Mind-body Exercise for Metabolic Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

The aim of this study is to assess the feasibility and acceptability (e.g., enrollment, adherence, retention, acceptability of procedures and interventions) of a pilot factorial study design that will help elucidate components of mind-body exercise interventions. The study involves completing a walking program, a mindful attention program, a walking program that includes mindful attention, or no program at all. A "pilot" study is a smaller study that helps researchers to understand whether the study design can be carried out and what participants think about the study.

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.

What data supports the effectiveness of the treatment Mind-body Exercise for Metabolic Syndrome?

Research shows that physical activity, including exercise with mindful attention, can improve outcomes for people with metabolic syndrome by enhancing insulin resistance and body composition, similar to the effects of some diabetes medications. Additionally, combining exercise with a healthy diet can help correct issues like high cholesterol and high blood pressure. ^{1 2 3 4 5}

Is mind-body exercise safe for humans?

Research shows that regular exercise, including mind-body exercises, is generally safe for humans and can improve various health conditions like obesity, diabetes, and metabolic syndrome. It can help reduce abdominal obesity, improve blood pressure, and enhance overall body composition without significant safety concerns. ^{3 6 7 8 9}

How does the mind-body exercise treatment for metabolic syndrome differ from other treatments?

Mind-body exercise for metabolic syndrome is unique because it combines physical activity with mindfulness practices, such as meditation and yoga, which not only improve physical health but also address psychological stress and enhance quality of life. This holistic approach is different from traditional treatments that may focus solely on physical aspects without considering mental well-being. ^{2 10 11 12 13}

Research Team

Eligibility Criteria

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

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

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Exercise (Behavioural Intervention)
• Exercise with mindful attention (Behavioural Intervention)
• Mindful attention (Behavioural Intervention)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth Israel Deaconess Medical Center Boston, MA

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Patients Recruited

12,930,000+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Physical activity behaviour in patients with metabolic syndrome. [2022]

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

Behavior Change Techniques Improve Adherence to Physical Activity Recommendations for Adults with Metabolic Syndrome: A Systematic Review. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

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

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Combined exercise training in men with metabolic syndrome after acute coronary event]. [2017]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

[Exercise therapy for patients with metabolic syndrome]. [2017]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

The effects of physical exercise therapy on weight control: its regulation of adipocyte physiology and metabolic capacity. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

The effects of exercise program on burnout and metabolic syndrome components in banking and insurance workers. [2022]

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

Application of the transtheoretical model: exercise behavior in Korean adults with metabolic syndrome. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Abdominal obesity and metabolic syndrome: exercise as medicine? [2022]

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

Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study. [2020]

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

Effect of meditation on endothelial function in Black Americans with metabolic syndrome: a randomized trial. [2022]

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

The metabolic syndrome and mind-body therapies: a systematic review. [2022]

13. Switzerland 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. [2023]