NCT03855475

Brief Summary

This study will measure brain structure through its mechanical properties, assessed with magnetic resonance elastography, and determine whether it improves with aerobic exercise in older adults with low memory abilities. Additionally, this study will determine if memory abilities improve with exercise and if they are related to brain structure. Overall, this project has the potential to identify how brain health is impacted by exercise in older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

February 14, 2019

Last Update Submit

May 10, 2024

Conditions

Mild Cognitive Impairment

Keywords

ExerciseMemoryBrain

Outcome Measures

Primary Outcomes (1)

  • Change in brain mechanical properties

    Investigators are assessing change in brain structure through mechanical properties in response to exercise from baseline to the end of the 12 week program. An MRI scan with magnetic resonance elastography (MRE) will be used to measure properties of brain regions important to memory (e.g. hippocampus).

    Baseline, 12 weeks

Secondary Outcomes (2)

  • Change in relational memory performance

    Baseline, 12 weeks

  • Change in cardiorespiratory fitness

    Baseline, 12 weeks

Other Outcomes (4)

  • Change in brain morphometry

    Baseline, 12 weeks

  • Change in brain function

    Baseline, 12 weeks

  • Change in brain white matter integrity

    Baseline, 12 weeks

  • +1 more other outcomes

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Exercise training

Behavioral: Aerobic exercise

Stretching

ACTIVE COMPARATOR

Control

Behavioral: Stretching

Interventions

Aerobic exerciseBEHAVIORAL

Participants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle

Aerobic exercise
StretchingBEHAVIORAL

Participants will complete 12 weeks of supervised stretching, 3 times per week

Stretching

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation
  • age 60-90 years
  • MMSE score \>24 at time of initial consent

You may not qualify if:

  • major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years)
  • neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, head trauma with loss of consciousness greater than 30 min, large vessel infarct)
  • other systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure, diabetes, chronic obstructive pulmonary disease, liver diseases, hypertension)
  • current medication use likely to affect CNS functions (e.g. long active benzodiazepines)
  • failed outcome on the baseline graded exercise test
  • hypertension (systolic 130+ mmHg OR diastolic 80+ mmHg) from baseline blood pressure measurement
  • claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning
  • concussion within last 2 years and more than 3 lifetime concussions
  • current smoking (including marijuana) within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Curtis L Johnson, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 26, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)