- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01158638
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
Conditions
Intervention / Treatment
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
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Wisconsin
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Milwaukee, Wisconsin, United States, 53201
- Physical Activity & Health Research Laboratory
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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:
- Male or female individuals living in the community.
- Aged between 50 and 85 years, at screening.
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
- Sufficient cognitive function, as demonstrated by responses to the mini-mental state examination(>23 score).
- Be able to read and write in English
- Sedentary behavior, demonstrated by no regular activity / exercise for previous 6 months and/or a Stage of Change 2 and 3
Exclusion Criteria:
- 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.
- 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.
- Significant uncontrolled metabolic disease, e.g. hemoglobin A1c levels greater than 8.0 and/or glucose levels greater than 300 mg/dL.
- Fracture of lower extremity within three months.
- Amputation other than toes.
- Current history of severe arthritis or orthopedic condition precluding physical activity.
- Participation in any regular structured exercise (resistance training, Tai Chi, high intensity walking, jogging, cycling, stair climbing, stepping, within the previous 6 months.
- 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 |
|---|---|
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No Intervention: Usual Care
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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.
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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.
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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
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Pedometer determined physical activity
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Keywords
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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