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

NCT01158638 | Unknown Phase 2 DMC

• 2 other identifiers: StepCountK01AG025962
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Activity; Elderly

Keywords

Physical Activity Enhancement

Outcome Measures

Primary Outcomes (1)

• Objectively assessed steps per day

  Pedometer determined physical activity

  12 weeks

Study Arms (3)

Usual Care

NO INTERVENTION

Usual Care

10,000 Steps Group

ACTIVE COMPARATOR

Each participant randomized to this study arm will receive a pedometer and a generic recommendation to accumulate 10,000 Steps per Day.

Behavioral: Web Mediated Step Intervention

Web Mediated Step Group

EXPERIMENTAL

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

Behavioral: Web Mediated Step Intervention

Interventions

Web Mediated Step Intervention BEHAVIORAL

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.

10,000 Steps Group; Web Mediated Step Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Physical Activity & Health Research Laboratory

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Scott J Strath, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

US (1)