Utilizing Tailored Step-Count Feedback to Enhance Physical Activity in the Elderly (StepCount)

May 27, 2015 updated by: Scott J. Strath, University of Wisconsin, Milwaukee
Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

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

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Physical Activity & Health Research Laboratory

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

Ages Eligible for Study

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female individuals living in the community.
  2. Aged between 50 and 85 years, at screening.
  3. Sufficient physical function not to have limitations to participate in physical activity demonstrated by:

    • Habitual gait speed ≥ 1.5 mph, AND
    • No use of a cane or walker, AND
    • Able to walk ≥ 50 feet unaided
  4. Sufficient cognitive function, as demonstrated by responses to the mini-mental state examination(>23 score).
  5. Be able to read and write in English
  6. Sedentary behavior, demonstrated by no regular activity / exercise for previous 6 months and/or a Stage of Change 2 and 3

Exclusion Criteria:

  1. Presence of a rapidly progressive or terminal illness condition that is expected to result in significant functional decline during the course of the proposed studies.
  2. Significant uncontrolled cardiovascular disease and conditions, e.g. unstable or new onset angina, unrepaired aortic aneurysms, critical aortic stenosis or CAD without bypass, persistent moderate to severe uncontrolled hypertension.
  3. Significant uncontrolled metabolic disease, e.g. hemoglobin A1c levels greater than 8.0 and/or glucose levels greater than 300 mg/dL.
  4. Fracture of lower extremity within three months.
  5. Amputation other than toes.
  6. Current history of severe arthritis or orthopedic condition precluding physical activity.
  7. Participation in any regular structured exercise (resistance training, Tai Chi, high intensity walking, jogging, cycling, stair climbing, stepping, within the previous 6 months.
  8. Individuals that start a new medication that can impact health variables examined during study period (e.g., beta blockers, glucose or cholesterol altering medications), or individuals who alter medication dose that can impact health variables examined within study period.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Active Comparator: 10,000 Steps Group
Each participant randomized to this study arm will receive a pedometer and a generic recommendation to accumulate 10,000 Steps per Day.
The testing of a web mediated step intervention designed to set weekly step targets, and channel participants through a series of motivational screens depending on compliance or non-compliance with set step goals.
Experimental: Web Mediated Step Group
Participants randomized to this study arm receive an introduction to the study website. Each person utilizes the website to track their daily physical activity steps. Goals are given on a weekly basis to increase steps by 10% per day per week over baseline values. The website channels each participant through a series of motivational messages designed to increase compliance with recommended physical activity targets
The testing of a web mediated step intervention designed to set weekly step targets, and channel participants through a series of motivational screens depending on compliance or non-compliance with set step goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objectively assessed steps per day
Time Frame: 12 weeks
Pedometer determined physical activity
12 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Scott J Strath, PhD, University of Wisconsin, Milwaukee

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

August 1, 2009

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • StepCount
  • K01AG025962 (U.S. NIH Grant/Contract)

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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