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

Not Applicable

Completed

• Conditions: Distorted; Balance; Lower Extremity Weakness Distal
• Interventions: Behavioral: Healthy Steps in Motion; Behavioral: Assessment and education; Behavioral: Healthy Steps with Falls Case Management

• Registration Number: NCT01552551
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Study Start: 2012-05
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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+

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Steps in Motion	Healthy Steps in Motion	Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise.
Healthy Steps	Assessment and education	Healthy Steps program as currently implemented by the PA Department of Aging
Healthy Steps with Falls Case Management	Healthy Steps with Falls Case Management	Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment

Primary Outcome Measures

Name	Time	Method
Falls	6 months	Falls ascertained in automated monthly telephone contact

Secondary Outcome Measures

Name	Time	Method
Fall-related injuries requiring hospitalization/emergency department care	6 months	Events ascertained in a monthly automated telephone interview

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States