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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02114125
Other study ID # 201112011RID
Secondary ID
Status Recruiting
Phase N/A
First received November 2, 2012
Last updated April 11, 2014
Start date February 2012
Est. completion date July 2015

Study information

Verified date April 2014
Source National Taiwan University Hospital
Contact Meei-Fang Lou, PhD
Phone 886-2-23123456
Email mfalou@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

1. to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.

2. to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.


Recruitment information / eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
group-based physical activity
Cognitive Training
individual-based, multi-domains cognitive training

Locations

Country Name City State
Taiwan National Taiwan Unversity Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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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