- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537677
Sit Less for Successful Aging
Sit Less for Successful Aging: A Sedentary Behavior Intervention for Older Adults in Independent Living Communities
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15219
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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.
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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
|
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Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a
Time Frame: Baseline to 12 weeks
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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
Sponsor
Investigators
- Principal Investigator: Andrea L Hergenroeder, PT, PhD, Assistant Professor, Department of Physical Therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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