Effect of Treadmill Perturbation Training on Falls

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.

Conditions

• Accidental Fall
• Accident Prevention

Interventions

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).

OTHER

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.

Sponsors & Collaborators

• Aalborg Municipality

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Aalborg University Hospital

  lead OTHER

Principal Investigators

• Jens Eg Nørgaard, MSc · Aalborg University Hospital and Aalborg University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2022-11-15

Completion

2022-11-15

Countries

• Denmark

Study Locations