Effects of the Physical Activity and Cognitive Training Program

NCT ID: NCT02114125

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Cognitive Decline

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

High-intensity physical activity (5PA)

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

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

group-based physical activity

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.

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

group-based physical activity

Cognitive Training

Intervention Type BEHAVIORAL

individual-based, multi-domains cognitive training

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.

Group Type EXPERIMENTAL

Physical Activity

Intervention Type BEHAVIORAL

group-based physical activity

Cognitive Training

Intervention Type BEHAVIORAL

individual-based, multi-domains cognitive training

Low-intensity cognitive training (2CT)

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

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

individual-based, multi-domains cognitive training

High-intensity cognitive training (5CT)

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

Group Type EXPERIMENTAL

Cognitive Training

Intervention Type BEHAVIORAL

individual-based, multi-domains cognitive training

Interventions

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Physical Activity

group-based physical activity

Intervention Type BEHAVIORAL

Cognitive Training

individual-based, multi-domains cognitive training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meei-Fang Lou, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, College of Medicine, National Taiwan University

Locations

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National Taiwan Unversity Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Meei-Fang Lou, PhD

Role: CONTACT

886-2-23123456 ext. 88441

Chien-Ning Tseng, PhC

Role: CONTACT

886-2-23123456 ext. 88441

Facility Contacts

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Meei-Fang Lou, PhD

Role: primary

886-2-23123456 ext. 88441

Chien-Ning Tseng, PhC

Role: backup

886-2-23123456 ext. 88441

Other Identifiers

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201112011RID

Identifier Type: -

Identifier Source: org_study_id

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