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OpenTrials
Completed

NCT Number: NCT02632487

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

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).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Clinical Translational Research Building

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
  • Other significant co-morbid conditions that would impair ability to participate in the intervention
  • Simultaneous participation in another intervention trial

Treatment and study plan

Exercise

Behavioral

Center-based walking + balance, stretching, and light resistance

Non-Exercise Physical Activity (NEPA)

Behavioral

Behavioral counseling paired with technology intervention to monitor physical activity

Primary outcomes

  1. Blood pressure between the groups

    Time frame: 20 weeks

Secondary outcomes

  1. Exercise capacity between the groups

    Time frame: 20 weeks

    distance on 6-minute walk test

  2. Waist circumference between the groups

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 16, 2015
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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