Effects of the Physical Activity and Cognitive Training Program

Not Applicable

• Conditions: Cognitive Decline
• Interventions: Behavioral: Physical Activity; Behavioral: Cognitive Training

• Registration Number: NCT02114125
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-11-02
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-11
• Last Update Submitted: 2014-04-11
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-intensity physical activity (5PA)	Physical Activity	The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks.
Low-intensity PA and CT(3PA+2CT)	Physical Activity	The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.
Low-intensity PA and CT(3PA+2CT)	Cognitive Training	The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.
High-intensity PA and CT (5PA+5CT)	Physical Activity	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.
High-intensity PA and CT (5PA+5CT)	Cognitive Training	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.
Low-intensity cognitive training (2CT)	Cognitive Training	The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks.
High-intensity cognitive training (5CT)	Cognitive Training	The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan Unversity Hospital; 🇨🇳 Taipei, Taiwan