Resilience Training for Age-related Cognitive Decline

(MEDEX-2 Trial)

Enrolling by invitation at 1 trial location

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Inability to safely continue classes

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately three years

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore how stress affects cognitive function and emotional health in older adults, particularly those at risk for Alzheimer's. It will test different approaches, such as exercise, health education, and mindfulness, to determine which methods improve mental resilience and reduce stress impacts. Participants will engage in various activities, like exercise classes or mindfulness sessions, to identify the most beneficial lifestyle changes. Older adults who participated in the previous study and wish to continue these activities are a good fit for this trial. As an unphased trial, it offers participants a unique opportunity to contribute to valuable research that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both exercise and mindfulness-based stress reduction (MBSR) are generally safe and well-tolerated by older adults. Studies have found that moderate aerobic exercise and strength training can boost brain function without causing major side effects. Regular physical activity is linked to better brain health in older adults, making it a safe choice for maintaining mental sharpness.

Mindfulness-based stress reduction has also been widely studied. It helps reduce stress and improve mental well-being with few side effects. In these studies, participants typically practice meditation and gentle movements, which are low-risk activities.

The combination of exercise and mindfulness has been explored as well. While results on brain function improvements vary, this combined approach is considered safe and may enhance mental health and overall well-being.

In summary, both exercise and mindfulness practices appear safe for most people, including older adults. Those considering participation in a trial involving these activities can feel assured of their safety based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for age-related cognitive decline because they offer a holistic approach that integrates physical and mental wellness. Unlike traditional treatments that might focus solely on medication or cognitive exercises, the exercise component improves physical fitness, strength, and balance, potentially reducing frailty. Mindfulness-Based Stress Reduction (MBSR) adds a mental wellness dimension by promoting mindfulness, which may help enhance everyday cognitive function and reduce stress. The combination of MBSR and exercise encourages participants to engage in both mental and physical activities, potentially offering a comprehensive way to address cognitive decline. This integrative approach is what sets these treatments apart from current options.

What evidence suggests that this trial's treatments could be effective for age-related cognitive decline?

Research shows that exercise, one of the treatments in this trial, can enhance brain function and mental health in older adults. Studies consistently find that physical activities like aerobic exercises and strength training benefit brain health, even for those with existing memory or thinking problems.

Mindfulness-Based Stress Reduction (MBSR), another treatment option in this trial, also shows promise. It can improve factors related to dementia risk and enhance brain function. MBSR reduces stress and may slow age-related memory and thinking decline.

This trial will also explore combining MBSR with exercise, which previous studies have shown mixed results. Some studies do not find significant brain improvements from the combination, while others suggest possible benefits. This combined approach aims to support brain performance in older adults. ^{1 6 7 8 9}

Who Is on the Research Team?

Eric Lenze, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for older adults who were part of a previous study (Protocol ID #201410093). They should be able to safely continue with classes and assessments. The focus is on those experiencing cognitive decline or stress related to the COVID-19 pandemic.

Inclusion Criteria

Participated in the parent study, Protocol ID #201410093

Exclusion Criteria

Inability to safely continue classes or complete assessments, as per PI discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in exercise, health education, and mindfulness-based stress reduction activities, with monthly sessions and at-home practice

Approximately three years

Monthly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Health Education
• Mindfulness-Based Stress Reduction
• Mindfulness-Based Stress Reduction + Exercise

Trial Overview

The study tests how health education, mindfulness-based stress reduction, exercise, and a combination of mindfulness plus exercise can impact brain health and resilience during the pandemic among older adults.

How Is the Trial Designed?

Group I: Mindfulness-Based Stress Reduction + Exercise Experimental Treatment 1 Intervention

This condition will receive both MBSR and exercise as described. Participants in this condition will attend monthly sessions with encouragement to complete at-home mindfulness practice as well as at-home exercise for the duration of the study.

Group II: Mindfulness-Based Stress Reduction Experimental Treatment 1 Intervention

Mindfulness-Based Stress Reduction (MBSR) as delivered in the parent study (Protocol ID #201410093) consisted of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content included instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. For the current study, participants will continue monthly approximately 2.5 hour booster sessions covering similar content for the duration of the study. Participants will be encouraged to maintain daily formal meditative activities at home.

Group III: Exercise Experimental Treatment 1 Intervention

The exercise protocol in the parent study (Protocol ID #201410093) was optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty. It consisted of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. For the current study, participants will continue monthly approximately 1.5 hour classes focused on functional training for the duration of the study. Participants will be encouraged to continue between-session engagement in aerobic and resistance training activities at home.

Group IV: Health Education Active Control 1 Intervention

The health education control condition is based on a chronic disease self-management program developed at Stanford University and was used as an attentional control in the parent study (Protocol ID #201410093). This control intervention was designed to be time-equivalent to MBSR, with 8 weeks of 2.5 hour weekly group classes followed by monthly booster sessions for approximately 15 months. For the current study, participants will continue monthly approximately 1.5 hour sessions covering similar content for the duration of the study.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

This pilot study will involve 30 women with breast cancer, focusing on the integration of mindfulness and exercise over 8 weeks to assess its impact on anxiety, depression, quality of life, and PTSD symptoms.

If the initial results show significant benefits, the program may be refined and potentially lead to the creation of a Mindfulness-based Exercise Program Manual for broader use in supporting cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful exercise, quality of life, and survival: a mindfulness-based exercise program for women with breast cancer. Tacón, AM., McComb, J.[2015]

Mindfulness-Based Stress Reduction (MBSR) therapy significantly improved anxiety and depression scores in 106 breast cancer patients undergoing postoperative chemotherapy compared to a control group of 111 patients receiving routine nursing.

The MBSR intervention positively impacted the overall quality of life, particularly in psychological aspects, although it did not show significant effects on physiological health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research on Mindfulness-Based Stress Reduction in Breast Cancer Patients Undergoing Chemotherapy: An Observational Pilot Study. Wang, H., Yang, Y., Zhang, X., et al.[2023]

An eight-week study involving 63 participants compared the effects of Mindfulness Based Stress Reduction (MBSR) to an active control group (Health Enhancement Program) on sustained attention, but found no significant differences in improvement between the two groups.

While MBSR did not enhance sustained attention, there was some evidence of improved visual discrimination, suggesting that mindfulness training may have specific benefits, but further research is needed to clarify its effects on different aspects of attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. MacCoon, DG., MacLean, KA., Davidson, RJ., et al.[2022]

In a study of 1,146 older adults (aged 65+) over two years, those who engaged in high levels of exercise (aerobic exercise for at least 30 minutes, three or more times a week) were significantly less likely to experience cognitive decline, with an odds ratio of 0.39, indicating a protective effect.

Even when high exercise was defined as five or more days a week, both low and high exercise levels were associated with reduced risk of cognitive decline, suggesting that any level of regular physical activity may help in preventing cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise level and cognitive decline: the MoVIES project. Lytle, ME., Vander Bilt, J., Pandav, RS., et al.[2022]

In a study of 66 healthy adults, 8 weeks of aerobic exercise training (AET) significantly increased the time spent in moderate-to-vigorous physical activity (MVPA) compared to a no-treatment control, suggesting AET is effective for enhancing physical activity levels.

Mindfulness-based stress reduction (MBSR) training appeared to help mitigate the decrease in physical activity typically associated with shorter days and cooler weather, indicating its potential role in maintaining exercise participation during challenging seasonal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. Meyer, JD., Torres, ER., Grabow, ML., et al.[2020]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

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