Effects of Exercise Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

NCT02119546 | Completed DMC

• 1 other identifier: 200912126R
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are:

1. 1.To investigate whether a 3-month exercise training program would improve cognitive function, motor performance, integrity of brain fiber tracts and cerebral blood flow;
2. 2.To investigate the possible neuro-anatomical and neurophysiological mechanisms of exercise training on cognitive function, motor performance, integrity of brain fiber tract and cerebral blood flow in patients with mild cognitive impairment and in those with early Alzheimer's disease;
3. 3.To investigate the influence of different apolipoprotein E (APOE) genotypes on the above-mentioned exercise effects.

Conditions

Mild CognitIve Impairment; Alzheimer's Disease

Keywords

Mild CognitIve impairment; Alzheimer's disease; Cognitive function; Exercise training

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Color Trails Test at week12 and Week24

  To investigate the cognitive executive function

  Baseline, Week12, Week24

Secondary Outcomes (1)

• Change from baseline in walking speed at week12 and Week24

  baseline, week12 and Week24

Study Arms (2)

Exercise intervention

EXPERIMENTAL

Aerobic exercise and dual-task training

Other: Aerobic exercise

Stretch exercise

ACTIVE COMPARATOR

Stretch exercise \& sitting balance

Other: Stretch exercise

Interventions

Aerobic exercise OTHER

Aerobic exercise and dual-task training

Exercise intervention

Stretch exercise OTHER

Stretch exercise \& sitting balance

Stretch exercise

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~85 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 activity of daily living /instrumental activities of daily living, and not demented
• Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable Alzheimer disease (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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Exercise; Plyometric Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Ming-Jang Chiu, PhD

  Neurology department, National Taiwan University Hospital

  STUDY CHAIR

• Yu-Hsiu Chu, PhD

  Department of Physical Therapy, China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: April 21, 2014
• Study Start: May 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

TW (1)