Effect of Exercises Training in Patients With Mild Cognitive Impairment and Early Alzheimer's Disease

NCT02074215 | Completed DMC

• 1 other identifier: 201012136RB
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies have shown that aerobic exercises and dual-task training are effective in improving overall cognitive function in patients with cognitive impairment or dementia. However, the biological mechanisms are unknown in humans. It also remains unclear regarding whether carrying APOEε4 genotype or not would influence the effects. Therefore, the three main purposes of this study are: (1) to investigate the effects of a 3-month aerobic exercises combined with dual-task training on memory and executive cognitive functions in patients with mild cognitive impairment (MCI) and in those with early Alzheimer's disease (AD); (2) to compare the differences in training effects between patients who carry APOEε4 genotype and those who do not carry this genotype; and (3) to investigate the biological mechanisms of the exercise training effects on memory and executive cognitive function in these patients. The biological mechanisms of interest will include the blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine, integrity of brain fiber tracts, and cerebral blood flow. We will conduct a randomized controlled clinical trial. A total of 70 patients with MCI or AD will be recruited. The participants will be randomly assigned to the experimental group or the control group. Both groups will receive three 90-minute exercise sessions per week for 12 weeks. For the experimental group, the exercise program will include moderate intensity aerobic exercises and dual-task training; whereas for the control group, the training program will include gentle stretching exercises. Both groups will receive examinations on outcome variables, including blood Aβ1-40 and Aβ1-42 level, insulin, fasting glucose, cytokine,integrity of brain fiber tracts, cerebral blood flow, cognitive function, and dual task performance at baseline, post-training, and after a 3-month follow-up period. Differences on the aforementioned outcomes brought by the 12-week training programs will be compared between the experimental and control groups. Exercise effects between patients who carry APOEε4 genotype and those who do not will also be examined. Results of this study will provide relevant clinical evidence for the effects of aerobic exercises combined with dual-task training on patients with MCI and mild AD; and will provide further understanding of the mechanisms mediating these effects.

Conditions

Alzheimer's Disease

Keywords

Mild Cognitive Impairment; Alzheimer's disease; Aerobic exercise

Outcome Measures

Primary Outcomes (1)

• Changes of Memory and executive function related neuropsychological test

  Changes from baseline in neuropsychological test at 3 months and 6 months

Secondary Outcomes (1)

• Changes of muscle strength of upper and lower extremity and walking speed

  Changes from baseline in muscle strength of upper and lower extremity and walking speed at 3 months and 6 months

Study Arms (2)

Aerobic exercises

EXPERIMENTAL

90-minute exercise sessions per week for 12 weeks

Other: Aerobic exercises

Stretch exercise

ACTIVE COMPARATOR

90-minute exercise sessions per week for 12 weeks

Other: Stretch exercise

Interventions

Aerobic exercises OTHER

Aerobic exercises + dual task

Aerobic exercises

Stretch exercise OTHER

Stretch exercise

Stretch exercise

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild cognitive impairment or mild AD.

You may not qualify if:

• neurological disorders or psychiatric disorders, or any other systematic diseases that would affect their walking ability

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Exercise; Plyometric Exercise

Condition Hierarchy (Ancestors)

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

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

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: February 28, 2014
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

TW (1)