NCT03731572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6.3 years

First QC Date

October 1, 2018

Last Update Submit

January 22, 2026

Conditions

Keywords

FallsBalanceProtective SteppingLateral BalanceElderlyPower training

Outcome Measures

Primary Outcomes (1)

  • Incidence of single lateral steps

    Change in number of single steps between pre and post tests

    At 3 months

Secondary Outcomes (2)

  • Hip muscle power

    At 3 months

  • Number of Falls

    12 months

Study Arms (2)

Power Training

EXPERIMENTAL

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

Strength Training

ACTIVE COMPARATOR

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

Interventions

Hip abductor-adductor resistance exercises at maximum execution speed

Power Training

Hip abductor-adductor resistance exercises at reduced execution speed

Strength Training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • Functionally independent
  • Living in the community
  • Generally healthy

You may not qualify if:

  • Cognitive impairment (Mini Mental Score Exam less than 24)
  • Sedative use
  • Non-ambulatory
  • Any clinically significant musculoskeletal impairment
  • Any clinically significant neurological impairment
  • Any clinically significant cardiopulmonary impairment
  • Any clinically significant metabolic impairment
  • Any general medical problem that will interfere with testing or training
  • Diabetes, renal, or liver disease by identified by routine chemistry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vicki L Gray, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 1, 2018

First Posted

November 6, 2018

Study Start

September 16, 2019

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations