Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging

NCT01370174 | Completed Results DMC

• 1 other identifier: HP-00045644
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Accidental Falls

Keywords

Falls; Balance; Protective Stepping; Lateral Balance; Elderly

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Falls

  Individual subject at 12 months post training

Study Arms (4)

Induced Step Training (IST)

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.

Other: Physical Training Interventions

Hip Strength Training (HST)

ACTIVE COMPARATOR

The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.

Other: Physical Training Interventions

Combined Induced Step and Hip Strength Training

ACTIVE COMPARATOR

This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).

Other: Physical Training Interventions

Standard Flexibility and Relaxation (SFR)

PLACEBO COMPARATOR

The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.

Other: Physical Training Interventions

Interventions

Physical Training Interventions OTHER

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.

Combined Induced Step and Hip Strength Training; Hip Strength Training (HST); Induced Step Training (IST); Standard Flexibility and Relaxation (SFR)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Northwestern University: collaborator
• VA Maryland Health Care System: collaborator

Study Sites (2)

PTRS Research Lab

Baltimore, Maryland, 21201, United States

Location

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

Results Point of Contact

• Title: Dr. Vicki Gray Principal Investigator
• Organization: University of Maryland

vicki.gray@som.umaryland.edu

4107063778

Study Officials

• Mark W Rogers, PT, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: January 25, 2012
• Primary Completion: December 9, 2016
• Study Completion: February 24, 2017
• Last Updated: October 5, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)