NCT03537677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

May 15, 2018

Last Update Submit

May 15, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Sedentary Behavior

    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

    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

    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

    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

Study Arms (1)

Sedentary Behavior Intervention

EXPERIMENTAL

A behavioral intervention that targets prolonged sitting and encourages frequent activity breaks.

Behavioral: Reduction in Sedentary Behavior

Interventions

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.

Sedentary Behavior Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Andrea L Hergenroeder, PT, PhD

    Assistant Professor, Department of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

May 9, 2017

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

May 25, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations