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Clinical Trials/NCT02632487
NCT02632487
Completed
Not Applicable

Wearable Technology to Reduce Sedentary Behavior and CVD Risk in Older Adults

University of Florida1 site in 1 country58 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
University of Florida
Enrollment
58
Locations
1
Primary Endpoint
Blood pressure between the groups
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (NEPA).

Detailed Description

A recruitment of 40 sedentary men and women ≥ 60 years of age with elevated cardiovascular risk and follow them for 20 weeks. Participants will be randomly assigned (n = 20/group) to 1) an 8-week, twice-weekly, multi-modal, center-based exercise intervention (EX) followed by 12 additional weeks of follow-up assessment, or 2) the same intervention with participants also asked to wear a validated lightweight activity tracker on their hip during waking hours and instructed on how to reduce sedentary behavior increase NEPA within their daily routines (EX + NEPA). Evaluations will be done to 1) the extent to which EX + NEPA modifies sedentary behavior, 2) the impact of the interventions on cardiovascular risk factors, including blood pressure, exercise capacity, waist circumference, and circulating biomarkers, and 3) develop and optimize study procedures to guide the future trial.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
November 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Sedentary lifestyle, defined as \<150 min/wk of moderate physical activity by CHAMPS questionnaire
  • Moderate to high-risk of CHD events according to ATP-III risk classification algorithm
  • Willingness to be randomized to either intervention group
  • Willingness to participate in all study procedures

Exclusion Criteria

  • Failure to provide informed consent;
  • Regular participation in an exercise training program within the last 3 months
  • Absolute contraindication(s) to exercise training (American College of Sports Medicine guidelines)
  • Office SBP \> 180 mm Hg or DBP \> 110 mm Hg
  • Severe cardiac disease, i.e. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
  • Myocardial infarction or stroke within past year
  • Significant cognitive impairment, i.e. known dementia or a Mini-Mental State Examination score \< 24
  • Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, ALS;
  • Severe rheumatologic/orthopedic disease, e.g., awaiting joint replacement, active inflammatory disease
  • Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen;

Outcomes

Primary Outcomes

Blood pressure between the groups

Time Frame: 20 weeks

Secondary Outcomes

  • Waist circumference between the groups(20 weeks)
  • Exercise capacity between the groups(20 weeks)

Study Sites (1)

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