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Effects of the Physical Activity and Cognitive Training Program

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National Taiwan University

Status

Unknown

Conditions

Cognitive Decline

Treatments

Behavioral: Physical Activity
Behavioral: Cognitive Training

Study type

Interventional

Funder types

Other

Identifiers

NCT02114125
201112011RID

Details and patient eligibility

About

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.

Full 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.

Enrollment

270 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

270 participants in 6 patient groups

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

Trial contacts and locations

1

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Central trial contact

Meei-Fang Lou, PhD; Chien-Ning Tseng, PhC

Data sourced from clinicaltrials.gov

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