Sit Less for Successful Aging

May 15, 2018 updated by: Andrea Hergenroeder, University of Pittsburgh

Sit Less for Successful Aging: A Sedentary Behavior Intervention for Older Adults in Independent Living Communities

The objective of this pilot study is to quantify patterns of activity and sedentary behavior in independent living residents and to collect preliminary data on the feasibility of reducing sedentary behavior using a 12-week, behavioral intervention in older adults. We will also measure the effects of reducing sedentary behavior on physical function, sleep, quality of life, energy/mood, pain and blood pressure. Participants will act as their own controls through the use of a double baseline period to examine stability of the physical activity and outcome measures.

Study Overview

Status

Completed

Conditions

Detailed Description

Aim 1: To measure the amount of sedentary time and ambulation (steps) in older adults residing in independent living communities.

Aim 2: To test the acceptability and effectiveness of a 12-week sedentary behavior intervention to decrease sitting and increase ambulation which will in turn improve physical function (primary outcome) as well as sleep, quality of life, energy/mood, pain and blood pressure (secondary outcomes) in independent living residents.

Background: Sedentary behavior, or sitting for prolonged periods during waking time, is identified as a health risk that is distinct from the failure to achieve sufficient physical activity. Older adults exhibit the greatest time in sedentary behavior which is concerning given its association with chronic disease and poorer physical function. Preliminary data suggest that individuals in long term care facilities may have even greater sedentary time due to personal factors and environment influences. Most often, exercise is targeted as a mechanism for ameliorating frailty in older adults; however, reduction in sedentary time may be a more appealing and realistic goal for improving health outcomes. Despite this, studies targeting sedentary time in older adults, particularly in those in independent living facilities, are lacking.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • Reside in an independent living facility
  • Ability to walk approximately 100 feet (length of a hallway) with or without an assistive device

Exclusion Criteria:

  • Unable to provide informed consent
  • Presence of a comorbid medical condition that would limit ability to stand and perform light activity (e.g. recent orthopedic injury/surgery involving the lower extremities, currently undergoing treatment for cancer,acute cardiovascular conditions)
  • Presence of a skin condition that would prohibit the use of an activity device attached with medical tape to the thigh (e.g. open wound on the thigh, skin infection on the lower extremity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedentary Behavior Intervention
A behavioral intervention that targets prolonged sitting and encourages frequent activity breaks.
This 12-week intervention targets a reduction in prolonged sitting and includes provision of a wrist-worn activity prompter and in-person group sessions with behavioral counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sedentary Behavior
Time Frame: Baseline to 12 weeks
Objectively measured minutes of sitting during waking hours measured using the ActivPAL physical activity monitor for a minimum of 5 days pre and post-intervention. The ActivPAL is a thigh-mounted, compact device that classifies an individual's free-living activity into time spent in sedentary, standing, and walking behaviors.
Baseline to 12 weeks
Steps per Day
Time Frame: Baseline to 12 weeks
The number of steps per day measured using the ActivPAL activity monitor. This monitor is worn for a minimum of 5 days before and after the intervention.
Baseline to 12 weeks
Short Physical Performance Battery
Time Frame: Baseline to 12 weeks
This performance-based measure of physical function is a battery of measures to assess standing balance, gait speed and lower extremity strength (time to complete five chair rises)
Baseline to 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a
Time Frame: Baseline to 12 weeks
This self-report measure of physical function has 10 questions that assess the ability to perform various activities that require physical capability.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea L Hergenroeder, PT, PhD, Assistant Professor, Department of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Actual)

October 3, 2017

Study Completion (Actual)

October 3, 2017

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 17020397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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