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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03731572
Other study ID # HP-00082488
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 16, 2019
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source University of Maryland, Baltimore
Contact Vicki L Gray, PhD
Phone 410-706-3778
Email vicki.gray@som.umaryland.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Power Training
Hip abductor-adductor resistance exercises at maximum execution speed
Strength Training
Hip abductor-adductor resistance exercises at reduced execution speed

Locations

Country Name City State
United States VA Maryland Health Care System Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, Baltimore VA Maryland Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of single lateral steps Change in number of single steps between pre and post tests At 3 months
Secondary Hip muscle power Change in maximum hip power between pre and post tests At 3 months
Secondary Number of Falls Total number of falls reported at 1 year follow up. 12 months
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