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Treadmill Exercise in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03435315
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gloria Y. Yeh, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Treadmill Exercise- behavioral approach Other: Treadmill Exercise- traditional approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435315


Contacts
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Contact: Gloria Yeh, MD, MPH 617-754-1419 gyeh@bidmc.harvard.edu
Contact: Kristen Kraemer, PhD 617-7541443 kkraemer@bidmc.harvard.edu

Locations
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United States, Massachusetts
BIDMC Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

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Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03435315     History of Changes
Other Study ID Numbers: 2018P000014
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases