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Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program

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ClinicalTrials.gov Identifier: NCT01552551
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : December 30, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.

Condition or disease Intervention/treatment
Lower Extremity Weakness Distal Distorted; Balance Behavioral: Assessment and education Behavioral: Healthy Steps with Falls Case Management Behavioral: Healthy Steps in Motion

Detailed Description:

This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.

This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
Study Start Date : May 2012
Primary Completion Date : January 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Healthy Steps
Healthy Steps program as currently implemented by the PA Department of Aging
Behavioral: Assessment and education
PA Healthy Steps program
Experimental: Healthy Steps with Falls Case Management
Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment
Behavioral: Healthy Steps with Falls Case Management
Counseling to ensure that participants receive a physician assessment and home safety check
Experimental: Healthy Steps in Motion
Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise.
Behavioral: Healthy Steps in Motion
Group exercise program

Outcome Measures

Primary Outcome Measures :
  1. Falls [ Time Frame: 6 months ]
    Falls ascertained in automated monthly telephone contact

Secondary Outcome Measures :
  1. Fall-related injuries requiring hospitalization/emergency department care [ Time Frame: 6 months ]
    Events ascertained in a monthly automated telephone interview

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Able to provide informed consent
  2. Willing to be randomized
  3. Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
  4. Age 50+

Exclusion Criteria:

  1. Hospice enrollee or life-threatening illness
  2. Active cancer treatment
  3. Neurologic disease linked to falls risk, such as Parkinson's
  4. Unable to ambulate indoors
  5. High likelihood of moving in next 6 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552551

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Centers for Disease Control and Prevention
Principal Investigator: Steven M Albert, PhD University of Pittsburgh
More Information

Responsible Party: Steven M. Albert, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01552551     History of Changes
Other Study ID Numbers: U48DP002657-RCT
U48DP002657 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified research data will be made available to qualified investigators

Keywords provided by Steven M. Albert, University of Pittsburgh:
Older adults