Back to resultsTreadmill Exercise in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill Exercise- behavioral approach
Treadmill Exercise- traditional approach
Sponsored by
About this trial
This is an interventional other trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- BIDMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treadmill exercise
Treadmill exercise with behavioral techniques
Arm Description
Outcomes
Primary Outcome Measures
Recruitment Feasibility
% willing to be randomized
Protocol Adherence
% sessions attended
Secondary Outcome Measures
Cardiopulmonary Dynamics
CardioPulmonary Exercise Testing (standard metabolic cart)
Fatigue
Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
Global Health
PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
Psychological Symptoms
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
Affect
Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
Anxiety Sensitivity
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
Distress Tolerance
Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
Discomfort Intolerance
Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
Physical Activity Acceptance
Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
Exercise Self-Efficacy
Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
Exercise Motivation
Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
Exercise Barriers
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
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
Trait Mindfulness
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
State Mindfulness
State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
Interoceptive Awareness
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
Full Information
NCT ID
NCT03435315
First Posted
January 23, 2018
Last Updated
May 20, 2022
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03435315
Brief Title
Treadmill Exercise in Metabolic Syndrome
Official Title
Treadmill Exercise in Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped prior to enrolling anticipated sample size due to COVID-19
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
October 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadmill exercise
Arm Type
Active Comparator
Arm Title
Treadmill exercise with behavioral techniques
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Treadmill Exercise- behavioral approach
Intervention Description
12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
Intervention Type
Other
Intervention Name(s)
Treadmill Exercise- traditional approach
Intervention Description
12-session, 6-week traditional treadmill exercise program
Primary Outcome Measure Information:
Title
Recruitment Feasibility
Description
% willing to be randomized
Time Frame
Through study completion, an average of 1 year
Title
Protocol Adherence
Description
% sessions attended
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Cardiopulmonary Dynamics
Description
CardioPulmonary Exercise Testing (standard metabolic cart)
Time Frame
Weeks 1 and 6
Title
Fatigue
Description
Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Global Health
Description
PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Psychological Symptoms
Description
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Affect
Description
Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Anxiety Sensitivity
Description
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Distress Tolerance
Description
Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Discomfort Intolerance
Description
Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Physical Activity Acceptance
Description
Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Exercise Self-Efficacy
Description
Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Exercise Motivation
Description
Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Exercise Barriers
Description
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
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Physical Activity
Description
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
Trait Mindfulness
Description
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
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
Title
State Mindfulness
Description
State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
Time Frame
Weeks 1, 3, 6
Title
Interoceptive Awareness
Description
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
Time Frame
Week 0, week 3, post-intervention (after 6 week intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
BIDMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Treadmill Exercise in Metabolic Syndrome
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