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Completed

NCT Number: NCT01724151

Effects of Exercise Training in Patients With Mild Cognitive Impairment

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

  • 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.
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

Primary outcomes

  1. Walking speed of participants

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2012
First posted
Nov 9, 2012
Registry last updated
Apr 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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