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N/A N=102 Randomized Double-blind Prevention

Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging

Accidental Falls

Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Hip Abductor Torque — 0.49; 0.49; 0.59; 0.0523 Nm/kg-m

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Physical Training Interventions (Other)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
University of Maryland, Baltimore
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Hip Abductor Torque
0.49; 0.49; 0.59; 0.0523; 0.52; 0.61
PRIMARY
Step Count
1.63; 1.55; 1.67; 1.78; 1.14; 1.24
SECONDARY
Falls
0.39; 0.27; 0.23; 0.88

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.

Eligibility Criteria

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 16)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01370174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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