Fitness for Brain Optimization for Late-Life Depression

NCT04670510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-11-28

No results posted yet for this study

Summary

Cognitive impairment and brain abnormalities are common and persist after depression remission in those with Late Life Depression (LLD), compounding dementia risk in both individuals with acute and remitted LLD (rLLD). In this study, investigators will examine systemic neural and cognitive benefits of aerobic exercise training in older adults with remitted LLD. This will generate preliminary data regarding neural targets of aerobic exercise training that may translate to cognitive benefits in those with rLLD, a population who remains at high risk for dementia despite successful treatment of depression.

Conditions

  • Depression in Old Age

Interventions

OTHER

On-site AE

Participants will attend on-site supervised AE sessions 3 times per week for the first 6 weeks, twice weekly for weeks 7-12; once weekly for weeks 13-18. All supervised sessions will start and end with 5-minute warm-up and cool-down and will involve exercise on the treadmill, elliptical, and/or bike. During AE sessions, participants will exercise so that their heart rate is approximately 65% of their peak heart rate and gradually increase the intensity of exercise so that their heart rate is between 70 and 85% of their peak heart rate. All participants will wear heart rate monitors and encouraged to exercise in their target heart rate zone. Supervised AE sessions will gradually increase to 50-minutes per session

OTHER

At-home AE

Participants will increase at-home AE during the 6-month intervention period with weeks 19-26 occurring entirely at-home. As participants transition to home-based exercise, they will be equipped with a polar heart rate monitor and will be instructed to use this to record average heart rate during each exercise session. On a log sheet, they will record both average heart rate during exercise and average subjective rating of perceived exertion (RPE) during each exercise session.

OTHER

Social Engagement (SE)

To control for the social component of the AE intervention participants in the SE group will be invited to attend at total of 25 group meetings over the course of the 6-month study period.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Swathi Gujral, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2025-10-22
Completion
2025-10-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670510 on ClinicalTrials.gov