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

NCT ID: NCT01552551

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Lower Extremity Weakness Distal Distorted; Balance

Keywords

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Falls exercise safety injury Older adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Healthy Steps

Healthy Steps program as currently implemented by the PA Department of Aging

Group Type ACTIVE_COMPARATOR

Assessment and education

Intervention Type BEHAVIORAL

PA Healthy Steps program

Healthy Steps with Falls Case Management

Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment

Group Type EXPERIMENTAL

Healthy Steps with Falls Case Management

Intervention Type BEHAVIORAL

Counseling to ensure that participants receive a physician assessment and home safety check

Healthy Steps in Motion

Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise.

Group Type EXPERIMENTAL

Healthy Steps in Motion

Intervention Type BEHAVIORAL

Group exercise program

Interventions

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Assessment and education

PA Healthy Steps program

Intervention Type BEHAVIORAL

Healthy Steps with Falls Case Management

Counseling to ensure that participants receive a physician assessment and home safety check

Intervention Type BEHAVIORAL

Healthy Steps in Motion

Group exercise program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Steven M. Albert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven M Albert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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U48DP002657

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U48DP002657-RCT

Identifier Type: -

Identifier Source: org_study_id