Clinical trial NCT06652828: Perturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients
Official title: Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall Prevention
Exercise
Geriatrics
Cognitive Impairment
Perturbation
Keywords: treadmill
unrecovered falls
fall risk
training
falls
balance
rehabilitaion
Lead sponsor: University of Oldenburg
Sponsor class: OTHER
Collaborators: name: Marienhospital Herne
name: University of Ulm
name: University of Konstanz
name: University Hospital RWTH Aachen University, Aachen, Germany.
name: Robert Bosch-Krankenhaus Stuttgart
name: Heidelberg University Hospital, Heidelberg, Germany
name: Technische Hochschule Ulm
First posted: 2024-10-22
Enrollment: 396
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of unrecovered falls
timeFrame: Continuously from intervention end until 12 months after the end of the intervention
Secondary outcomes:
measure: Rate of falls
timeFrame: Continuously from intervention end until 12 months after the end of the intervention
measure: Physical activity
timeFrame: 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
measure: Stepping response (a)
timeFrame: 12 months after the intervention
measure: Stepping reponse (b)
timeFrame: 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
measure: Cognitive functioning (a)
timeFrame: Before the training intervention (up to 4 weeks before the beginning of the training), and 12 months after the intervention
measure: Cognitive functioning (b)
timeFrame: 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
measure: Concerns about falling
timeFrame: 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
measure: Health-related quality of life
timeFrame: 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
measure: Physical capacity (a)
timeFrame: 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
measure: Physical capacity (b)
timeFrame: 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
measure: Physical capacity (c)
timeFrame: 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
measure: Nutritional status
timeFrame: 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
measure: Reactive dynamic balance (a)
timeFrame: 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)
measure: Reactive dynamic balance (b)
timeFrame: 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)
measure: Laboratory falls
timeFrame: 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)
measure: Acceptability of PBT
timeFrame: during the last training session (during the on average 3rd week, at maximum 6th week of the intervention, in the intervention group only)
measure: Vibration sensation
timeFrame: 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 outcomes:
measure: Assessment of safety
timeFrame: Continuously from baseline assessment until 12 months after the end of the intervention (intervention starts at maximum 4 weeks after baseline assessment)
Locations:
city: Heidelberg
country: Germany
facility: Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus
state: Baden-Württemberg
city: Herne
country: Germany
facility: Department of Geriatric Medicine, University Hospital Marien Hospital Herne - Ruhr-University Bochum
state: Nordrhein-Westfalen
city: Oldenburg
country: Germany
facility: Carl von Ossietzky Universität, Department für Versorgungsforschung, Abteilung Geriatrie
Study officials:
affiliation: Carl von Ossietzky University Oldenburg
name: Tania Zieschang, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: