Aerobic Exercise for Late-Life Depression

(FIT BOLD Trial)

Overseen By Miranda Nadeo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Neurological conditions, Cancer treatment, Cardiovascular events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{2 3 5 10 11}

Research Team

Swathi Gujral, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Aerobic Exercise Experimental Treatment 2 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 Engagement Active Control 1 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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 14,343 participants over an average of 12 years, higher levels of cardiorespiratory fitness (CRF) were linked to a significantly lower risk of developing depressive symptoms, with men showing a 31% lower risk at moderate CRF and 51% lower at high CRF.

Women also benefited from higher CRF, with a 44% lower risk at moderate levels and 54% lower at high levels, indicating that maintaining good fitness can be an important factor in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of cardiorespiratory fitness and depressive symptoms in women and men. Sui, X., Laditka, JN., Church, TS., et al.[2022]

Depressed patients often have low physical fitness due to inactivity, suggesting that incorporating physical fitness training into treatment for depression could be beneficial.

Exercise, including both aerobic and nonaerobic forms, has been shown to have antidepressant effects in patients with mild to moderate depression, and many patients continue exercising after treatment, leading to lower depression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of exercise for the treatment of depression. Martinsen, EW.[2022]

Higher cardiorespiratory fitness (CRF) is linked to a lower risk of purchasing antidepressants or anxiolytics, with each 1-MET increase in CRF reducing the risk by 4%, based on a study of 32,603 participants from the Trøndelag Health Study.

Men and younger adults (ages 20-65) with intermediate to high CRF levels showed a significantly reduced risk of needing these medications, suggesting that improving fitness may be a protective factor against mental health medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness and incident use of anxiolytics and antidepressants in adults. A linkage study between HUNT and the Norwegian Prescription Database. Havnen, A., Zotcheva, E., Bjerkeset, O., et al.[2023]

In a study of 165 adults with unipolar depression, strength training significantly improved work capacity, reducing absenteeism by 12.1% compared to relaxation training, while aerobic training showed no significant effect on work absence.

Despite improvements in physical strength and aerobic capacity, neither strength nor aerobic training led to significant reductions in depression severity as measured by the Hamilton Rating Scale for Depression (HAM-D(17)) at 4 or 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Krogh, J., Saltin, B., Gluud, C., et al.[2019]

In a study of 7354 adults from the NHANES survey, anaerobic muscle strengthening activity was found to be significantly associated with lower odds of depression, particularly in women under 50 and all women, even when controlling for aerobic activity.

The combination of anaerobic activity and meeting the Physical Activity Guidelines for America was linked to the lowest odds of depression in both men and women, suggesting that incorporating strength training can be an effective strategy for reducing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaerobic muscle strengthening physical activity and depression severity among USA adults. Cangin, C., Harris, R., Binkley, P., et al.[2020]

In a study of 17,839 U.S. adults, those who engaged in both moderate-to-vigorous physical activity (MVPA) and muscle-strengthening exercise (MSE) had the lowest likelihood of reporting depressive symptoms, indicating a strong association between combined physical activity and better mental health.

Participants meeting both MVPA and MSE guidelines showed significantly lower prevalence ratios for mild to severe depressive symptoms compared to those who did not meet either guideline, highlighting the importance of a comprehensive exercise approach for mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between aerobic and muscle-strengthening exercise with depressive symptom severity among 17,839 U.S. adults. Bennie, JA., Teychenne, MJ., De Cocker, K., et al.[2020]

In a study of 20 elderly patients with major depressive disorder, those who engaged in aerobic exercise alongside their pharmacological treatment showed a significant decrease in depressive symptoms over one year, unlike the control group that only received medication.

The exercise group also maintained stable cortical activity in the right hemisphere, while the control group experienced a decrease in this activity, suggesting that aerobic training may protect against declines in brain function associated with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic training on EEG alpha asymmetry and depressive symptoms in the elderly: a 1-year follow-up study. Deslandes, AC., Moraes, H., Alves, H., et al.[2022]

A 3-week supervised aerobic exercise program significantly reduced depressive symptoms in Chinese patients with mild to moderate depression, showing a mean difference of 10.08 points on the MADRS scale compared to a control group.

The aerobic exercise group also improved physical performance, specifically flexibility, with a mean difference of 4.4 points, suggesting that exercise can enhance both mental and physical health during the early inpatient phase of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise training on chinese population with mild to moderate depression in Hong Kong. Ho, CW., Chan, SC., Wong, JS., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of progressive resistance training in depressed elders. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A randomized trial of aerobic exercise for major depression: examining neural indicators of reward and cognitive control as predictors and treatment targets. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of moderate and vigorous walking exercise on reducing depression in middle-aged and older adults: A pilot randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Prospective study of cardiorespiratory fitness and depressive symptoms in women and men. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Benefits of exercise for the treatment of depression. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiorespiratory fitness and incident use of anxiolytics and antidepressants in adults. A linkage study between HUNT and the Norwegian Prescription Database. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Anaerobic muscle strengthening physical activity and depression severity among USA adults. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Associations between aerobic and muscle-strengthening exercise with depressive symptom severity among 17,839 U.S. adults. [2020]

10. Brazil pubmed.ncbi.nlm.nih.gov

Effect of aerobic training on EEG alpha asymmetry and depressive symptoms in the elderly: a 1-year follow-up study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise training on chinese population with mild to moderate depression in Hong Kong. [2021]