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

Distorted; Balance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552551
• Other study ID #: U48DP002657-RCT
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: December 29, 2015
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Distorted; Balance
• Lower Extremity Weakness Distal

Intervention

Behavioral:
• Assessment and education
PA Healthy Steps program
• Healthy Steps with Falls Case Management
Counseling to ensure that participants receive a physician assessment and home safety check
• Healthy Steps in Motion
Group exercise program

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	Falls ascertained in automated monthly telephone contact	6 months	No
Secondary	Fall-related injuries requiring hospitalization/emergency department care	Events ascertained in a monthly automated telephone interview	6 months	No