Effects of the Physical Activity and Cognitive Training Program

April 11, 2014 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan Unversity Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care Group:
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.
Experimental: High-intensity physical activity (5PA)
The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks.
Behavioral: Physical Activity
group-based physical activity
Experimental: Low-intensity PA and CT(3PA+2CT)
The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks.
Behavioral: Physical Activity
group-based physical activity
Behavioral: Cognitive Training
individual-based, multi-domains cognitive training
Experimental: High-intensity PA and CT (5PA+5CT)
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.
Behavioral: Physical Activity
group-based physical activity
Behavioral: Cognitive Training
individual-based, multi-domains cognitive training
Experimental: Low-intensity cognitive training (2CT)
The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks.
Behavioral: Cognitive Training
individual-based, multi-domains cognitive training
Experimental: High-intensity cognitive training (5CT)
The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks.
Behavioral: Cognitive Training
individual-based, multi-domains cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Cognitive Function at 8 weeks and 16weeks
Time Frame: 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
pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Depression at 8 weeks and 16weeks
Time Frame: 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.
pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:
Time Frame: 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.
pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Meei-Fang Lou, PhD, Department of Nursing, College of Medicine, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201112011RID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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