Treadmill Exercise in Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT03435315
• Recruitment Status: Terminated
• First Posted: February 19, 2018
• Last Update Posted: February 11, 2022
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Gloria Y. Yeh, Beth Israel Deaconess Medical Center

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
Metabolic Syndrome	Other: Treadmill Exercise- behavioral approach; Other: Treadmill Exercise- traditional approach	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Treadmill Exercise in Metabolic Syndrome
• Actual Study Start Date: January 9, 2019
• Actual Primary Completion Date: July 7, 2021
• Actual Study Completion Date: October 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Treadmill exercise	Other: Treadmill Exercise- traditional approach; 16-session, 8-week traditional treadmill exercise program
Experimental: Treadmill exercise with behavioral techniques	Other: Treadmill Exercise- behavioral approach; 16-session, 8-week treadmill exercise program utilizing behavioral techniques while walking

Outcome Measures

Primary Outcome Measures :

1. Recruitment Feasibility [ Time Frame: Through study completion, an average of 1 year ]
   % willing to be randomized
2. Protocol Adherence [ Time Frame: Through study completion, an average of 1 year ]
   % sessions attended

Secondary Outcome Measures :

1. Cardiopulmonary Dynamics [ Time Frame: Weeks 1, 4, and 8 ]
   CardioPulmonary Exercise Testing (standard metabolic cart)
2. Fatigue [ Time Frame: Week 0, week 4, week 9 ]
   Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
3. Global Health [ Time Frame: Week 0, week 4, week 9 ]
   PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
4. Psychological Symptoms [ Time Frame: Week 0, week 4, week 9 ]
   Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
5. Affect [ Time Frame: Week 0, week 4, week 9 ]
   Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
6. Anxiety Sensitivity [ Time Frame: Week 0, week 4, week 9 ]
   Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
7. Distress Tolerance [ Time Frame: Week 0, week 4, week 9 ]
   Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
8. Discomfort Intolerance [ Time Frame: Week 0, week 4, week 9 ]
   Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
9. Physical Activity Acceptance [ Time Frame: Week 0, week 4, week 9 ]
   Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
10. Exercise Self-Efficacy [ Time Frame: Week 0, week 4, week 9 ]
    Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
11. Exercise Motivation [ Time Frame: Week 0, week 4, week 9 ]
    Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
12. Exercise Barriers [ Time Frame: Week 0, week 4, week 9 ]
    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
13. Physical Activity [ Time Frame: Week 0, week 4, week 9 ]
    Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
14. Trait Mindfulness [ Time Frame: Week 0, week 4, week 9 ]
    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
15. State Mindfulness [ Time Frame: Weeks 1, 4, 8 ]
    State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
16. Interoceptive Awareness [ Time Frame: Week 0, week 4, week 9 ]
    Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

2. At risk for metabolic syndrome, defined as meeting two 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

Contacts and Locations

Locations

United States, Massachusetts

BIDMC

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

More Information

• Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03435315
• Other Study ID Numbers: 2018P000014
• First Posted: February 19, 2018
• Last Update Posted: February 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases