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

University of Oldenburg

Status

Enrolling

Conditions

Geriatrics

Cognitive Impairment

Perturbation

Exercise

Fall Prevention

Treatments

Other: Conventional Treadmill Walking (CTT)

Other: Perturbation-Based Balance Training (PBT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06652828

01KG2303 (Other Grant/Funding Number)

2022-UOL-MG-005-01

Details and patient eligibility

About

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.

Full 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).

Enrollment

396 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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