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Stopped prior to enrolling anticipated sample size due to COVID-19
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill exercise | Active Comparator |
| |
| Treadmill exercise with behavioral techniques | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill Exercise- behavioral approach | Other | 12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking |
|
| 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 |
| 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 |
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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:
Between the ages of 18-65
No regular physical activity (≥ 3 or more days per week) for the past 3 months
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIDMC | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Treadmill Exercise- traditional approach | Other | 12-session, 6-week traditional treadmill exercise program |
|
| 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) |
| D009750 |
| Nutritional and Metabolic Diseases |