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

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.

Study Overview

• Status: Completed
• Conditions: Distorted; Balance; Lower Extremity Weakness Distal
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Falls ascertained in automated monthly telephone contact	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall-related injuries requiring hospitalization/emergency department care	Events ascertained in a monthly automated telephone interview	6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: exercise; safety; injury; Older adults; Falls
• Other Study ID Numbers: U48DP002657-RCT; U48DP002657 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified research data will be made available to qualified investigators