Treadmill Exercise in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Treadmill Exercise in Metabolic Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03435315
• Other study ID #: 2018P000014
• Status: Terminated
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: October 20, 2021

Study information

• Verified date: May 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 20, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Treadmill Exercise- behavioral approach
12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
• Treadmill Exercise- traditional approach
12-session, 6-week traditional treadmill exercise program

Locations

Country	Name	City	State
United States	BIDMC	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility	% willing to be randomized	Through study completion, an average of 1 year
Primary	Protocol Adherence	% sessions attended	Through study completion, an average of 1 year
Secondary	Cardiopulmonary Dynamics	CardioPulmonary Exercise Testing (standard metabolic cart)	Weeks 1 and 6
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)