Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients

Summary

The goal of this clinical trial is to determine the effectiveness of perturbation-based balance training (PBT) in preventing unrecovered falls among geriatric patients aged ≥70 years with a prospective fall risk of ≥40%. The study will also assess the safety and feasibility of PBT. The main research questions are:

A total of 396 participants will receive 9 training sessions of either PBT or conventional treadmill training and will attend an assessment before and after the intervention, as well as 6 and 12 months follow up. Falls will be documented throughout the entire study period using calendars, telephone interviews, and proxy information. The primary outcome, unrecovered falls, will be recorded after the end of the intervention until 12 months follow up.

Conditions

• Fall Prevention
• Exercise
• Geriatrics
• Cognitive Impairment
• Perturbation

Interventions

OTHER

Conventional Treadmill Walking (CTT)

The CTT serves as a comparison to PBT. It involves standard treadmill walking without perturbations on the same treadmill. This intervention is conducted over the same defined period as PBT (3-6 weeks), with a matched frequency and exercise time compared to the PBT group for consistency. Participants are secured with safety harnesses while walking.

OTHER

Perturbation-Based Balance Training (PBT)

Overall, 9 training sessions with different objectives and progression regarding perturbation directions, predictability, and intensity will be conducted within 3-6 weeks. During the initial sessions, familiarizing participants with the treadmill and establishing their individual walking pace will be focused. Pace can be individually adjusted in each training session. Participants are secured with safety harnesses while walking.

Sponsors & Collaborators

• Marienhospital Herne

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• University of Konstanz

  collaborator OTHER

• University Hospital RWTH Aachen University, Aachen, Germany.

  collaborator UNKNOWN

• Robert Bosch-Krankenhaus Stuttgart

  collaborator UNKNOWN

• Heidelberg University Hospital, Heidelberg, Germany

  collaborator UNKNOWN

• Technische Hochschule Ulm

  collaborator UNKNOWN

• University of Oldenburg

  lead OTHER

Principal Investigators

• Tania Zieschang, Prof. Dr. med. · Carl von Ossietzky University Oldenburg

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-25

Primary Completion

2027-04-30

Completion

2027-04-30

Countries

• Germany

Study Locations