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Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
physical training
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, exercise, brain plasticity, FMRI

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Only patients at the age of 60-90 who have met criteria for a diagnosis of MCI will be included.
  • Participants will be both men and women, and this factor is not specifically addressed.

Exclusion Criteria:

  • Patients with any significant medical (i.e. cardiac), neurological (other than MCI) illness will be excluded from the study.
  • Medical and neurological illnesses will be ruled out by physical and neurological examinations, reports of the patients' treating physicians and medical records.
  • The experiments will be undertaken in compliance with the safety guidelines for MRI research. Based on initial fMRI screening questionnaires, subjects will be excluded if they indicate any risk factor on these questionnaires.

Sites / Locations

  • Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercise

stretching exercise

Arm Description

Outcomes

Primary Outcome Measures

functional Magnetic Resonance Imaging

Secondary Outcome Measures

Neuropsychological assessment

Full Information

First Posted
March 31, 2014
Last Updated
April 13, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02114580
Brief Title
Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study
Official Title
Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study aims to explore brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that will advance our knowledge about the nature of these mechanisms. Participants will participate in individual- tailored aerobic training program. Pre and post evaluation will identify brain changes following the training using advanced techniques of brain imaging. Cognitive performance will be assessed prior and at the end of the program, as well as endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating cortical plasticity in subjects with aMCI has tremendous practical significance for these subjects .
Detailed Description
Mild cognitive impairment (MCI), a prodromal stage of Alzheimer disease (AD), refers to a transitional state between the cognition of normal aging and dementia such AD. To date, therapeutic approaches to AD are symptomatic and of modest efficacy. Nontheless, recent studies in animal models or healthy subjects, have shown that aerobic exercise affect brain plasticity. The current proposal aims at exploring the brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with amnestic MCI (aMCI),in compare to a control group of subjects with aMCI receiving stretching exercise. More specifically, we aim to perform two fMRI experiments, that will advance our knowledge about the nature of mechanism of the cognitive benefit resulting of aerobic exercise. Our preleminary results suggest that subjects with aMCI show different hierarchy of reliable responses when processing long time scales in auditory task. Therefore, in the first experiment, we will evaluate how these patterns of temporal hierarchy of language processing are affected by aerobic exercise. Next, we will explore whether aerobic exercise affect memory enocoding task, which rely on areas in the medial temporal lobe who bear a heavy neuropathological burden in MCI. The insights gained from the study may have important clinical implications for patients who are at the early stages of Alzheimer's disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, exercise, brain plasticity, FMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Title
stretching exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
physical training
Intervention Description
Participants in both the aerobic and stretching groups will carry out their activity routines 3 d/wk for 45 to 60 minutes per session for 4 months. Training will be on "one on one" basis, where each participant will be supervised by an experienced trainer at the participant's home.Aerobic intervention protocol: subjects will practice with stationary bicycle. Exercise intensity will be monitored through wireless HR monitor. Participants will be also monitored for the intensity of their workouts by the Borg's Rating of Perceived Exertion and the "talk" test (a subjective method for estimating of appropriate cardiorespiratory exercise intensity). Stretching exercise protocol: Participants in the stretching control group will carry out a prescribed routine of stretching and balance exercises.
Primary Outcome Measure Information:
Title
functional Magnetic Resonance Imaging
Time Frame
two weeks prior to intervention
Secondary Outcome Measure Information:
Title
Neuropsychological assessment
Time Frame
two weeks prior to intervention
Other Pre-specified Outcome Measures:
Title
Cardiorespiratory fitness assessment, Serum concentration of BDNF
Time Frame
two weeks prior to intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Only patients at the age of 60-90 who have met criteria for a diagnosis of MCI will be included. Participants will be both men and women, and this factor is not specifically addressed. Exclusion Criteria: Patients with any significant medical (i.e. cardiac), neurological (other than MCI) illness will be excluded from the study. Medical and neurological illnesses will be ruled out by physical and neurological examinations, reports of the patients' treating physicians and medical records. The experiments will be undertaken in compliance with the safety guidelines for MRI research. Based on initial fMRI screening questionnaires, subjects will be excluded if they indicate any risk factor on these questionnaires.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talma Hendler, MD
Phone
97236973953
Email
hendlert@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nir Giladi, MD
Phone
97236974790
Email
nirg@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yulia Lerner, PhD
Organizational Affiliation
Functional Brain Center, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64288
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulia Lerner, PhD

12. IPD Sharing Statement

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Brain Plasticity Following Aerobic Exercise in Patient With Mild Cognitive Impairment: Neuroimaging Study

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