NCT03824639

Brief Summary

This project is assessing the feasibility of a novel home-based exercise intervention to improve episodic memory in individuals with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 14, 2024

Completed
Last Updated

February 14, 2024

Status Verified

June 1, 2023

Enrollment Period

3.1 years

First QC Date

January 29, 2019

Results QC Date

June 6, 2023

Last Update Submit

June 6, 2023

Conditions

Keywords

Mild cognitive impairmentexercise therapypatient adherence

Outcome Measures

Primary Outcomes (1)

  • Change in Delayed Recall Score on Wechsler Logical Memory Task From Baseline to 6 Months

    Wechsler Logical Memory Task is a recall test involving 2 short stories. Possible scores on the delayed recall task range from 0 (no details recalled for both stories) to 50 (all details recalled on both stories). Outcome is change in the delayed recall score from baseline to 6 months.

    baseline and 6 months

Secondary Outcomes (1)

  • Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months

    baseline and 6 months

Study Arms (2)

Exercise group

EXPERIMENTAL

Structured exercise

Behavioral: Structured exercise

Control group

ACTIVE COMPARATOR

Health education

Behavioral: Health Education

Interventions

Exercise instruction and encouragement

Exercise group

Provision of general information about a variety of health topics

Control group

Eligibility Criteria

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

You may qualify if:

  • Amnestic MCI
  • Ability to use a telephone without assistance

You may not qualify if:

  • Angina Pectoris
  • History of myocardial infarction within 6 months
  • History of ventricular dysrhythmia requiring current therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionPatient Compliance

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System

Study Officials

  • David Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

April 23, 2019

Primary Completion

May 31, 2022

Study Completion

July 31, 2022

Last Updated

February 14, 2024

Results First Posted

February 14, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations