NCT01962038

Brief Summary

The purpose of this study is examine the efficacy of a combination physical exercise and cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive Impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

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

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4.2 years

First QC Date

August 26, 2013

Last Update Submit

April 3, 2018

Conditions

Keywords

Mild Cognitive ImpairmentAging

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline to 28 weeks in delayed recall of a word list

    Baseline, 24 weeks, 28 weeks

  • Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task

    Baseline, 24 weeks, 28 weeks

Secondary Outcomes (1)

  • Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)

    Baseline, Time 2, Time 3

Other Outcomes (1)

  • Exercise Assessment

    Baseline, Time 2, and Time 3

Study Arms (2)

Combined Aerobic and Resistance Exercise/Cognitive Training

ACTIVE COMPARATOR
Behavioral: Combined Aerobic and Resistance ExerciseBehavioral: Cognitive Training

Stretching Exercises/Cognitive Training

ACTIVE COMPARATOR
Behavioral: Stretching ExercisesBehavioral: Cognitive Training

Interventions

Gym and home based aerobic and resistance exercises

Combined Aerobic and Resistance Exercise/Cognitive Training

Gym and home based stretching exercises

Stretching Exercises/Cognitive Training

Group-based cognitive training

Combined Aerobic and Resistance Exercise/Cognitive TrainingStretching Exercises/Cognitive Training

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of amnestic Mild Cognitive Impairment
  • available informant
  • visual and auditory acuity to allow neuropsychological testing
  • willingness to participate in exercise training + cognitive training for 8 months
  • approval of primary provider to participate in exercise trial

You may not qualify if:

  • current severe psychiatric disorder
  • diagnosis of dementia
  • history of neurological or system illness affecting CNS function
  • acute illness or unstable chronic illness
  • current severe cardiac disease
  • inability to exercise consistently because of orthopedic or musculoskeletal problems
  • morbid obesity
  • inability to read, verbalize understanding and voluntarily sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Fairchild JK, Myers J, Louras P, Jo B, McNerney MW, Hallmayer J, Yesavage J. Multimodal Exercise and Cognitive Training Program Improves Cognitive Function in Amnestic Mild Cognitive Impairment. Am J Geriatr Psychiatry. 2024 Apr;32(4):463-474. doi: 10.1016/j.jagp.2023.12.002. Epub 2023 Dec 11.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Muscle Stretching ExercisesCognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNeurological RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jennifer K Fairchild, PhD

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

August 26, 2013

First Posted

October 14, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2017

Study Completion

November 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations