Effect of Treadmill Perturbation Training on Falls

Study Overview
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Brief Summary
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This parallel, randomized, controlled trial aims to quantify the effects of slip- and trip-perturbation training on fall rates collected over 12 months, compared to time-matched treadmill walking, among community-dwelling older adults (≥65 years). A sample size calculation estimated that 140 older community-dwelling older adults (≥65 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the perturbation or the walking group. The participants in the perturbation group will be assigned to four perturbation training sessions. The walking group will perform four treadmill walking matching the exercise time of the perturbation training. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from randomization. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess the circumstances and consequences (e.g., fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological outcomes will be made at baseline, post-test, six-month, and 12-months reassessment.

Detailed Description
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Approximately one-third of older adults fall at least once a year, and about 10% of these falls cause serious injuries such as head injuries and fractures. In fact, falls are the most frequent cause of injuries among older adults and often lead to disability, institutionalization, and premature death. Multiple fall prevention interventions have been examined to reduce the fall rate, and physical exercise has continuously been proven as an effective and cost-effective approach. However, traditional exercise approaches, such as balance and muscle-strengthening training, have only shown a moderate 20-25% decrease in falls and encounters issues such as poor compliance. Recently, task-specific perturbation training using an overground walkway has been shown to produce quick motor adaptations resulting in improved pro- and reactive stability. Additionally, perturbation training delivered on such walkways has decreased both laboratory-induced and real-life falls. However, overground walkways with moveable platforms and trip-board are expensive and immobile; thus, limiting the clinical feasibility. Contrarily, perturbation training delivered on computer-controlled treadmills may serve as a more implementable substitute. Preliminary studies have shown that treadmill perturbation training produces similar dynamic stability adaptations to overground perturbation training. Furthermore, a single session of treadmill perturbation decreases the rate of laboratory-induced falls, and the ergogenic effects were retained for up to six months. However, the effects of a brief treadmill perturbation training intervention on real-life falls in community-dwelling older adults still vastly unknown.

Official Title
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Effect of Treadmill Slip- and Trip-perturbation Training on Falls Among Community-dwelling Older Adults: A Randomized, Controlled Trial

Conditions
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Accidental Fall, Accident Prevention

Intervention / Treatment
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* Other: Perturbation training
* Other: Treadmill walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥65 years old Community-dwelling Able to walk without a walking aid Exclusion Criteria: Any of the following self-reported conditions: Any orthopedic surgery within the past 12 months, osteoporosis or history of osteoporosis-related fractures (low impact hip, spine, and wrist fracture), or progressive neurological disease (e.g., Parkinson, multiple sclerosis) An unstable medical condition that would prevent safe participation Severe cognitive impairment (a score <8 in The Short Orientation-Memory-Concentration Test) Current participation in another fall prevention trial

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After the pre-training tests, participants will be randomly allocated to either the perturation or control group. To produce groups of similar size a permuted block randomization will be used. Allocation concealment will be maintained using random block sizes (4, 6, or 8) and by the randomization code only being available for non-blinded research staff. The perturbation group will undergo three initial training sessions on two days within a week, and a booster-session after six months. The active control group will perform treadmill walking at a preferred speed to match the training dose of the perturbations group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perturbation training<br>Participants randomized to the treadmill perturbation training will initially perform three sessions performed within a week followed by a booster-session after six months. | Other: Perturbation training<br>* The treadmill perturbation training will be performed on a computer-controlled treadmill. The perturbation will be induced by fast forward (slip) or backward (trip) accelerations of the treadmill at specific gait cycle timings. The perturbations will be delivered randomly to enhance the unpredictability. A ceiling-mounted body-harness ensures the safety of the participants. Participants will be assigned to three initial sessions of treadmill slip- and trip-perturbation training on two days separated by a week and a booster-session after six months. On day 1, participants will first undergo a session 1 with 40 slip perturbations and then a session 2 with 40 trip perturbations. On day 2, participants will undergo a session 3 with 20 slip and 20 trip perturbations in random order. The booster-session after six months will be similar to session 3 (20 of each perturbation in random order).<br>|
| Active Comparator: Treadmill walking<br>Participants randomized to the walking group will undergo three initial sessions within a week and a booster-session after six months. | Other: Treadmill walking<br>* Participants allocated to the walking group will walk at a self-selected pace on a computer-controlled treadmill for the same amount of time as the treadmill perturbation training participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall rate | Falls are collected by daily recordings in calendar that is returned to the research group monthly | Continuously for 12 months after the initial three training sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with at least one fall | Falls are collected by daily recordings in calendar that is returned to the research group monthly | Continuously for 12 months after the initial three training sessions | 
| Time to first fall | Falls are collected by daily recordings in calendar that is returned to the research group monthly | Continuously for 12 months after the initial three training sessions | 
| Fall-related fracture rate | When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. fractures). Screening of the participants medical records for radiologically verified fractures will verify this information. | Continuously for 12 months after the initial three training sessions | 
| Proportion of participants with at least one fall-related fractures | When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. fractures). Screening of the participants medical records for radiologically verified fractures will verify this information. | Continuously for 12 months after the initial three training sessions | 
| Number of all-cause fractures | Screening of the participants medical records for radiologically verified fractures. | At the 52-week follow-up | 
| Number of other fall-related injuries | When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. head injuries and bruises). | Continuously for 12 months after the initial three training sessions | 
| Fall-related hospital admission rate | When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. hospital contacts). Screening of the participant's medical records will verify this information. | Continuously for 12 months after the initial three training sessions | 
| Proportion of participants with at least one hospital admission | When a fall is registered in the fall calendar, a research group member will make a telephone interview to obtain information about the fall's consequences (e.g. hospital contacts). Screening of the participant's medical records will verify this information. | Continuously for 12 months after the initial three training sessions | 
| Number of all-cause hospital admissions | Screening of the participant's medical records | At the 52-week follow-up | 
| Laboratory-induced falls | Falls after slips and trips induced on the treadmill. A fall is determined based on video recordings. A fall is defined as unambiguous support by the safety harness after the perturbation. | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Gait kinematics to perturbations | Gait kinematics collected before, during and after a slip- and trip-perturbation measured by heel contacts | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Single-task gait | 8-meter walking timed by handheld stopwatch. | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Dual-task gait | 8-meter walking timed by handheld stopwatch under dual-task condition (serial subtraction of threes from a random three digit number). | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Single-task static balance | 30-seconds static balance measures on a Wii balance board. | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Dual-task static balance | 30-seconds static balance measures on a Wii balance board under dual-task conditions (verbal fluency of grocery store items). | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Choice stepping reaction time | Choice stepping reactions test on a Wii balance board | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Lower extremity physical performance | The Short Physical Performance Battery | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Health-related quality of life | The EuroQoL EQ-5D-5L, Danish version | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Fear of Falling | The Short Falls Efficacy Scale International, Danish version | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Executive function | The trail making task Part A and B | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Frailty | The Tilburg Frailty Indicator | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 
| Adverse events | Patient-reported events such as muscle soreness, discomfort, pain, or injuries | Week 0 (Pre-training; before the first training), week 1 (Post-training; after the third training session), week 26 (26-week follow-up; before the fourth training session), and week 52 (52-week follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged, Aged, 80 and over, Exercise, Perturbation training, Older adults