cognitive training.
Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down.
Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm.
Each cognitive session uses different board games to strengthen training for different cognitive aspects.
Before and after the intervention, data of the participants' functional physical fitness, their scores of the STRATIFY Falls Risk Assessment, and their scores of the Montreal Cognitive Assessment were collected as the outcome indicators. A paired t test was used to analyze the results of the intervention. This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community older adults with dementia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Exercise, Fall, Cognitive Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community-dwelling older adults with mild or moderate dementia.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise training
Arm Type
Experimental
Arm Description
Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down.
Arm Title
cognitive training
Arm Type
Experimental
Arm Description
Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm.
Each cognitive session uses different board games to strengthen training for different cognitive aspects.
Intervention Type
Behavioral
Intervention Name(s)
A 12-week weekly sports and cognitive training intervention.
Intervention Description
A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved 1 hour of sports training and 1 hour of cognitive training.
Primary Outcome Measure Information:
Title
functional physical fitness
Description
Physiological measurements:
The 30 second chair stand test is for testing leg strength and endurance in older adults. This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded. This reflects lower body strength.
The handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles.
The 8-foot up-and-go test is used to measure balance, agility, and speed while walking or moving.
Time Frame
14 weeks (Before and after interventions)
Title
Falls risk assessment
Description
We reported fall risk was assessed with the STRATIFY assessment tool(St. Thomas Risk Assessment Tool in Falling Elderly Inpatients) by questionnaire.
Falls risk assessment tool is used to identify fall risk factors for falls in the elderly and to predict the chance of falling.
This tool comprises five items addressing risk factors: past history of falling, patient agitation, visual impairment, incontinence, transfer and mobility. The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling is a score ≥ 2 points.
Time Frame
14 weeks (Before and after interventions)
Title
Cognitive Assessment
Description
We reported cognitive assessment was assessed with the Taiwan version of Montreal Cognitive Assessment (MoCA-T) by questionnaire.
The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. The MoCA contains 30 questions and takes around 10 to 12 minutes to complete. The MoCA checks different types of cognitive or thinking abilities. These include: orientation, short-term memory/delayed recall, executive function/visuospatial ability, language, abstraction, animal naming, attention, and clock-drawing test. The MoCA test uses a 30-point scale and take only 10 to 12 minutes. to complete. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
Time Frame
14 weeks (Before and after interventions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The list of dementia cases under the supervision of the Taipei City Government Health Bureau, who are over 65 years of age and have been diagnosed with mild to moderate dementia.
Those who can participate in sports activities.
Those who can communicate in both Chinese and Taiwanese, have self-determination ability and can clearly express their wishes.
Exclusion Criteria:
Those who have exercise contraindications due to medical reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Hui-Wen, M.D.
Organizational Affiliation
member
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
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The Effect of Exercise and Cognitive Training on Community-dwelling Older Adults With Dementia.
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