Resilience Training for Age-related Cognitive Decline

(MEDEX-2 Trial)

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

468 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for age-related cognitive decline?

Research shows that Mindfulness-Based Stress Reduction (MBSR) and exercise programs can improve health and well-being, and they have been effective in reducing anxiety and depression in cancer patients. These components may also help with age-related cognitive decline by promoting mental and physical health. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for humans and has been used to help with stress, anxiety, depression, and various chronic illnesses. It is a meditation program that has been adapted for different settings, including healthcare staff, and is recommended for its mental health benefits. ^{1 5 6 7 8}

How does the Resilience Training for Age-related Cognitive Decline treatment differ from other treatments for cognitive decline?

This treatment is unique because it combines physical exercise, health education, and mindfulness-based stress reduction, which together may enhance both physical and cognitive resilience in older adults. Unlike standard treatments that might focus on medication or single interventions, this approach integrates multiple activities to potentially improve overall brain health and delay cognitive decline. ^{9 10 11 12 13}

What is the purpose of this trial?

This project capitalizes on a natural experiment imposed by the COVID-19 pandemic in conjunction with an extensive set of cognitive, emotional, biological, and neuroimaging variables already collected at multiple time points in older adults participating in a clinical trial of exercise and mindfulness. This project will elucidate the effects of stress on cognitive function and emotional health in later life, including biological measures of Alzheimer Disease risk, stress, and aging, with the ultimate goal of discovering how to mitigate these effects, among older adults who have made and maintained a lifestyle change.

Research Team

Eric Lenze, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

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

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. [2020]

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

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

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

Research on Mindfulness-Based Stress Reduction in Breast Cancer Patients Undergoing Chemotherapy: An Observational Pilot Study. [2023]

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

Mindfulness-based stress reduction and cancer: a meta-analysis. [2022]

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

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

6. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

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

No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. [2022]

8. India pubmed.ncbi.nlm.nih.gov

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

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

Exercise level and cognitive decline: the MoVIES project. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The impact of exercise on the cognitive functioning of healthy older adults: a systematic review and meta-analysis. [2022]

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

Physical and cognitive activity and exercise for older adults: a review. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Can exercise prevent cognitive decline? [2022]

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

From bedside to bench: does mental and physical activity promote cognitive vitality in late life? [2006]