Treadmill Exercise in Metabolic Syndrome

Beth Israel Lahey Health

Status: Terminated

Conditions: Metabolic Syndrome

Treatments: Other: Treadmill Exercise- behavioral approach; Other: Treadmill Exercise- traditional approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03435315

2018P000014

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Referred by healthcare provider and given medical clearance for moderate-intensity exercise

2. 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

3. Between the ages of 18-65

4. No regular physical activity (≥ 3 or more days per week) for the past 3 months

Exclusion criteria

1. 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)
2. Confirmed diagnosis of coronary artery disease
3. Confirmed diagnosis of diabetes
4. Currently taking a beta blocker or calcium channel blocker medication
5. Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
6. Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
7. Self-reported psychotic disorder
8. 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.
9. Non-English speaking

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Treadmill exercise

Active Comparator group

Treatment:

Other: Treadmill Exercise- traditional approach

Treadmill exercise with behavioral techniques

Experimental group

Treatment:

Other: Treadmill Exercise- behavioral approach