Fall Recovery Training for Older Adults in Continuous Care Facilities

• ClinicalTrials.gov Identifier: NCT02173015
• Recruitment Status: Completed
• First Posted: June 24, 2014
• Last Update Posted: April 4, 2017
• Sponsor: Mayo Clinic
• Collaborator: University of Illinois at Chicago
• Information provided by (Responsible Party): Kenton R. Kaufman, Ph.D., Mayo Clinic

Study Description

Brief Summary:

The purpose of this study is to evaluate the effect that a new fall prevention training program has on the fall incidence of long-term care facility residents at high-risk of falling.

Condition or disease	Intervention/treatment	Phase
Accidental Falls	Other: Compensatory step training	Not Applicable

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Compensatory Step Training for Reducing the Fall Incidence of Older Adults Residing in Continuous Care Facilities
• Study Start Date: April 2014
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Low Fall Risk; Individuals who have a functional reach greater than 8" and a unipedal stance time greater than 5 s.
No Intervention: High Fall Risk, No Training; Individuals who have a functional reach of 8" or less OR a unipedal stance time of 5 s or less, but do not qualify for compensatory step training due to health concerns.
Experimental: High Fall Risk, Training; Individuals who have a functional reach of 8" or less OR a unipedal stance time of 5 s or less, and qualify for compensatory step training.	Other: Compensatory step training; The training consists of a progression of anterior or posterior treadmill belt movements applied as the subject is standing or walking. This training specifically focuses on aspects important to trip and slip recovery. Subjects will participate in up to 6 sessions in 7 to 30 days. The training intensity (magnitude of disturbance delivered) is progressive and dependent on subject performance. Subjects will be instructed to respond with single or multiple steps in order to prevent a fall. All subjects will be outfitted with a safety harness to prevent injury. Up to 72 disturbances will be delivered each session.

Outcome Measures

Primary Outcome Measures :

1. Fall Incidence [ Time Frame: up to 6 months ]
   The fall incidence (fallers / total group size) of low-risk residents, high-risk residents who do not complete training, and high-risk residents who complete training.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Subjects must be 50 years or older, living in continuous-care retirement facilities.

Exclusion Criteria:

1. For participation in study:

   • Three or more errors on the Six-Item Screener for Cognitive Impairment
   • Individuals who cannot provide consent for themselves

2. For participation in compensatory step training:

   • Physician or nurse practitioner approval to participate in the study with the guidelines that subjects should not participate if any of the following is applicable:
   • Unable to walk one block without stopping or using a walking aid (self-reported)
   • Acute illness at the time of functional assessment or training
   • Body mass greater than 114 kg
   • Body size too large for wearing a safety harness
   • Lower extremity joint replacement within a year prior to participation
   • Femoral neck or total hip bone mineral density t-score less than -2.5
   • Based on a dual-energy X-ray absorptiometry (DXA) scan in the Mayo Clinic Charlton Clinical Research Unit (CRU), with no medication changes that may affect bone mineral density at the hip (e.g. starting prednisone). During the visit to the CRU, the subject's height and weight will be measured.
   • If the subject has had a hip DXA scan within 6 months of participation, the exclusion criterion will be based on the previous scan.
   • If the subject has had bilateral hip replacement, then the subject will not qualify for compensatory step training.
   • Dementia
   • Parkinson's disease
   • A history of stroke
   • A history of back surgery
   • Bulging vertebral discs
   • Spine, hip, or lower extremity fracture within a year prior to participation
   • Open lesions on the lower extremity
   • In case of lower extremity amputation, stump volume fluctuations within a year of training
   • Use of a pacemaker
   • Use of an ostomy pouch
   • Pregnancy
   • Doctor recommendation to avoid moderate physical activity or exercise
   • Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training, at the discretion of the clinician or study staff.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

University of Illinois at Chicago

Investigators

• Principal Investigator: Kenton R Kaufman, PhD; Mayo Clinic

More Information

• Responsible Party: Kenton R. Kaufman, Ph.D., W Hall Wendel Jr Musculoskeletal Research Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02173015 History of Changes
• Other Study ID Numbers: 13-000605; UL1TR000135 ( U.S. NIH Grant/Contract )
• First Posted: June 24, 2014
• Last Update Posted: April 4, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kenton R. Kaufman, Ph.D., Mayo Clinic:

accidental falls; older adults; long-term care; nursing home; postural balance