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Completed

NCT Number: NCT04733222

Effect of Treadmill Perturbation Training on Falls

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.

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Key information

Conditions

Accidental Fall Accident Prevention Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Municipality

Aalborg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perturbation training

Other

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).

Treadmill walking

Other

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.

Primary outcomes

  1. Fall rate

    Time frame: Continuously for 12 months after the initial three training sessions

    Falls are collected by daily recordings in calendar that is returned to the research group monthly

Secondary outcomes

  1. Proportion of participants with at least one fall

    Time frame: Continuously for 12 months after the initial three training sessions

    Falls are collected by daily recordings in calendar that is returned to the research group monthly

  2. Time to first fall

    Time frame: Continuously for 12 months after the initial three training sessions

    Falls are collected by daily recordings in calendar that is returned to the research group monthly

  3. Fall-related fracture rate

    Time frame: Continuously for 12 months after the initial three training sessions

    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.

  4. Proportion of participants with at least one fall-related fractures

    Time frame: Continuously for 12 months after the initial three training sessions

    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.

  5. Number of all-cause fractures

    Time frame: At the 52-week follow-up

    Screening of the participants medical records for radiologically verified fractures.

  6. Number of other fall-related injuries

    Time frame: Continuously for 12 months after the initial three training sessions

    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).

  7. Fall-related hospital admission rate

    Time frame: Continuously for 12 months after the initial three training sessions

    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.

  8. Proportion of participants with at least one hospital admission

    Time frame: Continuously for 12 months after the initial three training sessions

    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.

  9. Number of all-cause hospital admissions

    Time frame: At the 52-week follow-up

    Screening of the participant's medical records

  10. Laboratory-induced falls

    Time frame: 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)

    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.

  11. Gait kinematics to perturbations

    Time frame: 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 collected before, during and after a slip- and trip-perturbation measured by heel contacts

  12. Single-task gait

    Time frame: 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)

    8-meter walking timed by handheld stopwatch.

  13. Dual-task gait

    Time frame: 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)

    8-meter walking timed by handheld stopwatch under dual-task condition (serial subtraction of threes from a random three digit number).

  14. Single-task static balance

    Time frame: 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)

    30-seconds static balance measures on a Wii balance board.

  15. Dual-task static balance

    Time frame: 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)

    30-seconds static balance measures on a Wii balance board under dual-task conditions (verbal fluency of grocery store items).

  16. Choice stepping reaction time

    Time frame: 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 reactions test on a Wii balance board

  17. Lower extremity physical performance

    Time frame: 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)

    The Short Physical Performance Battery

  18. Health-related quality of life

    Time frame: 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)

    The EuroQoL EQ-5D-5L, Danish version

  19. Fear of Falling

    Time frame: 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)

    The Short Falls Efficacy Scale International, Danish version

  20. Executive function

    Time frame: 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)

    The trail making task Part A and B

  21. Frailty

    Time frame: 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)

    The Tilburg Frailty Indicator

  22. Adverse events

    Time frame: 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)

    Patient-reported events such as muscle soreness, discomfort, pain, or injuries

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aalborg Municipality
  • Aalborg University
  • Odense University Hospital
  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2021
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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