Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Completed NCT03963570 - The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People N/A
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Not yet recruiting NCT04419753 - The Role of Attention Focus Walking Training in Older Adults. N/A
Completed NCT02916849 - A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People N/A
Completed NCT02836587 - The Influence of Balance Training on Postural Control in Elderly N/A
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT01896466 - Enhanced Gait and Balance Training N/A
Completed NCT02570178 - Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii) N/A
Completed NCT00636675 - CONNECT for Quality: A Study to Reduce Falls in Nursing Homes N/A
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT00226486 - Examination and Treatment of Elderly After a Fall N/A
Active, not recruiting NCT00222287 - The Effect of Feldenkrais Lessons on Walking and Balance Phase 1
Recruiting NCT05625828 - Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors N/A
Recruiting NCT05377801 - Chinese Version of LIVE-LiFE for Older Adults With Previous Falls N/A
Completed NCT01618786 - Flooring for Injury Prevention Trial N/A
Completed NCT02835989 - Community Paramedicine at Home N/A
Recruiting NCT02926105 - Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults Phase 3
Completed NCT02569138 - Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear N/A
Terminated NCT01422252 - Evaluation of a Fall Detection Device in Isolated Elderly N/A