NCT01724151

Brief Summary

The proposes of this study are

  1. 1.To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.
  2. 2.To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment, the capability of activity and social engagement (including quality of life).
  3. 3.To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of the patients with cognitive impairment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

February 25, 2010

Last Update Submit

April 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Walking speed of participants

    Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)

    1 hour

Study Arms (3)

Healthy adults

Healthy adults, over 45 years old

Mild cognitive impairment

subjects with mild cognitive impairment

Alzheimer's disease

subjects with Alzheimer's disease

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic,community sample

You may qualify if:

  • Above 45 years old and had independent walking ability
  • The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal ADL/IADL, and not demented
  • Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable AD (McKhann, et al., 1984)

You may not qualify if:

  • The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Ming-Jang Chiu

    Neurology department, National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2010

First Posted

November 9, 2012

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

April 1, 2012

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations