RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-31

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05242640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 12 months at the time of medical record review: (a) BMI ≥ 25; (b) fasting glucose ≥ 100 \[5.6 mmol/L\] or A1C ≥ 5.7 or medications; (c) blood pressure ≥ 130 systolic or ≥ 85 diastolic or medications; (d) triglycerides ≥ 150 or 1.7 mmol/L or medications; (e) or HDL \< 40mg/ dL for men and 50mg/dL for women or medications; * insufficiently active, defined as a score ≤ 23 (moderate-to-strenuous units) on Godin-Shepard Leisure-Time Physical Activity Questionnaire; * age 18-70 years; * given medical clearance for moderate-intensity exercise and exercise stress testing by their primary care physician (PCP); * access to a device with internet and videoconferencing capabilities	* current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure) in which exercise would be contraindicated or that would preclude HRV analyses (e.g., some arrhythmias); (b) any diabetes; (c) chronic obstructive pulmonary disease or other severe lung dysfunction (e.g., severe asthma); (d) severe cognitive impairment * \>2 self-reported classes or self-guided mindfulness or mindful movement sessions per week in past 3 months * self-reported inability to speak and read in English * current beta blocker or calcium channel blocker medication * uncontrolled hypertension, defined as resting blood pressure ≥ 150 systolic or ≥ 90 diastolic in the last 6 months * self- or physician-reported contraindications for exercise (e.g., severe balance impairment, musculoskeletal restrictions)

Inclusion Criteria

Exclusion Criteria

* Metabolic syndrome, defined as meeting 3 or more of the following criteria in the last 12 months at the time of medical record review: (a) BMI ≥ 25; (b) fasting glucose ≥ 100 \[5.6 mmol/L\] or A1C ≥ 5.7 or medications; (c) blood pressure ≥ 130 systolic or ≥ 85 diastolic or medications; (d) triglycerides ≥ 150 or 1.7 mmol/L or medications; (e) or HDL \< 40mg/ dL for men and 50mg/dL for women or medications;
* insufficiently active, defined as a score ≤ 23 (moderate-to-strenuous units) on Godin-Shepard Leisure-Time Physical Activity Questionnaire;
* age 18-70 years;
* given medical clearance for moderate-intensity exercise and exercise stress testing by their primary care physician (PCP);
* access to a device with internet and videoconferencing capabilities

* current diagnosis of any of the following: (a) coronary artery disease or other chronic heart diseases (e.g., heart failure) in which exercise would be contraindicated or that would preclude HRV analyses (e.g., some arrhythmias); (b) any diabetes; (c) chronic obstructive pulmonary disease or other severe lung dysfunction (e.g., severe asthma); (d) severe cognitive impairment
* \>2 self-reported classes or self-guided mindfulness or mindful movement sessions per week in past 3 months
* self-reported inability to speak and read in English
* current beta blocker or calcium channel blocker medication
* uncontrolled hypertension, defined as resting blood pressure ≥ 150 systolic or ≥ 90 diastolic in the last 6 months
* self- or physician-reported contraindications for exercise (e.g., severe balance impairment, musculoskeletal restrictions)

Contacts and Locations

Study Contact

Kristen M Kraemer, PhD

CONTACT

617-754-1443

kkraemer@bidmc.harvard.edu

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-31

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-01-31

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Metabolic Syndrome