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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 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

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 more
Secondary study objectives
Emotion regulation
Heart rate dynamics
In-session heart rate
+9 more

Awards & 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

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,921 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
394 Patients Enrolled for Metabolic Syndrome

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05242640 — N/A
Metabolic Syndrome Research Study Groups: Mindful attention, Exercise, Exercise with mindful attention, No intervention
Metabolic Syndrome Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05242640 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05242640 — N/A
~6 spots leftby Apr 2025