NCT Number: NCT06652828
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.
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Geriatric Center, Heidelberg University Hospital, Agaplesion Bethanien Krankenhaus, Heidelberg, Baden-Wurttemberg, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Continuously from intervention end until 12 months after the end of the intervention
Falls are assessed using fall calendars, telephone interviews, and proxy information.
Time frame: Continuously from intervention end until 12 months after the end of the intervention
Falls are assessed using fall calenders, telephone interviews, and proxy information.
Time frame: 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 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.
Time frame: 12 months after the intervention
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.
Time frame: 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
Choice Stepping Reaction Test
Time frame: Before the training intervention (up to 4 weeks before the beginning of the training), and 12 months after the intervention
Montreal Cognitive Assessment (MoCA). Minimum value: 0 points; Maximum value: 30 points; higher values indicate better cognitive functioning.
Time frame: 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
TMT (Trail Making Test)
Time frame: 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
Short Falls Efficacy Scale International (Short FES-I). Minimum value: 7 points, Maximum value: 28 points; higher values indicate more concerns about falling.
Time frame: 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
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
Time frame: 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
2MWT (2 Minute Walk Test )
Time frame: 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
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.
Time frame: 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
TUG (Timed "Up and Go"-Test)
Time frame: 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
MNA (Mini Nutritional Assessment); values of 0-30: lower values indicate worse nutritional status
Time frame: 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)
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.
Time frame: 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)
Spatio-temporal, kinematic and stability parameters (video-based, inertial measurement units and center of pressure data)
Time frame: 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)
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.
Time frame: during the last training session (during the on average 3rd week, at maximum 6th week of the intervention, in the intervention group only)
Theoretical Framework of Acceptability-based Questionnaire
Time frame: 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
Vibration measurement at the inner ankle using a tuning fork. Minimum value: 1 point, Maximum value: 8 points; higher values indicate higher sensation
Time frame: Continuously from baseline assessment until 12 months after the end of the intervention (intervention starts at maximum 4 weeks after baseline assessment)
Intervention-related adverse events
Contact information is provided by the study sponsor or research team.
Jessica PD Dr. Koschate-Storm
CONTACT
Tania Prof. Dr. med. Zieschang
CONTACT
University of Oldenburg
Other
Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment
Acronym: TRAIL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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