Cognitive Decline Clinical Trial
Official title:
The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
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.
Status | Recruiting |
Enrollment | 270 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan Unversity Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ) | No |
Secondary | 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 ) | No |
Secondary | 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 ) | No |
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