Treadmill Exercise in Metabolic Syndrome

NCT ID: NCT03435315

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2021-10-20

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Treadmill exercise

Group Type: ACTIVE_COMPARATOR

Treadmill Exercise- traditional approach

Intervention Type: OTHER

12-session, 6-week traditional treadmill exercise program

Treadmill exercise with behavioral techniques

Group Type: EXPERIMENTAL

Treadmill Exercise- behavioral approach

Intervention Type: OTHER

12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking

Interventions

Treadmill Exercise- behavioral approach

12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking

Intervention Type: OTHER

Treadmill Exercise- traditional approach

12-session, 6-week traditional treadmill exercise program

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gloria Y. Yeh

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BIDMC

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P000014

Identifier Type: -

Identifier Source: org_study_id