Treadmill Exercise in Metabolic Syndrome
- Conditions
- Metabolic Syndrome
- Interventions
- Other: Treadmill Exercise- traditional approachOther: Treadmill Exercise- behavioral approach
- Registration Number
- NCT03435315
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treadmill exercise Treadmill Exercise- traditional approach - Treadmill exercise with behavioral techniques Treadmill Exercise- behavioral approach -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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 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
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
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
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
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
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
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
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
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
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
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
Trial Locations
- Locations (1)
BIDMC
🇺🇸Boston, Massachusetts, United States