Clinical trial NCT04733222: Effect of Treadmill Perturbation Training on Falls
Official title: Effect of Treadmill Slip- and Trip-perturbation Training on Falls Among Community-dwelling Older Adults: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Accident Prevention
Keywords: Aged
Aged, 80 and over
Exercise
Perturbation training
Older adults
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg Municipality
name: Aalborg University
name: Odense University Hospital
name: University of Southern Denmark
First posted: 2021-02-02
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fall rate
timeFrame: Continuously for 12 months after the initial three training sessions
Secondary outcomes:
measure: Proportion of participants with at least one fall
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Time to first fall
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Fall-related fracture rate
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Proportion of participants with at least one fall-related fractures
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Number of all-cause fractures
timeFrame: At the 52-week follow-up
measure: Number of other fall-related injuries
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Fall-related hospital admission rate
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Proportion of participants with at least one hospital admission
timeFrame: Continuously for 12 months after the initial three training sessions
measure: Number of all-cause hospital admissions
timeFrame: At the 52-week follow-up
measure: Laboratory-induced falls
timeFrame: 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)
measure: Gait kinematics to perturbations
timeFrame: 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)
measure: Single-task gait
timeFrame: 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)
measure: Dual-task gait
timeFrame: 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)
measure: Single-task static balance
timeFrame: 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)
measure: Dual-task static balance
timeFrame: 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)
measure: Choice stepping reaction time
timeFrame: 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)
measure: Lower extremity physical performance
timeFrame: 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)
measure: Health-related quality of life
timeFrame: 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)
measure: Fear of Falling
timeFrame: 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)
measure: Executive function
timeFrame: 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)
measure: Frailty
timeFrame: 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)
measure: Adverse events
timeFrame: 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)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Municipality
Study officials:
affiliation: Aalborg University Hospital and Aalborg University
name: Jens Eg Nørgaard, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norgaard JE, Andersen S, Ryg J, Stevenson AJT, Andreasen J, Danielsen MB, Oliveira ASC, Jorgensen MG. Effects of treadmill slip and trip perturbation-based balance training on falls in community-dwelling older adults (STABILITY): study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 7;12(2):e052492. doi: 10.1136/bmjopen-2021-052492.