Effects of the Physical Activity and Cognitive Training Program

NCT02114125 | Unknown DMC

• 1 other identifier: 201112011RID
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline

Keywords

Physical activity; Cognitive training

Outcome Measures

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

  pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )

Secondary Outcomes (2)

• Change from Baseline Depression at 8 weeks and 16weeks

  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:

  pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )

Study Arms (6)

Usual Care Group:

NO INTERVENTION

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

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

Behavioral: Physical Activity

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Low-intensity cognitive training (2CT)

EXPERIMENTAL

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

Behavioral: Cognitive Training

High-intensity cognitive training (5CT)

EXPERIMENTAL

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

Behavioral: Cognitive Training

Interventions

Physical Activity BEHAVIORAL

group-based physical activity

High-intensity PA and CT (5PA+5CT); High-intensity physical activity (5PA); Low-intensity PA and CT(3PA+2CT)

Cognitive Training BEHAVIORAL

individual-based, multi-domains cognitive training

High-intensity PA and CT (5PA+5CT); High-intensity cognitive training (5CT); Low-intensity PA and CT(3PA+2CT); Low-intensity cognitive training (2CT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan Unversity Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Meei-Fang Lou, PhD

  Department of Nursing, College of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meei-Fang Lou, PhD

CONTACT

886-2-23123456; mfalou@ntu.edu.tw

Chien-Ning Tseng, PhC

CONTACT

886-2-23123456; kabyjean@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: April 15, 2014
• Study Start: February 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

TW (1)