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

NCT ID: NCT02632487

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-11-20

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise

This group will receive 8 weeks of center-based exercise followed by recommendations to remain physically active.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

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).

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Non-Exercise Physical Activity (NEPA)

Intervention Type: BEHAVIORAL

Behavioral counseling paired with technology intervention to monitor physical activity

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

Non-Exercise Physical Activity (NEPA)

Behavioral counseling paired with technology intervention to monitor physical activity

Intervention Type: BEHAVIORAL

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;
• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Anton

Role: PRINCIPAL_INVESTIGATOR

Univesity of Florida

Locations

UF Clinical Translational Research Building

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201501139

Identifier Type: -

Identifier Source: org_study_id