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

Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Exercise; Geriatrics; Fall Prevention; Perturbation
• Intervention / Treatment: Other: Conventional Treadmill Walking (CTT); Other: Perturbation-Based Balance Training (PBT)

Detailed Description

Falls are common and the leading cause of injuries among older adults, but falls may be attenuated by the promising and time-efficient intervention called perturbation-based balance training (PBT). The aim of the TRAIL-study is to confirm the effectiveness of a treadmill PBT protocol for preventing unrecovered falls in geriatric patients with and without cognitive impairment. This study is designed as a confirmatory, multicenter, assessor-blinded, randomized controlled study. The 396 geriatric patients aged ≥70 years with ≥40% prospective fall risk and being capable of walking ≥70 m in a 2-Minute Walk Test will receive 9 sessions of PBT on a treadmill (intervention) or a conventional treadmill training (control group; CTT).

Outcome assessments will be performed shortly after the intervention interval as well as 6 and 12 months thereafter. The primary outcome is defined as unrecovered falls (defined as falls in which persons who fell are unable to get up independently) within 12-month follow-up. Falls are documented over at least 12 months using calendars, telephone interviews, and proxy information. Secondary outcomes include mobility, balance performance, concerns about falling, physical activity and capacity, stepping responses, health-related quality of life, cognitive functioning, mobility, reactive dynamic balance and training acceptability of PBT. The study will be accompanied by a patient advisory board and an expert advisory board and focus groups will be conducted to involve the target group.

Based on pilot studies and the available literature, we expect a ≥50% reduction of unrecovered falls during the following year in the intervention group (PBT) compared to the control group (CTT).

• Study Type: Interventional
• Enrollment (Estimated): 396
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania Prof. Dr. med. Zieschang; Phone Number: +49 441 798-4760; Email: tania.zieschang@uol.de
• Study Contact Backup: Name: Jessica PD Dr. Koschate-Storm; Phone Number: +49 441 798-4760; Email: jessica.koschate-storm@uol.de

