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

NCT06652828 | Recruiting DMC

• 2 other identifiers: 2022-UOL-MG-005-0101KG2303
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

treadmill; unrecovered falls; fall risk; training; falls; balance; rehabilitaion

Outcome Measures

Primary Outcomes (1)

• Rate of unrecovered falls

  Falls are assessed using fall calendars, telephone interviews, and proxy information.

  Continuously from intervention end until 12 months after the end of the intervention

Secondary Outcomes (17)

• Rate of falls

  Continuously from intervention end until 12 months after the end of the intervention

• Physical activity

  Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention

• Stepping response (a)

  12 months after the intervention

• Stepping reponse (b)

  Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention

• Cognitive functioning (a)

  Before the training intervention (up to 4 weeks before the beginning of the training), and 12 months after the intervention

Other Outcomes (1)

• Assessment of safety

  Continuously from baseline assessment until 12 months after the end of the intervention (intervention starts at maximum 4 weeks after baseline assessment)

Study Arms (2)

Conventional Treadmill Training (CTT)

ACTIVE COMPARATOR

Other: Conventional Treadmill Walking (CTT)

Perturbation-Based Balance Training (PBT)

EXPERIMENTAL

Other: Perturbation-Based Balance Training (PBT)

Interventions

Conventional Treadmill Walking (CTT) OTHER

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.

Also known as: Exercise intervention

Conventional Treadmill Training (CTT)

Perturbation-Based Balance Training (PBT) OTHER

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.

Also known as: Gait adaptability training, Reactive balance training

Perturbation-Based Balance Training (PBT)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 70 years
• ≥40% prospective fall risk for the following year according to the Fall Risk Assessment Tool (FRAT-up)
• Walking distance ≥ 70 m in the 2 Minute Walk Test
• Possibility to reach the study site at least via taxi
• Written informed consent, obtained according to international guidelines and local laws

You may not qualify if:

• MoCA score \< 10 pts (or MMSE \< 17 pts)
• Performing a Timed up and Go test (TUG) \<10 s
• Leg amputation
• Osteosynthesis or joint replacement of lower extremities within the past 6 weeks.
• Blindness
• Parkinson's disease with Hoehn and Yahr stage \> 3
• Body weight \>135 kg and height \>185 cm
• Life-expectancy \<12 months, instable or severe illness
• Inability to communicate verbally and coorporate appropriatly
• (Prior) participation perturbation training programs
• Gait-relevant foot-drop paresis

Sponsors & Collaborators

• University of Oldenburg: lead
• Marienhospital Herne: collaborator
• University of Ulm: collaborator
• University of Konstanz: collaborator
• University Hospital RWTH Aachen University, Aachen, Germany.: collaborator
• Robert Bosch-Krankenhaus Stuttgart: collaborator
• Heidelberg University Hospital, Heidelberg, Germany: collaborator
• Technische Hochschule Ulm: collaborator

Study Sites (3)

Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

Department of Geriatric Medicine, University Hospital Marien Hospital Herne - Ruhr-University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

RECRUITING

Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie

Oldenburg, 26129, Germany

RECRUITING

Related Publications (1)

• Koschate-Storm J, Werner C, Bartel J, Bauer JM, Becker C, Drefs S, El-Seoud N, Giehl C, Hackbarth M, Hezel N, Klenk J, Trampisch U, Wirth R, Zieschang T, Schwenk M. Treadmill perturbation-based balance training to prevent unrecovered falls in fall-prone older adults with and without cognitive impairment: protocol for the multi-center randomized controlled TRAIL study. BMC Geriatr. 2025 Dec 23. doi: 10.1186/s12877-025-06599-w. Online ahead of print.

  PMID: 41436967 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Motor Activity; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tania Zieschang, Prof. Dr. med.

  Carl von Ossietzky University Oldenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania Prof. Dr. med. Zieschang

CONTACT

+49 441 798-4760; tania.zieschang@uol.de

Jessica PD Dr. Koschate-Storm

CONTACT

+49 441 798-4760; jessica.koschate-storm@uol.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available for 10 years after the last publication of the study results.
• Access Criteria: Data will be made available upon reasonable request via e-mail.

Locations

DE (3)