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NCT07094659
Aging and Task-specific Training to Reduce Falls
Conditions: Fall Prevention
Sex: All
Ages: 60 Years – 90 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 315
Sponsor: University of Illinois at Chicago
Location: University of Illinois at Chicago Chicago Illinois
Summary
The goal of this clinical trial is to examine the effects of a novel task-specific balance training for reducing environmental falls in community ambulatory older adults who are at-risk of falling. The main questions it aims to answer are:
* Does task-specific balance training improve the ability to prevent falling when unexpected perturbations such as slips and trips occur, and/or improve balance control during self-initiated movements?
* Does task-specific balance training reduce real-life falls for 18 months after training?
Researchers will compare task-specific balance training with conventional balance training and treadmill perturbation-based training to examine how this novel intervention compares to established interventions for improving balance.
Participants who participate in the study will be asked to do the following:
* Complete a pre-training assessment of their balance control, and then be randomized to one of three training groups: 1) task-specific balance training, 2) treadmill perturbation-based training, and 3) conventional balance training
* Complete their assigned training protocol for 8 weeks (2x per week for a total of 16 sessions)
* Complete 2 post-training assessments of their balance control, the first being completed immediately after the training is completed, and the second being completed 18 months after the training is completed
* Wear a physical activity monitor for 18 months after completing the intervention to monitor their real life falls.
Eligibility Criteria
Inclusion Criteria:
* 60 to 90 years of age to include community dwelling older adults
* Understand English to ensure ability to safely complete study protocols
* Able to walk independently for 1 block and 10 meters without an assistive device to ensure ability to complete exercises and reactive balance assessments
* 'At-risk' adults: Participants who report experience of at least 1 fall in the past 12 months or participants who are categorized as at high fall- risk using our fall risk prediction model which can predict the risk of both slip and trip related falls.
Exclusion Criteria:
* Major surgery less than 6 months ago to avoid complications due to training
* Hospitalization less than 3 months ago to avoid complications due to training
* Taking any sedative drugs to avoid interference with training
* Acute or uncontrolled neurological or cardiopulmonary or musculoskeletal or cancer diagnosis to avoid complications due to training
* Have intact visual and auditory ability with or without corrective aids to avoid confounding effects on balance
* Severe osteoporosis measured by a score of less than negative two point five on heel bone density scan to avoid complications due to training
* Loss of sensation on monofilament test to avoid confounding effects on outcome assessments
* Cognitive impairment indicated by a score of less than 25 out of 30 on the mini mental state exam to ensure ability to follow instructions for safety
* Shortness of breath or uncontrolled pain higher than a three out of ten or inability to achieve age specified minimal distance on the 6 minute walk test for endurance to avoid complications due to training
Source: ClinicalTrials.gov (NCT07094659). StuddyBuddy aggregates publicly available trial information.