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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02114580
• Other study ID #: 0051-14-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: March 31, 2014
• Last updated: April 13, 2014
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Talma Hendler, MD
• Phone: 97236973953
• Email: hendlert[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Other:
• physical training
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.

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiorespiratory fitness assessment, Serum concentration of BDNF		two weeks prior to intervention	No
Primary	functional Magnetic Resonance Imaging		two weeks prior to intervention	No
Secondary	Neuropsychological assessment		two weeks prior to intervention	No