Clinical trial NCT03435315: Treadmill Exercise in Metabolic Syndrome
Official title: Treadmill Exercise in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: Through study completion, an average of 1 year
measure: Protocol Adherence
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Cardiopulmonary Dynamics
timeFrame: Weeks 1 and 6
measure: Fatigue
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Global Health
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Psychological Symptoms
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Affect
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Anxiety Sensitivity
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Distress Tolerance
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Discomfort Intolerance
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Physical Activity Acceptance
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Exercise Self-Efficacy
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Exercise Motivation
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Exercise Barriers
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Physical Activity
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: Trait Mindfulness
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
measure: State Mindfulness
timeFrame: Weeks 1, 3, 6
measure: Interoceptive Awareness
timeFrame: Week 0, week 3, post-intervention (after 6 week intervention)
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
References: