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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632487
• Other study ID #: IRB201501139
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 20, 2018

Study information

• Verified date: November 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 20, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Exercise
Center-based walking + balance, stretching, and light resistance
• Non-Exercise Physical Activity (NEPA)
Behavioral counseling paired with technology intervention to monitor physical activity

Locations

Country	Name	City	State
United States	UF Clinical Translational Research Building	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure between the groups		20 weeks
Secondary	Exercise capacity between the groups	distance on 6-minute walk test	20 weeks
Secondary	Waist circumference between the groups		20 weeks