Effect of Treadmill Perturbation Training on Falls

Accidental Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733222
• Other study ID #: N-20200089
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: January 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accident Prevention
• Accidental Fall

Intervention

Other:
• Perturbation training
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
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.

Locations

Country	Name	City	State
Denmark	Aalborg Municipality	Aalborg

Sponsors (5)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aalborg Municipality, Aalborg University, Odense University Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of all-cause fractures	Screening of the participants medical records for radiologically verified fractures.	At the 52-week follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of all-cause hospital admissions	Screening of the participant's medical records	At the 52-week follow-up
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)