N/A N=27 Randomized Single-blind Prevention

Improving Balance and Mobility

Postural Balance · Accidental Falls · Mobility Limitation

Bottom Line

View on ClinicalTrials.gov: NCT02374463 ↗

Enrolled (actual)

Serious AEs

7.4%

Results posted

Mar 2020

Primary outcome: Primary: Balance and Lateral Mobility Assessed by the Four Square Step Test — -1.8; -0.6 seconds — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MMBI (Behavioral); Tai Chi (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Balance and Lateral Mobility Assessed by the Four Square Step Test	-1.8; -0.6	<0.05 sig
SECONDARY Functional Gait Analysis	7.28; -0.5	=0.08
SECONDARY Change in Strength R Knee Biodex	21.8; -16.2	=0.6
SECONDARY Number of Subjects Who Reported Falls	3; 3	0.84
SECONDARY Change in Strength R Hip Using Biodex	10.4; -10.1	=0.3

Summary

Falls are dangerous leading to injuries and even death. The VA has made fall prevention a priority, but effective programs only reduce falls by 30%. Tai Chi, a standing exercise program, has been effective at improving balance but may not prevent falls. Most falls occur during walking when an individual experiences a slip or a trip. Programs that focus on walking, stepping, and recovery from a slip may be more effective at fall reduction. This study will compare Tai Chi to a novel multimodal balance intervention (MMBI). MMBI focuses on standing balance, walking, stepping, strength training, and recovery from a slip. The Investigators believe that the MMBI program will be more effective than Tai Chi at improving balance and preventing falls in older Veterans and the Investigators will use the results of this study to develop a larger study on fall prevention in older Veterans.

Eligibility Criteria

Inclusion Criteria

65 years of age and older
Mobility and balance limitations as demonstrated by a self-reported fall within the past year or requiring greater than 8 seconds to complete the 4-square step test

Exclusion Criteria

Cardiovascular Risks: Poorly controlled hypertension (>160/100); Class III or IV congestive heart failure (CHF); or patient report of: symptomatic angina at rest or during exercise, syncope without known resolution of cause, or a significant coronary event (such as a MI) in the past six months
Chronic obstructive pulmonary disease (COPD) requiring home oxygen
Contraindications to resistance training, including a self-reported history of intracranial or retinal bleeding in the last year or Diabetes with active proliferative retinopathy
Patient report of significant spinal stenosis that would limit participation in the exercise intervention -Dementia (on medical record review or mini-mental status exam score <24).
Non-ambulatory mobility status or a transtibial or transfemoral amputation
Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02374463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.