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Effect of Treadmill Perturbation Training on Falls

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04733222
Enrollment
140
Registered
2021-02-02
Start date
2021-04-01
Completion date
2022-11-15
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Fall, Accident Prevention

Keywords

Aged, Aged, 80 and over, Exercise, Perturbation training, Older adults

Brief summary

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

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.

Interventions

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).

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.

Sponsors

Aalborg Municipality
CollaboratorOTHER
Aalborg University
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
University of Southern Denmark
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fall rateContinuously for 12 months after the initial three training sessionsFalls are collected by daily recordings in calendar that is returned to the research group monthly

Secondary

MeasureTime frameDescription
Time to first fallContinuously for 12 months after the initial three training sessionsFalls are collected by daily recordings in calendar that is returned to the research group monthly
Fall-related fracture rateContinuously for 12 months after the initial three training sessionsWhen 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.
Proportion of participants with at least one fall-related fracturesContinuously for 12 months after the initial three training sessionsWhen 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.
Number of all-cause fracturesAt the 52-week follow-upScreening of the participants medical records for radiologically verified fractures.
Number of other fall-related injuriesContinuously for 12 months after the initial three training sessionsWhen 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).
Fall-related hospital admission rateContinuously for 12 months after the initial three training sessionsWhen 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.
Proportion of participants with at least one hospital admissionContinuously for 12 months after the initial three training sessionsWhen 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.
Number of all-cause hospital admissionsAt the 52-week follow-upScreening of the participant's medical records
Laboratory-induced fallsWeek 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)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.
Gait kinematics to perturbationsWeek 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 collected before, during and after a slip- and trip-perturbation measured by heel contacts
Proportion of participants with at least one fallContinuously for 12 months after the initial three training sessionsFalls are collected by daily recordings in calendar that is returned to the research group monthly
Dual-task gaitWeek 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)8-meter walking timed by handheld stopwatch under dual-task condition (serial subtraction of threes from a random three digit number).
Single-task static balanceWeek 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)30-seconds static balance measures on a Wii balance board.
Dual-task static balanceWeek 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)30-seconds static balance measures on a Wii balance board under dual-task conditions (verbal fluency of grocery store items).
Choice stepping reaction timeWeek 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 reactions test on a Wii balance board
Lower extremity physical performanceWeek 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)The Short Physical Performance Battery
Health-related quality of lifeWeek 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)The EuroQoL EQ-5D-5L, Danish version
Fear of FallingWeek 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)The Short Falls Efficacy Scale International, Danish version
Executive functionWeek 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)The trail making task Part A and B
FrailtyWeek 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)The Tilburg Frailty Indicator
Adverse eventsWeek 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)Patient-reported events such as muscle soreness, discomfort, pain, or injuries
Single-task gaitWeek 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)8-meter walking timed by handheld stopwatch.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026