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Trial record 2 of 3 for:    vicki gray

Hip Muscle Power, Lateral Balance Function, and Falls in Aging (HIPS)

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ClinicalTrials.gov Identifier: NCT03731572
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
VA Maryland Health Care System
Information provided by (Responsible Party):
Vicki Gray, University of Maryland, Baltimore

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 develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. 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. Age-related declines in lateral balance function result from neuromuscular and biomechanical limitations in hip abductor-adductor muscle power generation. This study will test whether these impairments can be improved with high-velocity hip muscle resistance power training that will be more effective than conventional resistance strength training.

Condition or disease Intervention/treatment Phase
Accidental Falls Other: Power Training Other: Strength Training Not Applicable

Detailed Description:
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 develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. 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. The investigators propose that age-related declines in lateral balance function through impaired weight transfer and protective stepping linked with falls, result from neuromuscular and biomechanical limitations in hip abductor-adductor (AB-AD) muscle power generation. Moreover, the investigators hypothesize that these balance and neuromotor impairments can be improved with high-velocity muscle resistance power training that will be more effective than conventional muscle resistance strength training. The specific aims are, Aim 1: To conduct a single blind, randomized, and controlled trial comparing the effects of 12 weeks of hip AB-AD muscle power training against strength training, and the rate of retention after 3 months of no training in community living older adults by determining a) the changes in neuromotor performance (kinetics, kinematics, muscle activation patterns) of pre-step weight transfer during waist-pull induced side stepping, and rapid voluntary reaction time (RT) sidestepping; and by b) the changes in isolated hip AB-AD muscle neuromotor performance. Weight shifting and stepping ability will be tested with different initial induced stepping limb load conditions, and by varying voluntary stepping limb selection certainty with simple and choice RT tasks; Aim 2: To compare the effectiveness of hip AB-AD muscle power and strength training in reducing the rate of prospective falls over a one-year monitoring period post-training. Secondary analyses will assess the number of in-task falls, and the effect of muscle power versus strength training on changes in functional balance and mobility. Overall, the studies are expected to establish support for the superiority of velocity dependent power training over strength training on enhancing muscle performance, protective balance control and functional mobility outcomes, and for the prevention of falls among older adults.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The investigators will compare changes in protective stepping, hip abduction and adduction muscle power and neuromuscular activation, balance and mobility function, and number of prospective falls between power and strength training groups.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: All testing for Aims 1a and 1b will be conducted by individuals who are masked to subject intervention group assignment at baseline-testing, post-intervention testing, and retention-testing
Primary Purpose: Prevention
Official Title: Hip Muscle Power, Lateral Balance Function, and Falls in Aging
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Power Training
Hip abductor-adductor resistance exercises at 75% maximum strength and maximum execution speed, 3, 1-hour training sessions per week for 12 weeks.
Other: Power Training
Hip abductor-adductor resistance exercises at maximum execution speed

Active Comparator: Strength Training
Hip muscle abductor-adductor resistance exercises at maximum strength at reduced execution speed (2s concentric/3s eccentric), 3, 1-hour training sessions per week for 12 weeks.
Other: Strength Training
Hip abductor-adductor resistance exercises at reduced execution speed




Primary Outcome Measures :
  1. Incidence of single lateral steps [ Time Frame: At 3 months ]
    Change in number of single steps between pre and post tests


Secondary Outcome Measures :
  1. Hip muscle power [ Time Frame: At 3 months ]
    Change in maximum hip power between pre and post tests

  2. Number of Falls [ Time Frame: 12 months ]
    Total number of falls reported at 1 year follow up.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 65 years of age or older
  2. Functionally independent
  3. Living in the community
  4. Generally healthy

Exclusion Criteria:

  1. Cognitive impairment (Mini Mental Score Exam less than 24)
  2. Sedative use
  3. Non-ambulatory
  4. Any clinically significant musculoskeletal impairment
  5. Any clinically significant neurological impairment
  6. Any clinically significant cardiopulmonary impairment
  7. Any clinically significant metabolic impairment
  8. Any general medical problem that will interfere with testing or training
  9. Diabetes, renal, or liver disease by identified by routine chemistry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731572


Contacts
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Contact: Vicki L Gray, PhD 410-706-3778 vicki.gray@som.umaryland.edu
Contact: Janice Abarro, BS 410-706-0856 jabarro@som.umaryland.edu

Locations
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United States, Maryland
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: Vicki Gray, PT, PhD    410-706-3778    vgray@som.umaryland.edu   
Principal Investigator: Mark W. Rogers, PT, PhD         
Sponsors and Collaborators
University of Maryland, Baltimore
VA Maryland Health Care System
Investigators
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Principal Investigator: Vicki L Gray, PhD University of Maryland, Baltimore
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Responsible Party: Vicki Gray, Assistant Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03731572    
Other Study ID Numbers: HP-00082488
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vicki Gray, University of Maryland, Baltimore:
Falls
Balance
Protective Stepping
Lateral Balance
Elderly
Power training