Study Locations

• Germany
  • Oldenburg, Germany, 26129
    • Recruiting
    • Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie
    • Contact: Tania Zieschang, Prof. Dr. med.; Phone Number: +49 441 798-4760; Email: tania.zieschang@uol.de
    • Contact: Jessica Koschate-Storm, PD Dr.; Phone Number: +49 441 798-4760; Email: jessica.koschate-storm@uol.de
    • Principal Investigator: Tania Zieschang, Prof. Dr. med.
    • Sub-Investigator: Jessica Koschate-Storm, PD Dr.
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Recruiting
      • Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus
      • Contact: Clemens Becker, Prof. Dr.; Phone Number: 496221-319-1759; Email: Clemens.becker@rbk.de
      • Contact: Christian Werner, Dr.; Phone Number: +496221-319-1759; Email: christian.werner@med.uni-heidelberg.de
      • Principal Investigator: Clemens Becker, Prof. Dr. med.
      • Sub-Investigator: Christian Werner, Dr.
  • Nordrhein-Westfalen
    • Herne, Nordrhein-Westfalen, Germany, 44625
      • Recruiting
      • Department of Geriatric Medicine, University Hospital Marien Hospital Herne - Ruhr-University Bochum
      • Contact: Rainer Wirth, Prof. Dr. med.; Phone Number: +49 2323 - 499 - 3387; Email: Rainer.wirth@elisabethgruppe.de
      • Contact: Ulrike Trampisch, Dr.; Phone Number: +49 2323 - 499 - 3387; Email: Ulrike.Trampisch@elisabethgruppe.de
      • Principal Investigator: Rainer Wirth, Prof. Dr. med.
      • Sub-Investigator: Ulrike Trampisch, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perturbation-Based Balance Training (PBT)	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.; Other Names: Gait adaptability training; Reactive balance training
Active Comparator: Conventional Treadmill Training (CTT)	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 Names: Exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concerns about falling	Short Falls Efficacy Scale International (Short FES-I). Minimum value: 7 points, Maximum value: 28 points; higher values indicate more concerns about falling.	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
Rate of falls	Falls are assessed using fall calenders, telephone interviews, and proxy information.	Continuously from intervention end until 12 months after the end of the intervention
Physical activity	Physical activity will be measured over 7 days using a body-fixed inertial measurement unit (AX6, Axivity Ltd., Newcastle, UK) , which will be placed at lumbar level (L5) of the participant. The sensor measures linear acceleration data in 3 dimensions in combination with angular data. From these data, besides others, time spent with physical activity, steps as well as time spent in the supine sitting or standing position can be determined and reported. Data will be used to describe the participants and to report falls per 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)	Modified Stepping Threshold Tests (i.e. single step, multiple step threshold). Participants will experience suface perturbations in ante-posterior as well as mediolateral direction with increasing intensity until they have to perform a single compensatory step or multiple steps to recover balance. Higher perturbation levels for the single or multiple step threshold indicate better static reactive balance.	12 months after the intervention
Stepping reponse (b)	Choice Stepping Reaction Test	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)	Montreal Cognitive Assessment (MoCA). Minimum value: 0 points; Maximum value: 30 points; higher values indicate better cognitive functioning.	Before the training intervention (up to 4 weeks before the beginning of the training), and 12 months after the intervention
Cognitive functioning (b)	TMT (Trail Making Test)	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
Health-related quality of life	Euro Quality of Life with visual analogue scales (EQ-VAS), values of 0-100: lower values indicate worse subjective health; EuroQol 5-Dimensions 5-Levels	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
Physical capacity (a)	2MWT (2 Minute Walk Test )	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
Physical capacity (b)	SPPB (Short Physical Performance Battery), including balance, leg strength and gait speed; minimum value: 0 points; maximum value: 12 points; higher values indicate better physical capacity.	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
Physical capacity (c)	TUG (Timed "Up and Go"-Test)	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
Nutritional status	MNA (Mini Nutritional Assessment); values of 0-30: lower values indicate worse nutritional status	Before the training intervention (up to 4 weeks before the beginning of the training), 6 months after the intervention, and 12 months after the intervention
Reactive dynamic balance (a)	Adapted Compensatory Arm and Leg Movements after perturbations induced on the treadmill during walking. Minimum value: 16 points; Maximum value: 108 points; higher values indicate better reactive dynamic balance.	3rd (during the on average 1st week of the intervention) and last training session (during the on average 3rd week, at maximum 6th week of the intervention) (intervention group only), and 12 months after the intervention (intervention and control group)
Reactive dynamic balance (b)	Spatio-temporal, kinematic and stability parameters (video-based, inertial measurement units and center of pressure data)	3rd (during the on average 1st week of the intervention) and last training session (during the on average 3rd week, at maximum 6th week of the intervention) (intervention group only), and 12 months after the intervention (intervention and control group)
Laboratory falls	Falls after perturbations 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.	during 3rd (on average 1st week of the intervention) and last training session (on average 3rd week, at maximum 6th week of the intervention; intervention group only), and 12 months after the intervention (intervention and control group)
Acceptability of PBT	Theoretical Framework of Acceptability-based Questionnaire	during the last training session (during the on average 3rd week, at maximum 6th week of the intervention, in the intervention group only)
Vibration sensation	Vibration measurement at the inner ankle using a tuning fork. Minimum value: 1 point, Maximum value: 8 points; higher values indicate higher sensation	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of safety	Intervention-related adverse events	Continuously from baseline assessment until 12 months after the end of the intervention (intervention starts at maximum 4 weeks after baseline assessment)

Collaborators and Investigators

• Sponsor: University of Oldenburg
• Collaborators: University of Ulm; University of Konstanz; Marienhospital Herne; Heidelberg University Hospital, Heidelberg, Germany; University Hospital RWTH Aachen University, Aachen, Germany.; Robert Bosch-Krankenhaus Stuttgart; Technische Hochschule Ulm
• Investigators: Principal Investigator: Tania Zieschang, Prof. Dr. med., Carl von Ossietzky University Oldenburg

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: falls; training; balance; fall risk; treadmill; unrecovered falls; rehabilitaion
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2022-UOL-MG-005-01; 01KG2303 (Other Grant/Funding Number: BMBF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon reasonable request via e-mail.
• IPD Sharing Time Frame: The data will be available for 10 years after the last publication of the study results.
• IPD Sharing Access Criteria: Data will be made available upon reasonable request via e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No