Effects of Exercise Training in Patients With Mild Cognitive Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01724151
First received: February 25, 2010
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

The proposes of this study are

  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. 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. 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.

The study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.


Condition
Mild Cognitive Impairment
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effects of Exercise Training in Patients With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Walking speed of participants [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)


Enrollment: 60
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy adults
Healthy adults, over 45 years old
Mild cognitive impairment
subjects with mild cognitive impairment
Alzheimer's disease
subjects with Alzheimer's disease

Detailed Description:

There is already evidence that exercise training can delay the progression of dementia. But if the same effect could be seen in patients with cognitive impairment remains unknown. There is an increasing importance of how to delay or prevent the turn over of cognitive impairment patients into dementia in recent years. Thus we propose to investigate the following issues.

  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. 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. 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 patients with cognitive impairment.

The study is a cross sectional study. We recruited 40 cognitive impairment patients from the memory clinic at National Taiwan University Hospital and another 20 healthy controls matched for age and gender. We collected the actigram and physical activity from questionnaire for 7 days and performed the analysis for reliability and validity. We will do correlation analysis with the data with resting state functional MRI and tractography, brain connectivity, and plasma Aβ1-40 and Aβ1-42 amyloid protein.

The study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic,community sample

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724151

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Ming-Jang Chiu Neurology department, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01724151     History of Changes
Other Study ID Numbers: 200812152R
Study First Received: February 25, 2010
Last Updated: April 21, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014