Mind-body Exercise for Metabolic Syndrome

Overseen By Kristen M Kraemer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Coronary artery disease, Diabetes, COPD, others

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

Compensation: Varies

Number of Visits: 16

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of mind-body exercises can assist individuals with metabolic syndrome, a condition marked by high blood sugar, high blood pressure, and unhealthy cholesterol levels. Participants will engage in one of three options: a walking program, a mindful attention program (mind-body therapy), or a combination of both, while some will not participate in any program. The trial aims to assess the practicality and reception of these programs. Individuals with metabolic syndrome who are not very active might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to investigate new methods for managing metabolic syndrome through innovative mind-body exercises.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking beta blockers or calcium channel blockers.

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

Research shows that both exercise and mindfulness practices are generally safe and well-tolerated by most people. Studies have found that regular physical activity can improve health, enhancing body shape and heart health, particularly in individuals with metabolic syndrome. Exercise remains safe for most people when they adhere to guidelines on intensity and duration.

Mindfulness, and its combination with exercise, also yields positive effects. Studies suggest that mindfulness practices can reduce insulin resistance and improve mental health. These practices are usually safe, with few reports of negative effects, making them suitable for most people.

In summary, the treatments in this study—exercise, mindfulness, and their combination—are supported by evidence showing they are safe and beneficial for individuals with metabolic syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mind-body exercise treatments for metabolic syndrome because they explore the power of combining physical and mental wellness. Unlike standard treatments, which often focus on medication and dietary changes, these methods incorporate mindful attention, which is known to enhance stress management and mental clarity. By using mindful audio recordings during exercise, the approach aims to improve engagement and potentially enhance the benefits of physical activity. This unique combination may offer a more holistic approach to managing metabolic syndrome, providing both physical and mental health benefits.

What evidence suggests that this trial's treatments could be effective for metabolic syndrome?

Research has shown that mindfulness practices, such as paying close attention to the present moment, can improve metabolic health. For instance, studies have found that mindfulness meditation can lower cholesterol, triglycerides, and blood sugar levels. In this trial, participants may receive mindful attention sessions to explore these benefits. Exercise, especially activities that elevate heart rate, can also enhance body shape and metabolic health in people with metabolic syndrome. Participants in this trial may engage in moderate-intensity treadmill walking to assess these effects. Combining exercise with mindfulness might amplify these benefits, as mindfulness can lead to better eating habits and lower blood sugar levels. This trial will also evaluate the combination of exercise with mindful attention. Overall, both exercise and mindfulness have strong evidence supporting their effectiveness in managing metabolic syndrome. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with Metabolic Syndrome, defined by specific criteria such as a BMI ≥ 25 and high blood pressure. Participants must be cleared for moderate exercise, have internet access, and be insufficiently active. Those on certain heart medications or with severe health conditions like heart disease or uncontrolled hypertension cannot join.

Inclusion Criteria

My doctor says I can do moderate exercise and stress tests.

Metabolic syndrome, defined as meeting 3 or more specific criteria in the last 12 months

Insufficiently active, defined as a low score on Godin-Shepard Leisure-Time Physical Activity Questionnaire

Exclusion Criteria

I have significant memory or thinking problems.

I have severe lung problems or COPD.

I have heart disease that makes exercise or heart rate variability tests unsafe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in one of the following: a walking program, a mindful attention program, a walking program with mindful attention, or no program at all

8 weeks

16 sessions (2x/week)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Exercise with mindful attention
• Mindful attention

Trial Overview The study tests the effectiveness of different programs: walking alone, mindful attention alone, both combined, or no program. It's a pilot study to see if these mind-body exercises are feasible and what participants think about them.

How Is the Trial Designed?

Group I: Mindful attention Experimental Treatment 1 Intervention

16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones

Group II: Exercise with mindful attention Experimental Treatment 1 Intervention

16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones

Group III: Exercise Experimental Treatment 1 Intervention

16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking

Group IV: No intervention Active Control 1 Intervention

No intervention sessions

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

In a study of 68 black Americans with metabolic syndrome, consciously resting meditation (CRM) showed improvements in endothelial function over 12 months, but these improvements were not significantly greater than those seen in a control group receiving health education.

CRM was associated with beneficial trends in metabolic syndrome risk factors, leading to a significant decrease in the overall risk factor score, suggesting potential health benefits beyond endothelial function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of meditation on endothelial function in Black Americans with metabolic syndrome: a randomized trial. Vaccarino, V., Kondwani, KA., Kelley, ME., et al.[2022]

Mind-body training, including mindfulness and yoga, has been shown to significantly reduce anxiety, depression, and stress levels in adults with type 2 diabetes mellitus (T2DM), based on a systematic review of eight randomized controlled trials.

The interventions varied in duration from 8 weeks to 6 months, with four studies showing significant improvements in anxiety and six demonstrating effectiveness in treating depression, highlighting the importance of integrating mental health care into diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mind-Body Training as a Mental Health Therapy in Adults with Diabetes Mellitus Type II: A Systematic Review. Ruiz-Ariza, B., Hita-Contreras, F., Rodríguez-López, C., et al.[2023]

Regular physical activity leads to significant metabolic and cardiovascular adaptations that can improve insulin resistance, which is crucial for managing metabolic syndrome.

