Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Maryland
Sponsor:
Collaborators:
Northwestern University
VA Maryland Health Care System
Information provided by (Responsible Party):
Mark W. Rogers, University of Maryland
ClinicalTrials.gov Identifier:
NCT01370174
First received: June 8, 2011
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Accidental Falls
Other: Physical Training Interventions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Training groups will demonstrate greater and prolonged improvement in balance function and hip strength [ Time Frame: Individual subject at baseline, immediately after training and 3 months after last training session; all data at end of project ] [ Designated as safety issue: Yes ]
    Improvement is measured by: 1) number of balance recovery steps, 2) first protective step characteristics, and 3) hip stregnth torque and power, performed before and after training

  • Combination training with induced stepping and hip strengthening will show greatest improvement for balance function and hip muscle strength [ Time Frame: Individual subject at baseline, immediately after training and 3 months after last training session; all data at end of project ] [ Designated as safety issue: Yes ]
    Greater improvement measured by: 1) number of balance recovery steps, 2) first protective step characteristics and 3) hip strength torque and power will be demonstrated in the combination induced step and strength training group compared to other training groups


Secondary Outcome Measures:
  • 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, immediately after training, 3 months after last training session and 12 months after last training session; all data at end of project ] [ Designated as safety issue: Yes ]
    Analysis of fall history with protective stepping performance, balance function and hip strength will differ between older adults who fall and do not fall


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 <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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370174

Contacts
Contact: Mark W Rogers, PT, PhD 410-706-0841 mrogers@som.umaryland.edu
Contact: Michelle Prettyman, PT 410-706-7165 mprettyman@som.umaryland.edu

Locations
United States, Maryland
PTRS Research Lab Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark W Rogers, PT, PhD    410-706-0841    mrogers@som.umaryland.edu   
Contact: Michelle Prettyman, PT    410-706-7165    mprettyman@som.umaryland.edu   
Principal Investigator: Mark W. Rogers, PT, PhD         
VA Maryland Health Care System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark W. Rogers, PT, PhD    410-706-0841    mrogers@som.umaryland.edu   
Contact: Michelle Prettyman, PT    410-706-7165    mprettyman@som.umaryland.edu   
Principal Investigator: Mark W. Rogers, PT, PhD         
Sponsors and Collaborators
University of Maryland
Northwestern University
VA Maryland Health Care System
Investigators
Principal Investigator: Mark W Rogers, PT, PhD University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Mark W. Rogers, Professor and Vice Chair of Research, University of Maryland
ClinicalTrials.gov Identifier: NCT01370174     History of Changes
Other Study ID Numbers: HP-00045644
Study First Received: June 8, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Falls
Balance
Protective Stepping
Lateral Balance
Elderly

ClinicalTrials.gov processed this record on July 24, 2014