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Sit Less for Successful Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537677
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Hergenroeder, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Reduction in Sedentary Behavior Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sit Less for Successful Aging: A Sedentary Behavior Intervention for Older Adults in Independent Living Communities
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sedentary Behavior Intervention
A behavioral intervention that targets prolonged sitting and encourages frequent activity breaks.
Behavioral: Reduction in Sedentary Behavior
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537677


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Andrea L Hergenroeder, PT, PhD Assistant Professor, Department of Physical Therapy
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Responsible Party: Andrea Hergenroeder, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03537677    
Other Study ID Numbers: 17020397
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No