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Effects of the Physical Activity and Cognitive Training Program

Primary Purpose

Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Physical Activity
Cognitive Training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Decline focused on measuring Physical activity, Cognitive training

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan Unversity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Usual Care Group:

High-intensity physical activity (5PA)

Low-intensity PA and CT(3PA+2CT)

High-intensity PA and CT (5PA+5CT)

Low-intensity cognitive training (2CT)

High-intensity cognitive training (5CT)

Arm Description

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.

The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks.

The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.

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.

The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks.

The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline Cognitive Function at 8 weeks and 16weeks
Cognitive Function: Cognitive Assessment Screening Instrument (CASI) 2.0 in Chinese version

Secondary Outcome Measures

Change from Baseline Depression at 8 weeks and 16weeks
Depression: Geriatric depression scale (GDS)-15 in Chinese version.
Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:
Quality of Life: Short Form-12 (SF-12) in Chinese version.

Full Information

First Posted
November 2, 2012
Last Updated
April 11, 2014
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02114125
Brief Title
Effects of the Physical Activity and Cognitive Training Program
Official Title
The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline
Keywords
Physical activity, Cognitive training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group:
Arm Type
No Intervention
Arm Description
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.
Arm Title
High-intensity physical activity (5PA)
Arm Type
Experimental
Arm Description
The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks.
Arm Title
Low-intensity PA and CT(3PA+2CT)
Arm Type
Experimental
Arm Description
The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.
Arm Title
High-intensity PA and CT (5PA+5CT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-intensity cognitive training (2CT)
Arm Type
Experimental
Arm Description
The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks.
Arm Title
High-intensity cognitive training (5CT)
Arm Type
Experimental
Arm Description
The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
group-based physical activity
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
individual-based, multi-domains cognitive training
Primary Outcome Measure Information:
Title
Change from Baseline Cognitive Function at 8 weeks and 16weeks
Description
Cognitive Function: Cognitive Assessment Screening Instrument (CASI) 2.0 in Chinese version
Time Frame
pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Secondary Outcome Measure Information:
Title
Change from Baseline Depression at 8 weeks and 16weeks
Description
Depression: Geriatric depression scale (GDS)-15 in Chinese version.
Time Frame
pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Title
Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:
Description
Quality of Life: Short Form-12 (SF-12) in Chinese version.
Time Frame
pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meei-Fang Lou, PhD
Phone
886-2-23123456
Ext
88441
Email
mfalou@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Ning Tseng, PhC
Phone
886-2-23123456
Ext
88441
Email
kabyjean@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meei-Fang Lou, PhD
Organizational Affiliation
Department of Nursing, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Unversity Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meei-Fang Lou, PhD
Phone
886-2-23123456
Ext
88441
Email
mfalou@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chien-Ning Tseng, PhC
Phone
886-2-23123456
Ext
88441
Email
kabyjean@gmial.com

12. IPD Sharing Statement

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Effects of the Physical Activity and Cognitive Training Program

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