Aging and Task-specific Training to Reduce Falls

Official title

Aging and Task-Specific Training to Reduce Falls

Overview

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.

Detailed description

The proposed study employs a randomized, controlled design to assess the immediate and long-term effects of task-specific balance training for reducing environmental falls in at-risk community-ambulatory older adults. \>33% of older adults fall at least once each year, leading to serious injuries (e.g., hip fractures), comorbidities (e.g., Alzheimer's Disease and related dementias), and higher chances of falling again. Most falls occur due to environmental disturbances which cause a loss of balance while walking (i.e., slips, trips). Our lab has established that overground perturbation training (repeated exposure to unpredicted perturbations) improves balance control in both predictable (i.e., volitional/anticipatory) and unpredictable (i.e., reactive) environments, and reduces real-life falls among older adults. However, overground perturbation training is not suitable for routine clinical application due to its complex design, space, and technology requirements. An alternative method for delivering perturbation training is via commercial treadmill systems, which enhance fall-resisting skills and are more feasible for community-translation. However, treadmill perturbation training still requires costly equipment and has lower translational effectiveness for reducing falls in community-ambulatory older adults than overground training. This may be because treadmill perturbation training mainly trains reactive balance control, while falls may also occur due to deficits in volitional balance control which affect gait stability during daily tasks. Volitional balance training has primarily comprised of conventional balance exercises delivered as a part of physical rehabilitation; however, conventional balance exercises generally do not translate to improvements in reactive balance control when exposed to unpredicted perturbations and have limited effects on reducing real-life falls. A fall prevention intervention that targets both volitional and reactive balance control could more effectively reduce falls in at-risk older adults than existing paradigms which only train a single domain (e.g., reactive-dominant treadmill perturbation training or volitional-dominant conventional balance training). We have developed a novel balance training program that includes both volitional-based task-specific exercises and reactive-based predictable perturbations to target the strategies involved in preventing slip- and trip-falls. This task-specific balance training requires little set-up and equipment, making it cost-effective, feasible and accessible. We will examine the immediate effects of 8 weeks (16 sessions) of task-specific balance training on reactive balance (Aim 1) and volitional balance (Aim 2), compared with established fall prevention paradigms (treadmill perturbation training and conventional balance training). Additionally, we will evaluate the longer-term retention (18 months) of task-specific balance training and effects on real-life falls and falls efficacy (Aim 3). In an exploratory aim, we will also examine the neuromuscular adaptations induced through training using muscle synergy analysis (Aim 4). If successful, our novel intervention could be implemented as a feasible, safe, and effective fall prevention intervention, with large potential for direct dissemination to clinical settings.

Interventions

• Behavioral Task-Specific Balance Training
  Participants in the intervention groups will receive 8 weeks of task-specific balance training that includes both functional tasks and predictable perturbations specific to slips and trips. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
• Behavioral Treadmill Perturbation Training
  Participants in the treadmill perturbation training group will receive 8 weeks of training that includes exposure to slip-like and trip-like perturbations delivered via motorized treadmill. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
• Behavioral Conventional Balance Training
  Participants in the conventional balance training group will receive 8 weeks of training that includes conventional exercises designed to improve balance control. Sessions will be completed 2x per week for 8 weeks (16 sessions total).

Primary outcome measures

• Reactive Stability [Time frame: Immediately post and at 18 months]
• Vertical Limb support [Time frame: Immediately post and at 18 months]
• Laboratory falls [Time frame: Immediately post and at 18 months]
• Functional Gait Assessment [Time frame: Baseline, Immediately post and at 18 months]
• Real-life falls [Time frame: Recorded retrospectively (12 months before training) and weekly for 18 months post-training]
• Activities-specific Balance Confidence Scale (ABC) [Time frame: Baseline, Immediately post and at 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Illinois at Chicago — Chicago

Identifiers

NCT: NCT07094659 · 2024-0959 · 2R01AG050672-06A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