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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04630561
Other study ID # 20-004586
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2020
Est. completion date March 19, 2024

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effect of a posture intervention on specific areas of daily function and health: physical, psychological, cognitive, social, and environmental characteristics.


Description:

This project promotes community health through postural movement to demonstrate strong physical and mental health benefits. Specifically, Great Posture, Great Health will address two of the top five priorities of general health concerns: 1) obesity and 2) mental health. First, obesity is on the rise although more individuals are meeting or exceeding the current federal physical activity guidelines based on the data provided by the US Department of Health and Human Services (2020). Obesity is a common problem in adults with all socioeconomic status and all races, except Asians. In fact, Asians have low rates of heart disease, asthma, cancer, and a longer life expectancy than other races, potentially due to health behaviors, environment, and stress coping strategies (Acciai et al., 2015). Therefore, we should not overlook the importance of stress coping strategies practiced in Asian countries on obesity. It is becoming more evident that chronic stress (such as elevated cortisol levels) and steroid-based medications are strongly associated with obesity and chronic diseases. It is critical to develop and validate community health strategies to address both priorities. Great Posture, Great Health will introduce one of the most common mind-body postural exercises practiced in Asian countries to a large and diverse population.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date March 19, 2024
Est. primary completion date March 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Participants must be physically capable (defined as easy to moderate physical activities daily at least 60 minutes). - Participants also must have a normal (18.5-24.9kg/m2) or overweight BMI (25-29.9kg/m2). - Participants must be able to speak, listen, read, and understand sentences written in English. Exclusion Criteria: - More than two risk factors for coronary artery disease (high blood pressure, high blood cholesterol level (LDL), family history (a close relative with heart disease), diabetes mellitus, chronic kidney disease - History of falls, osteoporosis, osteoarthritis, or orthopedic or neurological conditions (i.e., stroke) - Medications that cause dizziness or slow movement - Smoke - Body mass to height squared ratio greater than 30kg/m2 or less than 18.4kg/m2, blood pressure greater than 140/90 mmHg, or a history of heart conditions. - Individuals with progressive cognitive, neurologic disorders, cancer treatment, chronic heart failure, or unstable medical conditions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Postural Intervention Program
Dynamic warmup program designed to target several areas of physical and mental wellbeing.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thigh Strength Isometric measurement (Newtons) of quadriceps and hamstrings musculature 12-week differences (Pre- and Post-intervention measures)
Primary Posture Posture will be measured via the Posture Screen Mobile app. Displacement (mm) 12-week differences (Pre- and Post-intervention measures)
Primary Bone density Bone densiometry will be measured via quantitative ultrasound (Achilles EXPII, GE). T-score. 12-week differences (Pre- and Post-intervention measures)
Secondary PROMIS - Physical Activity Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome) 12-week differences (Pre- and Post-intervention measures)
Secondary PROMIS - Physical Function Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome) 12-week differences (Pre- and Post-intervention measures)
Secondary PROMIS - Pain Interference Patient Reported Outcomes from a computerized adaptive test (T-score; normative score is 1.0; higher score equates to a better outcome) 12-week differences (Pre- and Post-intervention measures)
Secondary Mindful Attention Awareness Scale (MAAS) Patient Reported Outcomes (Mean score range: 1-6; higher score equates to increased mindfulness) 12-week differences (Pre- and Post-intervention measures)
Secondary Perceived Stress Scale (PSS-10) Patient Reported Outcomes (Score range: 0-40; higher score equates to increased stress) 12-week differences (Pre- and Post-intervention measures)
Secondary Generalized Anxiety Disorder (GAD7) Patient Reported Outcomes (Score range: 0-21; higher score equates to increased anxiety) 12-week differences (Pre- and Post-intervention measures)
Secondary Patient Health Questionnaire Depression Scale (PHQ) Patient Reported Outcomes (Score range: 0-27; score of 10 or greater is considered major depression, 20 or more is severe major depression.) 12-week differences (Pre- and Post-intervention measures)
Secondary Sex Demographic co-variate. (M/F) Through study completion, an average of 1 year
Secondary Age Demographic co-variate (years) Through study completion, an average of 1 year
Secondary BMI Demographic co-variate (BMI index; kg/m^2) 12-week differences (Pre- and Post-intervention measures)
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