Smart Television and Exercise Promotion for Independent Living Facilities (STEP4Life)

August 22, 2018 updated by: Klein Buendel, Inc.
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g., increased strength and balance, reduced frailty, fewer falls, improved brain function, lower mortality risk), yet many seniors have limited access to exercise options due to numerous barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This project will overcome common exercise barriers by creating an interactive web-enabled TV program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF residents and administrators will be able to create, use, and evaluate a customizable exercise program tailored to the individual's preferred type of exercise, intensity, and duration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Older Adults (OAs), aged 65 years and older, are the fastest growing segment of the U.S. population. As life expectancy increases, maintaining physical independence has become a public health priority. It is well recognized that regular physical activity (PA) can be done safely by seniors, and has multiple physical, emotional, and cognitive benefits. Yet, they remain the least physically active of any age group. This suggests that the translational reach of efficacious PA protocols to the real-world remains limited, and a need for research which is scalable to the individual in more naturalistic settings exists. An emerging trend for seniors is to choose Independent Living Facilities (ILFs) as their home. ILFs offer a variety of social, cultural, and fitness services. Access to up-to-date technologies (e.g., wireless Internet), web-based education, and wellness programs are a priority for ILF residents, thus opportunities for using technology for health promotion with OAs exists. ILFs provide a unique opportunity for PA promotion, because 1) more seniors are choosing ILFs for aging-in-place, 2) PA is of interest to ILF residents, 3) ILFs should continue to increase their wellness offerings, and 4) ILFs should be interested in incorporating PA programs into wellness offerings. Research is needed to translate efficacious PA protocols for seniors into formats that are scalable to OAs in real-world settings. The goal is to extrapolate knowledge gained from efficacy research to improve the utilization and sustainability of evidence-based methods by producing programs that are agreeable, user-friendly, and optimal at both the individual and organizational level. Smart Television and Exercise Promotion for Independent Living Facilities (STEP for LIFE) will establish the feasibility for translating an evidence-based PA program using an interactive web-enabled, streaming-video technology (i.e., Smart TV) for ILF residents. This program offers 1) an innovative and potentially effective medium to reach seniors, 2) the ability to select and sequence together a session that is personalized to fitness level, type of exercise, and duration, and 3) organizations the ability to provide desired wellness options which meet both resident and organizational needs. The purpose of this study is to provide the initial research for translating efficacious research-based PA protocols for seniors into a scalable format usable in a real-world ILF setting, and to gain knowledge at individual and organizational levels to improve implementation and sustainability of this evidence-based approach. Specific Aims include extensive formative research on the use, interest, and effectiveness of interactive multimedia approaches for promoting PA, and its integration into senior living settings. A working prototype will be developed and tested for usability with ILF residents and administrators, and seniors not residing in ILFs. Outcomes will establish the feasibility of producing and testing STEP for LIFE in a large-scale randomized trial. A larger trial can inform 1) future translation of PA promotion to other OA residential settings (e.g., assisted living, memory care, rural settings), and 2) sustainable implementation strategies for other evidence-based health promotion protocols for seniors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Independent Living Facility (ILF) Resident Inclusion Criteria:

  • 55 years of age or older
  • live in an ILF
  • able tor read and speak English
  • able to consent to participate
  • exercise 60 min or more a week (self-reported)

ILF Resident Exclusion Criteria:

  • under 55 years of age
  • not live in an ILF
  • unable to read and speak English
  • unable to consent to participate
  • exercise less than 60 minutes (self-reported)

Non-ILF Resident Inclusion Criteria:

  • 55 years of age or older
  • not live in an ILF
  • able to read and speak English
  • able to consent to participate
  • exercise 60 min or more a week (self-reported)

Non-ILF Resident Exclusion Criteria:

  • under 55 years of age
  • live in an ILF
  • unable to read and speak English
  • unable to consent to participate
  • exercise less than 60 minutes (self-reported)

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: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Usability Testing
Prototype testing
Other: Usability Testing
Usability testing of "ready made" workouts in a group format.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: After 1 hour usability session
Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
After 1 hour usability session

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valerie Myers, PhD', Klein Buendel, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21AG046670 (NIH)
  • 5R21AG046670 (NIH)
  • 0283 (OTHER: Klein Buendel, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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