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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

Study 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.Check my eligibility

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.See study design

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of interventions

Acceptability of study design

Feasibility of enrollment: eligible to enrollment ratio

+5 more

Secondary outcome measures

Emotion regulation

Heart rate dynamics

In-session heart rate

+9 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

838 Previous Clinical Trials

13,010,452 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications do I need to satisfy in order to join this clinical experiment?

"This research trial is looking to recruit forty participants who suffer from metabolic syndrome, as well as meet the following qualifications: a Body Mass Index (BMI) of over 30; Fasting Glucose levels higher than 5.6 mmol/L or A1C scores above 5.7, hypertension with systolic readings at 130 mmHg and diastolic readings at 85mmHG; Triglyceride levels exceeding 150mg/dL; HDL values under 40 mg/dL for men and 50mg/dLS for women. In addition, these candidates must be between 18-70 years old, cleared by their primary"

Answered by AI

What is the current enrollment count for this experiment?

"Affirmative. According to records maintained on clinicaltrials.gov, this medical experiment is currently open for recruitment, with the original post date being November 1st 2022 and a recent update occurring 16 days later. 40 individuals are required from one site in order to proceed."

Answered by AI

Are those older than 20 years eligible to partake in this experiment?

"This research team is currently recruiting individuals who are aged 18 or above, but younger than 70 years old."

Answered by AI

What are the ultimate objectives of this experiment?

"The primary efficacy metric which will be tracked over a 6 month period is the Acceptability of interventions. Secondary outcomes include In-session oxygen consumption, Self-efficacy as measured by Multidimensional Self-Efficacy Scale and Emotion regulation evaluated using Difficulties in Emotion Regulation Scale with six subscales scores."

Answered by AI

Is this investigation open to recruitment at the moment?

"Affirmative, the details provided on clinicaltrials.gov attest that this study is still soliciting participants. It was first published on November 1st 2022 and had its most recent update 16 days later. Forty people are required for enrolment at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome

Kristen Kraemer 2023. "Understanding Components of Mind-body Exercise for Physical Activity Engagement in Metabolic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05242640.

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