← Back to Search

Aerobic Exercise for Late-Life Depression (FIT BOLD Trial)

N/A
Recruiting
Led By Swathi Gujral, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Major Depressive Episode in older adulthood (since age 55)
Ambulatory without pain or the assistance of walking devices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuously up to every 6-weeks for 6 months
Awards & highlights

FIT BOLD Trial Summary

This trial will investigate whether aerobic exercise training can help improve cognitive function in older adults with remitted late life depression, who are at a high risk for developing dementia.

Who is the study for?
This trial is for men and women over 60 with Late-Life Depression who are currently treated but not experiencing a major depressive episode. They must exercise less than 100 minutes per week, be able to walk without assistance, have no neurological diseases, and can undergo an MRI.Check my eligibility
What is being tested?
The study tests the effects of aerobic exercise on brain function in older adults with remitted Late-Life Depression. Participants will engage in either on-site or at-home aerobic exercises versus social engagement activities to assess cognitive benefits.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of intervention, general risks may include muscle soreness, fatigue, increased heart rate during exercise, and potential discomfort from social interactions or MRI procedures.

FIT BOLD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have experienced a major depressive episode after turning 55.
Select...
I can walk without pain or the need for help like canes or walkers.
Select...
I am 60 years old or older.
Select...
I have not been diagnosed with a neurological disease.

FIT BOLD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuously up to every 2 months for 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously up to every 2 months for 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Cardiovascular Fitness at 6 months
Change from baseline in Cognitive Function at 6 months
Changes from baseline in Brain Structure and Function at 6 months
+2 more
Secondary outcome measures
Change from baseline in Subjective Cognitive Function at 6 months
Change from baseline in amount of physical activity at 6 months
Changes from baseline in intensity of physical activity at 6 months
+1 more

FIT BOLD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic ExerciseExperimental Treatment2 Interventions
The Aerobic Exercise (AE) condition will involve 150-minutes of moderate-intensity AE per week for 6-months and will involve a graded decline in supervision. Supervised AE will occur in groups, though each participant's AE prescription will be personalized based on baseline exercise capacity, as assessed by a maximal cardiopulmonary fitness test. Supervised AE sessions will involve the treadmill, elliptical, and/or bike, and routines will be varied to promote adherence. Supervised AE sessions will gradually increase to 50-minutes per session; however, participants will be encouraged to engage in home-based AE sessions according to their own preference of length and frequency in order to achieve 150 minutes of AE per week.
Group II: Social EngagementActive Control1 Intervention
The Social Engagement (SE) condition will be designed to control for the social component of the AE intervention (i.e., supervised on-site sessions with professional staff, frequent phone contact from study staff). A variety of enjoyable group-based activities centered around the dimensions of wellness (spiritual wellness, physical wellness, emotional wellness, etc.) will be scheduled throughout the intervention. This condition will involve once weekly meetings (grand total of ~26 sessions). Some participants will meet in-person and others will meet remotely via zoom (this will vary week to week) to increase flexibility to accommodate participant availability to attend as many sessions as possible.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,343,106 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,659 Total Patients Enrolled
Swathi Gujral, PhDPrincipal Investigator - University of Pittsburgh
University of Pittsburgh

Media Library

Fitness for Brain Optimization Clinical Trial Eligibility Overview. Trial Name: NCT04670510 — N/A
Late-Life Depression Research Study Groups: Aerobic Exercise, Social Engagement
Late-Life Depression Clinical Trial 2023: Fitness for Brain Optimization Highlights & Side Effects. Trial Name: NCT04670510 — N/A
Fitness for Brain Optimization 2023 Treatment Timeline for Medical Study. Trial Name: NCT04670510 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary goals of this clinical evaluation?

"This clinical trial will primarily evaluate the efficacy of the intervention at reducing levels of depression. Secondary outcomes include changes in physical activity, subjective cognitive function, and intensity of physical activity - measured using wrist actigraphy data - over a period 6 months from baseline."

Answered by AI

What is the current participant cap for this clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov confirms that enrolment for this study is ongoing, having been initially posted on August 4th 2021 and most recently updated November 2nd 2022. 50 participants will be accepted across 1 medical centre."

Answered by AI

Are there any opportunities for new participants to join this experiment?

"According to the documentation on clinicaltrials.gov, this experiment is still in need of participants and was initially advertised on August 4th 2021 with its most recent update being posted November 2nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
UPMC Western Psychiatric Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Fitness for Brain Optimization for Late-Life Depression
Swathi Gujral 2021. "Fitness for Brain Optimization for Late-Life Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04670510.
~20 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top