Treadmill Exercise in Metabolic Syndrome

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.

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Treadmill Exercise- traditional approach; Other: Treadmill Exercise- behavioral approach

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • BIDMC

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treadmill exercise	Other: Treadmill Exercise- traditional approach; 12-session, 6-week traditional treadmill exercise program
Experimental: Treadmill exercise with behavioral techniques	Other: Treadmill Exercise- behavioral approach; 12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	% willing to be randomized	Through study completion, an average of 1 year
Protocol Adherence	% sessions attended	Through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 2018P000014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No