Treadmill Exercise in Metabolic Syndrome

NCT03435315 | Terminated

• 1 other identifier: 2018P000014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Cardiopulmonary Dynamics

  Weeks 1 and 6

• Fatigue

  Week 0, week 3, post-intervention (after 6 week intervention)

• Global Health

  Week 0, week 3, post-intervention (after 6 week intervention)

• Psychological Symptoms

  Week 0, week 3, post-intervention (after 6 week intervention)

• Affect

  Week 0, week 3, post-intervention (after 6 week intervention)

Study Arms (2)

Treadmill exercise

ACTIVE COMPARATOR

Other: Treadmill Exercise- traditional approach

Treadmill exercise with behavioral techniques

EXPERIMENTAL

Other: Treadmill Exercise- behavioral approach

Interventions

Treadmill Exercise- behavioral approach OTHER

12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking

Treadmill exercise with behavioral techniques

Treadmill Exercise- traditional approach OTHER

12-session, 6-week traditional treadmill exercise program

Treadmill exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 19, 2018
• Study Start: January 9, 2019
• Primary Completion: July 7, 2021
• Study Completion: October 20, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)