Effects of the Physical Activity and Cognitive Training Program

Study Overview
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Brief Summary
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Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities. The purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.

Detailed Description
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to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner. to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.

Official Title
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The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents

Conditions
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Cognitive Decline

Intervention / Treatment
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* Behavioral: Physical Activity
* Behavioral: Cognitive Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 year and older Able to communicate verbally Able to discern 5*5 cm2 picture from a viewing distance of 20 cm Able to hear a sound of normal speech from a distance of 20 cm Able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort Has cognitive decline status assessing by CASI 2.0 Lived in long-term care facilities during the study Exclusion Criteria: Complete aphasia, blindness, deafness or completely dependent Unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression Thrombophlebitis, or malignancy of the limbs. Refusal by patient or family member. Others. Reason to be well documented.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group:<br>Usual care consists of standard institutionalized services provided by physicians, nurses, and support staff (e.g., nurse assistants, social workers) in long-term care facilities. | |
| Experimental: High-intensity physical activity (5PA)<br>The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks. | Behavioral: Physical Activity<br>* group-based physical activity<br>|
| Experimental: Low-intensity PA and CT(3PA+2CT)<br>The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks. | Behavioral: Physical Activity<br>* group-based physical activity<br>Behavioral: Cognitive Training<br>* individual-based, multi-domains cognitive training<br>|
| Experimental: High-intensity PA and CT (5PA+5CT)<br>The intervention conducts the individual-based, multi-domains cognitive training, 5days per- week and group-based physical activity, 5 days per- week and for 8 weeks. | Behavioral: Physical Activity<br>* group-based physical activity<br>Behavioral: Cognitive Training<br>* individual-based, multi-domains cognitive training<br>|
| Experimental: Low-intensity cognitive training (2CT)<br>The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks. | Behavioral: Cognitive Training<br>* individual-based, multi-domains cognitive training<br>|
| Experimental: High-intensity cognitive training (5CT)<br>The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks. | Behavioral: Cognitive Training<br>* individual-based, multi-domains cognitive training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Cognitive Function at 8 weeks and 16weeks | Cognitive Function: Cognitive Assessment Screening Instrument (CASI) 2.0 in Chinese version | pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Depression at 8 weeks and 16weeks | Depression: Geriatric depression scale (GDS)-15 in Chinese version. | pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 ) | 
| Change from Baseline Quality of Life at 8 weeks and 16weeksStatus: | Quality of Life: Short Form-12 (SF-12) in Chinese version. | pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Cognitive training