NCT01370174: LIFT

Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging

Completed NA Results posted Last updated 5 October 2021

What this trial tests

NA trial testing Physical Training Interventions in Accidental Falls in 102 participants. Completed in 24 February 2017.

Timeline

25 January 2012

Primary endpoint
9 December 2016

24 February 2017

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	prevention
Enrollment	102
Start date	25 January 2012
Primary completion	9 December 2016
Estimated completion	24 February 2017
Sites	2 locations across United States

Drugs / interventions tested

• Physical Training Interventions

Conditions studied

• Accidental Falls — all drugs for Accidental Falls →

Sponsor

University of Maryland, Baltimore

Who can join

65 and older, any sex, with Accidental Falls. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hip Abductor Torque Primary · At baseline and post-test at 3 months

Hip abductor torque at baseline and 3 months

Baseline (Hip Strength Torque/Power)

Group	Value	95% CI
Induced Step Training (IST)	0.49	± 0.04
Hip Strength Training (HST)	0.49	± 0.02
Combined Induced Step and Hip Strength Training	0.59	± 0.04
Standard Flexibility and Relaxation (SFR)	0.0523	± 0.03

Post-Test (Hip Strength Torque/Power)

Group	Value	95% CI
Induced Step Training (IST)	0.52	± 0.03
Hip Strength Training (HST)	0.61	± 0.03
Combined Induced Step and Hip Strength Training	0.62	± 0.05
Standard Flexibility and Relaxation (SFR)	0.55	± 0.03

Step Count Primary · At baseline and post-test at 3 months

The number of balance recovery steps at balance tolerance threshold at baseline and 3 months

Baseline Balance Recovery Steps

Group	Value	95% CI
Induced Step Training (IST)	1.63	± .057
Hip Strength Training (HST)	1.55	± .042
Combined Induced Step and Hip Strength Training	1.67	± .073
Standard Flexibility and Relaxation (SFR)	1.78	± .065

Post-Test Balance Recovery Steps

Group	Value	95% CI
Induced Step Training (IST)	1.14	± .080
Hip Strength Training (HST)	1.24	± .12
Combined Induced Step and Hip Strength Training	0.97	± .067
Standard Flexibility and Relaxation (SFR)	1.24	± .099

Falls Secondary · Individual subject at 12 months post training

Analysis of fall history between falls in the year prior to enrollment and 12 months after training finished.

Group	Value	95% CI
Induced Step Training (IST)	0.39	0.19 – 00.82
Hip Strength Training (HST)	0.27	0.10 – 0.71
Combined Induced Step and Hip Strength Training	0.23	0.07 – 0.72
Standard Flexibility and Relaxation (SFR)	0.88	0.53 – 1.16

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Induced Step Training (IST)

Serious: 0/25 (0%)

Deaths: —

Hip Strength Training (HST)

Serious: 0/26 (0%)

Deaths: —

Combined Induced Step and Hip Strength Training

Serious: 0/25 (0%)

Deaths: —

Standard Flexibility and Relaxation (SFR)

Serious: 0/26 (0%)

Deaths: —

Other adverse events (12 terms — click to expand)

Reaction	System	Induced Step Training (IST)	Hip Strength Training (HST)	Combined Induced Step and …	Standard Flexibility and R…
Low Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
R Leg Bruise	Skin and subcutaneous tissue disorders	—	—	—	—
Fall	Musculoskeletal and connective tissue disorders	—	—	—	—
Quad and Hip Abductor Soreness	Musculoskeletal and connective tissue disorders	—	—	—	—
R Knee Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
R Arm Abrasion	Skin and subcutaneous tissue disorders	—	—	—	—
Hip Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Redness/Swelling of Scrotum	Reproductive system and breast disorders	—	—	—	—
Belching/Burping	Gastrointestinal disorders	—	—	—	—
Muscle Soreness	Musculoskeletal and connective tissue disorders	—	—	—	—
Hip Flexor Cramping	Musculoskeletal and connective tissue disorders	—	—	—	—
Abdominal Cramping	Musculoskeletal and connective tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT01370174 adverse events section.

Sponsor's own 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 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Lateral Perturbation-Induced Step Training and Hip Muscle Strengthening Exercise on Balance and Falls in Community-Dwelling Older Adults: A Blinded Randomized Controlled Trial.
   Rogers MW, Creath RA, Gray V, Abarro J, et al · · 2021 · cited 31× · PMID 33491052 · DOI 10.1093/gerona/glab017