46 Participants Needed

Aerobic Exercise for Late-Life Depression

(FIT BOLD Trial)

MZ
SK
MN
Overseen ByMiranda Nadeo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is aerobic exercise safe for humans?

Aerobic exercise is generally considered safe for humans and is associated with various health benefits, including a lower risk of developing depressive symptoms. Studies have shown that higher levels of cardiorespiratory fitness, which can be achieved through aerobic exercise, are linked to a reduced risk of depression without indicating any significant safety concerns.12345

How does the treatment 'Fitness for Brain Optimization' differ from other treatments for late-life depression?

Fitness for Brain Optimization, which involves aerobic exercise, is unique because it targets depression by improving physical fitness and potentially enhancing brain function related to reward processing and cognitive control. Unlike traditional drug treatments, it offers a non-pharmacological approach that can also improve overall quality of life and physical health.678910

What data supports the effectiveness of the treatment Aerobic Exercise for Late-Life Depression?

Research shows that exercise, including aerobic exercise, can help reduce depression symptoms in older adults. Studies indicate that both moderate and vigorous aerobic activities can lower depression severity and improve quality of life.167811

Who Is on the Research Team?

SG

Swathi Gujral, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Eligible to undergo MRI
I have a reliable way to get to my appointments.
I have experienced a major depressive episode after turning 55.
See 8 more

Exclusion Criteria

Psychosis
I am currently receiving treatment for cancer, not including non-melanoma skin cancer.
I have not had electroconvulsive therapy in the last year.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in aerobic exercise training for cognitive and brain health improvement

6 months
Weekly supervised sessions, with additional home-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • At-home AE
  • Fitness for Brain Optimization
  • On-site AE
  • Social Engagement
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic ExerciseExperimental Treatment2 Interventions
Group II: Social EngagementActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

A 10-week study involving 32 older adults (ages 60-84) found that progressive resistance training (PRT) significantly reduced depression levels and improved quality of life without any adverse events.
Participants in the PRT group experienced a 33% increase in strength and significant improvements in various quality of life measures, indicating that exercise can be a safe and effective intervention for depression in the elderly.
A randomized controlled trial of progressive resistance training in depressed elders.Singh, NA., Clements, KM., Fiatarone, MA.[2022]
In a study of 66 young adults with major depression, 8 weeks of moderate-intensity aerobic exercise significantly reduced depressive symptoms compared to light stretching, with a moderate effect size (gs = 0.66).
While aerobic exercise did not change neural markers of reward processing (RewP) or cognitive control (ERN), individuals with higher baseline RewP and greater depressive symptom severity were more likely to benefit from the exercise intervention.
A randomized trial of aerobic exercise for major depression: examining neural indicators of reward and cognitive control as predictors and treatment targets.Brush, CJ., Hajcak, G., Bocchine, AJ., et al.[2022]
A 12-week study involving 35 middle-aged and older adults found that both moderate (150 minutes) and vigorous (75 minutes) walking exercises significantly reduced depression severity compared to a control group.
Both exercise intensities also led to improvements in anxiety severity, quality of life, and cardiorespiratory fitness, indicating that either level of physical activity can be effective for alleviating depression.
Comparison of moderate and vigorous walking exercise on reducing depression in middle-aged and older adults: A pilot randomized controlled trial.Yu, DJ., Yu, AP., Leung, CK., et al.[2023]

Citations

A randomized controlled trial of progressive resistance training in depressed elders. [2022]
A randomized trial of aerobic exercise for major depression: examining neural indicators of reward and cognitive control as predictors and treatment targets. [2022]
Comparison of moderate and vigorous walking exercise on reducing depression in middle-aged and older adults: A pilot randomized controlled trial. [2023]
Prospective study of cardiorespiratory fitness and depressive symptoms in women and men. [2022]
Benefits of exercise for the treatment of depression. [2022]
Cardiorespiratory fitness and incident use of anxiolytics and antidepressants in adults. A linkage study between HUNT and the Norwegian Prescription Database. [2023]
The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression. [2019]
Anaerobic muscle strengthening physical activity and depression severity among USA adults. [2020]
Associations between aerobic and muscle-strengthening exercise with depressive symptom severity among 17,839 U.S. adults. [2020]
Effect of aerobic training on EEG alpha asymmetry and depressive symptoms in the elderly: a 1-year follow-up study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of aerobic exercise training on chinese population with mild to moderate depression in Hong Kong. [2021]
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
Terms of Service·Privacy Policy·Cookies·Security