Reducing Sedentary Behavior vs. Increasing Physical Activity in Older Adults (RISE)

This study is a randomized trial that will compare the effects of two, 12-week activity interventions on patterns of physical activity, physical health, and quality of life measures in 40 older adults who are able to walk for exercise. One intervention will target 150 minutes per week of home-based moderate exercise (e.g. brisk walking), consistent with current recommendations. The other intervention will target a decrease in time spent in sedentary behaviors (e.g. sitting) of 60 minutes per day. Both interventions will wear an activity armband which will allow them to self-monitor their activity or sedentary behavior in real time using a smartphone. The armband will also provide objective data to an interventionist that will facilitate the intervention. The main outcome will be time spent in moderate exercise.

Study Overview

• Status: Completed
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Other: Moderate-to-vigorous activity group; Other: Reducing sedentary behavior group

Detailed Description

Specific Aims: This application proposes to randomize community-dwelling, older adults to one of two, 12-week activity interventions that target either increased moderate-to-vigorous physical activity (MVPA) or decreased sedentary behavior (SED). The primary aim of this research is to evaluate the effect of a behavioral intervention targeting decreased SED vs. increased MVPA on objectively monitored activity (minutes of SED and MVPA). The secondary aim is to evaluate the effect of the SED intervention vs. the MVPA intervention on functional and psychosocial outcomes. To the investigators knowledge, this research will provide unique experimental evidence that SED can be altered in an older adult population and will yield key pilot data on the expected effect size for an intervention targeting SED vs. MVPA.

Background: The older adult population is the least active age group in the U.S. by two distinct metrics: a lack of MVPA and a high rate of SED (sitting without any significant exertion). This represents a public health opportunity because engaging in 150 minutes of MVPA is known to improve the risk of morbidity, mortality, and physical function. SED has emerged as a risk factor for adverse outcomes, independent of MVPA, and observational studies indicate that more SED is linked to an increased risk of clinical outcomes (mortality, diabetes, and cardiovascular disease) and worse aging outcomes, e.g. physical function. However, there exists no experimental data comparing interventions to reduce SED vs. increase MVPA in older adults.

Summary of Methods: The investigators propose a 2-arm randomized trial that will target increasing MVPA (Get Active) vs. decreasing SED (Sit Less) among community-dwelling, older adults from the Pepper Center Mobility Registry. The intervention will consist of a combination of in-person (Weeks 1-4, 6, 8, 10) and phone-based (Weeks 5, 7, 9, 11) individual counseling and will utilize the BodyMedia® Fit System (wearable armband with technology interface) to provide real-time feedback on daily MVPA or SED, which can be used by the subjects to self-monitor and by the interventionist to improve adherence. Assessments at baseline and 12 weeks will include objectively monitored minutes of MVPA and SED by a blinded armband, physical function (short physical performance battery, 400 meter walk, grip strength, gait speed), and assessment of subjective MVPA, SED, physical function, and psychosocial outcomes by questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • Physical Activity and Weight Management Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥60 years
• Currently engage in <60 minutes of MVPA per week
• Ability to complete a 400 meter walk test without an assistive device
• Access to a computer and compatible smartphone (Andriod or iPhone) for the use of the BodyMedia® Fit System to monitor Moderate -to - Vigorous physical activity or sedentary behavior
• Ability to provide medical clearance to participate in this study from their primary care physician

Exclusion Criteria:

• Unable to provide informed consent
• Household member on study staff
• Current or planned enrollment in another physical activity or weight loss program
• Cardiovascular event (heart attack, stroke, heart failure, revascularization procedure) in the last 6 months
• Current use of beta-blockers or other medication that could affect heart rate
• Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
• Comorbid condition that would limit participation in exercise (e.g. uncontrolled hypertension, severe arthritis, use of a assistive mobility device, currently undergoing treatment for cancer)
• >3 alcoholic beverages per day

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Moderate-to-vigorous activity group; This group will target achieving the current recommendations for physical activity in older adults. This is 150 minutes of moderate-to-vigorous activity per week.	Other: Moderate-to-vigorous activity group; This group will be administered an individual, behavioral intervention using the BodyMedia armband to self-monitor physical activity. The prescription will be 150 minutes of moderate exercise (e.g. brisk walking) each week.
EXPERIMENTAL: Reducing sedentary behavior group; This group will target a 60 minute per day reduction in sedentary behavior using an objective activity monitor.	Other: Reducing sedentary behavior group; This intervention will use individual counseling and the the BodyMedia armband to self-monitor sedentary behavior. The goal will be to decrease time spent in sedentary behavior by 60 minutes each day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Objectively Monitored Sedentary Behavior	Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function (Short Physical Performance Battery [SPPB])	Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best).	Change from baseline to 12 weeks
Change in Objectively-monitored Moderate-to-vigorous Physical Activity	Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period.	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (ESTIMATE): May 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2016
• Last Update Submitted That Met QC Criteria: July 9, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: physical activity; older adults; sedentary behavior
• Other Study ID Numbers: Pitt Pepper 124078