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

Physical Activity Clinical Trial

— StepCount  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01158638
• Other study ID #: StepCount
• Secondary ID: K01AG025962
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 7, 2010
• Last updated: May 27, 2015
• Start date: August 2009
• Est. completion date: July 2016

Study information

• Verified date: May 2015
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Individually tailored, mediated pedometer feedback will provide an effective method to promote physical activity adoption in the elderly

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elderly
• Physical Activity

Intervention

Behavioral:
• Web Mediated Step Intervention
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.

Locations

Country	Name	City	State
United States	Physical Activity & Health Research Laboratory	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objectively assessed steps per day	Pedometer determined physical activity	12 weeks	No