Patient motivation and adherence to exercise therapy are essential for achieving positive treatment outcomes in individuals with metabolic syndrome, highlighting the need for a comprehensive approach to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise therapy for patients with metabolic syndrome]. Svacinová, H.[2017]

Regular exercise has been shown to effectively reduce abdominal obesity and improve body composition, which are key factors in managing metabolic syndrome, a condition affecting over 20% of adults globally.

There is moderate evidence supporting exercise programs as a treatment for metabolic syndrome, but the optimal type and amount of exercise needed for the best results is still unclear, highlighting the challenge of ensuring individuals stick to these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal obesity and metabolic syndrome: exercise as medicine? Paley, CA., Johnson, MI.[2022]

A study involving 24 patients with metabolic syndrome revealed that while most patients understand the benefits of physical activity, 62% were unaware of the specific recommendations from health authorities to exercise for half an hour daily at medium intensity.

Despite 87% of patients expressing motivation to increase their physical activity, many faced barriers such as lack of opportunities and guidance, highlighting the need for better communication of exercise recommendations and practical support for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity behaviour in patients with metabolic syndrome. Murer, M., Schmied, C., Battegay, E., et al.[2022]

In a study involving 95 patients (42 with metabolic syndrome and 53 without) after coronary intervention, both groups showed significant improvements in aerobic capacity and physical performance after 12 weeks of combined aerobic-resistance training.

Patients with metabolic syndrome experienced a more significant decrease in systolic blood pressure compared to those without metabolic syndrome, indicating that cardiovascular rehabilitation is beneficial for patients with multiple risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined exercise training in men with metabolic syndrome after acute coronary event]. Svacinová, H., Mrkvicová, V., Pochmonová, J., et al.[2017]

In a study of 210 adults with metabolic syndrome, over half were in the action and maintenance stages of regular exercise, indicating a significant portion are actively engaging in physical activity, which is beneficial for cardiovascular health.

Psychobehavioral strategies like consciousness raising, self-reevaluation, and self-liberation were linked to increased regular exercise behavior, suggesting that these strategies could be effective in promoting exercise among individuals with metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the transtheoretical model: exercise behavior in Korean adults with metabolic syndrome. Kim, CJ., Kim, BT., Chae, SM.[2017]

A three-month exercise program for banking and insurance workers significantly reduced burnout levels and improved components of metabolic syndrome, such as waist circumference and systolic blood pressure.

The study found a dose-response relationship, indicating that higher exercise intensity was associated with greater improvements in both burnout and metabolic syndrome components, highlighting the importance of exercise intensity in workplace health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exercise program on burnout and metabolic syndrome components in banking and insurance workers. Tsai, HH., Yeh, CY., Su, CT., et al.[2022]

Increased daily physical activity can prevent type 2 diabetes and help treat metabolic syndrome, showing effects on glycaemic control comparable to oral antidiabetic medications.

Exercise, whether endurance or strength training, improves insulin resistance and body composition, and when combined with a proper diet, can also help correct issues like dyslipidaemia and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical training in the treatment of metabolic syndrome]. Dela, F.[2017]

A systematic review of four randomized controlled trials involving 428 participants suggests that goal setting may improve adherence to physical activity recommendations for people with metabolic syndrome over three to six months, although the evidence is of very low certainty.

Self-monitoring and feedback strategies showed low certainty evidence of increasing adherence to physical activity interventions over 12 months, indicating that these behavior change techniques could be beneficial for managing metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Change Techniques Improve Adherence to Physical Activity Recommendations for Adults with Metabolic Syndrome: A Systematic Review. Peiris, CL., Gallagher, A., Taylor, NF., et al.[2023]

Mind-body therapies like yoga, tai chi, qigong, and meditation may help improve symptoms and physiological measures associated with metabolic syndrome, which increases the risk of serious health issues like type 2 diabetes and cardiovascular disease.

A systematic review identified three clinical trials that support the effectiveness of these mind-body practices as supportive care for managing metabolic syndrome, highlighting their potential benefits in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The metabolic syndrome and mind-body therapies: a systematic review. Anderson, JG., Taylor, AG.[2022]

Exercise is a crucial therapeutic strategy for managing obesity-related health issues, such as dyslipidemia, hypertension, and insulin resistance, which can worsen cardiovascular disease.

Physical activity not only aids in weight loss and maintenance but also helps lower blood pressure, cholesterol, and blood sugar levels, making it effective in treating and preventing metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical exercise therapy on weight control: its regulation of adipocyte physiology and metabolic capacity. Park, HJ., Rhie, SJ., Shim, I.[2023]

A 12-week yoga program combined with health education significantly improved quality of life in adults at risk for metabolic syndrome, particularly in physical role and general health perceptions.

This study is the first to explore the unique benefits of yoga alongside lifestyle education for metabolic syndrome, suggesting that yoga may help address psychological stress and enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study. Sohl, SJ., Wallston, KA., Watkins, K., et al.[2020]

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A Systematic Review with Meta-Analysis of Clinical Trials The main results of the review are that regardless of the type of exercise, a reduction in the indicators of metabolic syndrome is possible; ...

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