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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Exercise; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • UF Clinical Translational Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise; This group will receive 8 weeks of center-based exercise followed by recommendations to remain physically active.	Behavioral: Exercise; Center-based walking + balance, stretching, and light resistance
Experimental: Exercise + Non-Exercise Physical Activity (NEPA); This group will receive 8 weeks of center-based exercise combined with behavioral counseling and a technology intervention designed to increase daily Exercise + Non-Exercise Physical Activity (NEPA).	Behavioral: Exercise; Center-based walking + balance, stretching, and light resistance; Behavioral: Non-Exercise Physical Activity (NEPA); Behavioral counseling paired with technology intervention to monitor physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure between the groups	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity between the groups	distance on 6-minute walk test	20 weeks
Waist circumference between the groups		20 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Stephen Anton, Univesity of Florida

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB201501139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No