Overview

This trial is active, not recruiting.

Condition accidental falls
Treatment physical training interventions
Phase phase 2
Sponsor University of Maryland
Collaborator Northwestern University
Start date July 2011
End date May 2017
Trial size 100 participants
Trial identifier NCT01370174, HP-00045644

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
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)
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
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)
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
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)
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
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.

Primary Outcomes

Measure
Training groups will demonstrate greater and prolonged improvement in balance function and hip strength
time frame: At 3 months
Combination training with induced stepping and hip strengthening will show greatest improvement for balance function and hip muscle strength
time frame: At 3 months.

Secondary Outcomes

Measure
Older adults who fall will be discriminated from non-fallers based on training improvements in balance function and hip strength
time frame: Individual subject at baseline, at 3 months.

Eligibility Criteria

Male or female participants at least 65 years old.

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)

Additional Information

Official title Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging
Principal investigator Mark W Rogers, PT, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Maryland.