Effects of the Physical Activity and Cognitive Training Program

Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02114125
• Other study ID #: 201112011RID
• 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

• Cognitive Decline

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