Treadmill Exercise in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to better understand the effects of two types of treadmill exercise programs that include education and/or techniques that may be helpful for exercise among individuals with, or at risk for, metabolic syndrome.

Official Title
-----------------
Treadmill Exercise in Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Treadmill Exercise- behavioral approach
* Other: Treadmill Exercise- traditional approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred by healthcare provider and given medical clearance for moderate-intensity exercise Metabolic syndrome, defined as meeting three or more of the following criteria: Obesity or overweight defined as BMI > 25 Impaired glycemia (fasting blood sugar of ≥ 100 [5.6 mmol/L] or glycated hemoglobin [A1C] of ≥ 5.7) Increased blood pressure (130/85 mmHg or higher) or if you take medicine for high blood pressure Increased fasting levels of triglycerides (≥ 150 or 1.7 mmol/L) or decreased fasting high-density lipoprotein (HDL) cholesterol (less than 40 mg/dL or 1 mmol/L for men or 50 mg/dL or 1.3 mmol/L for women) or if you take any medicines for dyslipidemia Between the ages of 18-65 No regular physical activity (≥ 3 or more days per week) for the past 3 months Exclusion Criteria: Contraindications for treadmill exercise determined by their physician (e.g., cardiopulmonary limitations or diagnoses) or other inability to do treadmill exercise (e.g., musculoskeletal restrictions or severe balance impairment) Confirmed diagnosis of coronary artery disease Confirmed diagnosis of diabetes Currently taking a beta blocker or calcium channel blocker medication Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90 Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma) Self-reported psychotic disorder Current practice of mindfulness mediation or mindful movement (e.g., yoga or tai chi), defined as regular daily practice or >2 classes or self-guided sessions per week in the past three months. Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treadmill exercise<br> | Other: Treadmill Exercise- traditional approach<br>* 12-session, 6-week traditional treadmill exercise program<br>|
| Experimental: Treadmill exercise with behavioral techniques<br> | Other: Treadmill Exercise- behavioral approach<br>* 12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Feasibility | % willing to be randomized | Through study completion, an average of 1 year | 
| Protocol Adherence | % sessions attended | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary Dynamics | CardioPulmonary Exercise Testing (standard metabolic cart) | Weeks 1 and 6 | 
| Fatigue | Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Global Health | PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Psychological Symptoms | Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Affect | Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Anxiety Sensitivity | Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Distress Tolerance | Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Discomfort Intolerance | Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Physical Activity Acceptance | Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Exercise Self-Efficacy | Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Exercise Motivation | Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Exercise Barriers | Exercise Benefits and Barriers Scale; 2 subscales; Exercise benefits subscale score range: 29-116, higher scores = higher perceived benefit from exercise; Exercise barriers subscale score range: 14-56, higher scores = higher perceived barriers to exercise | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Physical Activity | Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time | Week 0, week 3, post-intervention (after 6 week intervention) | 
| Trait Mindfulness | Five Facet Mindfulness Questionnaire; 5 subscales; Observe subscale score range: 8-40, higher scores = greater observing skills; Describe subscale score range: 8-40, higher scores = greater describing skills; Acting with Awareness subscale score range: 8-40, higher scores = greater awareness skills; Nonjudgment subscale score range: 8-40, higher scores = greater nonjudgment skills; Nonreactivity subscale score range: 7-35, higher scores = greater nonreactivity skills | Week 0, week 3, post-intervention (after 6 week intervention) | 
| State Mindfulness | State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness | Weeks 1, 3, 6 | 
| Interoceptive Awareness | Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better | Week 0, week 3, post-intervention (after 6 week intervention) |