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Completed

NCT Number: NCT03537677

Sit Less for Successful Aging

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.

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Key information

Conditions

Sedentary Lifestyle Behavior Sedentary Behavior

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Reduction in Sedentary Behavior

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 25, 2018
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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