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Completed

NCT Number: NCT01552551

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.

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Key information

Conditions

Lower Extremity Weakness Distal Behavior Distorted; Balance Motor Activity Wounds and Injuries

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide informed consent
  • Willing to be randomized
  • Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
  • Age 50+

Exclusion criteria

  • Hospice enrollee or life-threatening illness
  • Active cancer treatment
  • Neurologic disease linked to falls risk, such as Parkinson's
  • Unable to ambulate indoors
  • High likelihood of moving in next 6 months

Treatment and study plan

Assessment and education

Behavioral

PA Healthy Steps program

Healthy Steps with Falls Case Management

Behavioral

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

Healthy Steps in Motion

Behavioral

Group exercise program

Primary outcomes

  1. Falls

    Time frame: 6 months

    Falls ascertained in automated monthly telephone contact

Secondary outcomes

  1. Fall-related injuries requiring hospitalization/emergency department care

    Time frame: 6 months

    Events ascertained in a monthly automated telephone interview

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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