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

University of Pittsburgh

Status: Completed

Conditions: Distorted; Balance; Lower Extremity Weakness Distal

Treatments: Behavioral: Assessment and education; Behavioral: Healthy Steps in Motion; Behavioral: Healthy Steps with Falls Case Management

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01552551

U48DP002657-RCT

U48DP002657 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 189 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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189 participants in 3 patient groups

Healthy Steps

Active Comparator group

Description:

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

Treatment:

Behavioral: Assessment and education

Healthy Steps with Falls Case Management

Experimental group

Description:

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

Treatment:

Behavioral: Healthy Steps with Falls Case Management

Healthy Steps in Motion

Experimental group

Description:

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

Treatment:

Behavioral: Healthy Steps in Motion