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Status unknownNCT02114125Updated Apr 15, 2014

Effects of the Physical Activity and Cognitive Training Program

An interventional study of Physical Activity and Cognitive Training in Cognitive Decline, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2014-04-15.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cognitive Decline

Keywords

  • Physical activity
  • Cognitive training
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 270 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
270 participants (estimated)

Study arms

  • 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

  • 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 · Behavioral: 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 · Behavioral: 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

  • 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

Interventions

  • BehavioralPhysical Activity

    group-based physical activity

  • BehavioralCognitive Training

    individual-based, multi-domains cognitive training

06

What researchers measure

Primary outcomes

  1. Change from Baseline Cognitive Function at 8 weeks and 16weeks

    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 outcomes

  1. Change from Baseline Depression at 8 weeks and 16weeks

    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 )

  2. Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:

    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 )

07

Study locations

1 of 1 sites recruiting
  • National Taiwan Unversity Hospital
    Taipei, 100, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02114125
Lead sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
Responsible party
Sponsor
First posted
Apr 15, 2014
Start date
Feb 2012
Primary completion
Jul 2015 (estimated)
Completion
Jul 2015 (estimated)
Last update
Apr 15, 2014

Study contacts

Meei-Fang Lou, PhD
Contact
mfalou@ntu.edu.tw
886-2-23123456 ext. 88441
Chien-Ning Tseng, PhC
Contact
kabyjean@gmail.com
886-2-23123456 ext. 88441
Meei-Fang Lou, PhD
principal investigator · Department of Nursing, College of Medicine, National Taiwan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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