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

NCT02114580 | Unknown

• 1 other identifier: 0051-14-TLV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment; exercise; brain plasticity; FMRI

Outcome Measures

Primary Outcomes (1)

• functional Magnetic Resonance Imaging

  two weeks prior to intervention

Secondary Outcomes (1)

• Neuropsychological assessment

  two weeks prior to intervention

Other Outcomes (1)

• Cardiorespiratory fitness assessment, Serum concentration of BDNF

  two weeks prior to intervention

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Other: physical training

stretching exercise

ACTIVE COMPARATOR

Other: physical training

Interventions

physical training OTHER

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.

Aerobic exercise; stretching exercise

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64288, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yulia Lerner, PhD

  Functional Brain Center, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talma Hendler, MD

CONTACT

97236973953; hendlert@gmail.com

Nir Giladi, MD

CONTACT

97236974790; nirg@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 15, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 15, 2014

Record last verified: 2014-03

Locations

IL (1)