Exercise Training to Improve Cognitive Function

Mild Cognitive Impairment Clinical Trial

Official title:

Exercise Training to Improve Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824639
• Other study ID #: E2545-P
• Status: Completed
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: June 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Background/Rationale:

Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in coming decades. AD is known to have a long preclinical phase in which pathophysiologic processes develop many years, even decades, before the onset of clinical symptoms. During this preclinical phase there is evidence of unremitting decline in cognitive function, particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological interventions to slow this decline in cognitive function has been limited, leading to increasing interest in the utility of nonpharmacological interventions including exercise.

Objective:

The investigators propose to assess the feasibility of a novel home-based exercise intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).

Methods:

The investigators will estimate the difference between the intervention (n=30) and the control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis for sample size calculation for a proposed larger study. Participants will be male and female Veterans 50 years of age or older with amnestic MCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Amnestic MCI

• Ability to use a telephone without assistance

Exclusion Criteria:

• Angina Pectoris

• History of myocardial infarction within 6 months

• History of ventricular dysrhythmia requiring current therapy

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Structured exercise
Exercise instruction and encouragement
• Health Education
Provision of general information about a variety of health topics

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Delayed Recall Score on the Rey-Osterrieth Complex Figure Test From Baseline to 6 Months	Rey-Osterrieth Complex Figure Test is a recall test involving a complex figure. Possible scores on the delayed recall task range from 0 (no accurate details recalled for the figure) to 36 (all details accurately recalled for the figure). Outcome is change in the delayed recall score from baseline to 6 months.	baseline and 6 months