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Mind-body Exercise for Metabolic Syndrome
N/A
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a walking and mindfulness program can help people and what they think of the study.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-invasive interventions like exercise and mindfulness training, significant side effects are not expected. However, typical exercise-related discomforts may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of interventions
Acceptability of study design
Feasibility of enrollment: eligible to enrollment ratio
+5 moreSecondary study objectives
Emotion regulation
Heart rate dynamics
In-session heart rate
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Mindful attentionExperimental Treatment1 Intervention
16 sessions over 8 weeks (2x/week) of mindful attention audio recordings delivered via headphones
Group II: Exercise with mindful attentionExperimental Treatment1 Intervention
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking utilizing mindful attention audio recordings delivered via headphones
Group III: ExerciseExperimental Treatment1 Intervention
16 sessions over 8 weeks (2x/week) of moderate-intensity treadmill walking
Group IV: No interventionActive Control1 Intervention
No intervention sessions
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,786 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
394 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am currently taking beta blocker or calcium channel blocker medication.My blood pressure has been stable for the last 6 months.I have been diagnosed with diabetes.I have participated in mindfulness sessions more than twice a week for the last 3 months.My doctor says I can do moderate exercise and stress tests.I am between 18 and 70 years old.I cannot speak or read English.
Research Study Groups:
This trial has the following groups:- Group 1: Mindful attention
- Group 2: Exercise
- Group 3: Exercise with mindful attention
- Group 4: No intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.