Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging (LIFT)

Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to establish the efficacy of a scientifically grounded and mechanism-based therapeutic intervention for improving balance function and preventing falls in older people. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. We propose that age-related declines in lateral balance function through impaired protective stepping that precipitates falls, result from neuromechanical (NM) limitations in hip abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that these functional and NM impairments are reversible with combined high intensity induced step training (IST) and muscle strengthening.

Study Overview

• Status: Completed
• Conditions: Accidental Falls
• Intervention / Treatment: Other: Physical Training Interventions

Detailed Description

Falls and their consequences are among the major problems in the medical care of older individuals. Some 30 percent of community dwelling people aged 65 years and older, and over 50 percent of those living in institutions fall each year. Among older adults, complications of falls are the leading cause of deaths due to injury and are the most common cause of nonfatal injuries and hospitalization for trauma. The total lifetime healthcare cost of fall-related injuries for the elderly have been projected to reach $85 billion by the year 2020. Even in the absence of injury due to falling, the tendency to lose balance among the elderly commonly results in an overall reduction in the level of physical activity, and to a decreased ability to satisfactorily function in social roles.

Despite the contributions of multiple risk factors to age-related falls (e.g., environmental hazards, orthostatic hypotension, disorientation, sedation), it is well recognized that those who fall present greater impairments in neuromechanical (NM) factors than do older non-fallers. Aging changes in balance and gait associated with NM impairments have also been consistently found to be among the most important risk factors for falls. What is presently unresolved, however, is which among the age-associated NM impairments, altered balance and mobility functions are best associated with falls and responsive to interventions (training).

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • VA Maryland Health Care System
    • Baltimore, Maryland, United States, 21201
      • PTRS Research Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 65 years of age or older
• Body Mass Index in range of 18.5 to 30

Exclusion Criteria:

• Timed -Up-and-Go faster than 12 seconds (very low fall risk)
• Persons advised by their doctor not to exercise
• Evidence of any medical condition as determined by physician or results of blood test that would lead to increased risk of accident, injury or illness due to any aspect of proposed tests and interventions, including resistance training
• Persons with history of brain, nerve or muscle disorder including Parkinson's disease, stroke, peripheral neuropathy or myopathy
• Persons with reported hip or knee joint replacement in past 6 months
• Persons with significant foot deformities or amputation as determined by a qualified medical professional
• Persons with sedative medications including hypnotics, anxiolytic, opioids, neuroleptics, or sedating antidepressants
• Persons using medications that pose a significant bleeding risks as determined by a qualified medical professional
• Any significant functional limitation as determined by a score of zero on any of the six daily tasks of the Instrumental Activities of Daily Living Scale (IADL) that enable independent living in the community. The six functional items used are: A. Telephone, B. Shopping, C. Food Preparation, D. Housekeeping, E. Laundry, and F. Transportation
• Non-ambulatory (unable to walk)
• Persons using a gait device at all times in home environment
• Cognitive impairment defined as Mini-Mental State Exam score <24
• Persons with uncorrected vision limiting visual function or eye surgery in ast 6 months
• Persons with uncorrected hearing impairment limiting daily activities or communication as determined by a qualified medical professional
• Persons with major depression (Centers for Epidemiological Studies Depression Survey score >16)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Induced Step Training (IST); The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.	Other: Physical Training Interventions; Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
ACTIVE_COMPARATOR: Hip Strength Training (HST); The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.	Other: Physical Training Interventions; Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
ACTIVE_COMPARATOR: Combined Induced Step and Hip Strength Training; This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).	Other: Physical Training Interventions; Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
PLACEBO_COMPARATOR: Standard Flexibility and Relaxation (SFR); The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.	Other: Physical Training Interventions; Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Abductor Torque	Hip abductor torque at baseline and 3 months	At baseline and post-test at 3 months
Step Count	The number of balance recovery steps at balance tolerance threshold at baseline and 3 months	At baseline and post-test at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Analysis of fall history between falls in the year prior to enrollment and 12 months after training finished.	Individual subject at 12 months post training

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Northwestern University; VA Maryland Health Care System
• Investigators: Principal Investigator: Mark W Rogers, PT, PhD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2012
• Primary Completion (ACTUAL): December 9, 2016
• Study Completion (ACTUAL): February 24, 2017

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (ESTIMATE): June 9, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Balance; Falls; Protective Stepping; Lateral Balance
• Other Study ID Numbers: HP-00045644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO