Treadmill Exercise in Metabolic Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treadmill exercise
|
Other: Treadmill Exercise- traditional approach
12-session, 6-week traditional treadmill exercise program
|
| Experimental: Treadmill exercise with behavioral techniques
|
Other: Treadmill Exercise- behavioral approach
12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
|
Outcome Measures
Primary Outcome Measures
- Recruitment Feasibility [Through study completion, an average of 1 year]
% willing to be randomized
- Protocol Adherence [Through study completion, an average of 1 year]
% sessions attended
Secondary Outcome Measures
- Cardiopulmonary Dynamics [Weeks 1 and 6]
CardioPulmonary Exercise Testing (standard metabolic cart)
- Fatigue [Week 0, week 3, post-intervention (after 6 week intervention)]
Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
- Global Health [Week 0, week 3, post-intervention (after 6 week intervention)]
PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
- Psychological Symptoms [Week 0, week 3, post-intervention (after 6 week intervention)]
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
- Affect [Week 0, week 3, post-intervention (after 6 week intervention)]
Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
- Anxiety Sensitivity [Week 0, week 3, post-intervention (after 6 week intervention)]
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
- Distress Tolerance [Week 0, week 3, post-intervention (after 6 week intervention)]
Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
- Discomfort Intolerance [Week 0, week 3, post-intervention (after 6 week intervention)]
Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
- Physical Activity Acceptance [Week 0, week 3, post-intervention (after 6 week intervention)]
Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
- Exercise Self-Efficacy [Week 0, week 3, post-intervention (after 6 week intervention)]
Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
- Exercise Motivation [Week 0, week 3, post-intervention (after 6 week intervention)]
Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
- Exercise Barriers [Week 0, week 3, post-intervention (after 6 week intervention)]
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
- Physical Activity [Week 0, week 3, post-intervention (after 6 week intervention)]
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
- Trait Mindfulness [Week 0, week 3, post-intervention (after 6 week intervention)]
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
- State Mindfulness [Weeks 1, 3, 6]
State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
- Interoceptive Awareness [Week 0, week 3, post-intervention (after 6 week intervention)]
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BIDMC | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018P000014