- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558839
The Effect of Exercise and Cognitive Training on Community-dwelling Older Adults With Dementia.
The Effect of Exercise and Cognitive Training on the Physical Fitness, Fall, and Cognition Among Community-dwelling Older Adults With Dementia.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise 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.
|
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.
|
|
Experimental: cognitive training
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional physical fitness
Time Frame: 14 weeks (Before and after interventions)
|
Physiological measurements:
|
14 weeks (Before and after interventions)
|
|
Falls risk assessment
Time Frame: 14 weeks (Before and after interventions)
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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. |
14 weeks (Before and after interventions)
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|
Cognitive Assessment
Time Frame: 14 weeks (Before and after interventions)
|
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. |
14 weeks (Before and after interventions)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chang Hui-Wen, M.D., Member
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-02-022B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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