Clinical trial NCT04087512: Instrumented vs. Conventional Perturbation-based Balance Training for Fall Prevention
Official title: Comparison of an Instrumented and a Conventional Perturbation-Based Balance Training for Preventing Falls in Older Persons
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fall Risk, Fall Prevention
Keywords: perturbation-based balance training
exercise
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Humboldt-Universität zu Berlin
First posted: 2019-09-12
Enrollment: 71
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the past years, several studies have demonstrated the potential of task-specific perturbation-based balance training (PBT) for preventing falls at age. However, different paradigms of PBT have been investigated so far, while a comparison of these paradigms is lacking. Therefore, in this study, we plan to compare two promising PBT approaches in terms of feasibility and effects on fall risk-associated motor performance: 1. Training of dynamic stability mechanisms in the presence of perturbations induced by unstable surfaces; 2. Technology-supported training on a perturbation treadmill. In addition, both approaches will be compared with a passive control group. One-hundred and eleven participants aged 65 years or older will be randomly assigned to the three arms of the study. As the primary outcome, we will assess fall risk by use of the Brief-BESTest. Secondary outcomes include balance performance, functional performance, force capacity, and more. We hypothesize that both interventions will lead to a significant reduction of fall risk compared to the control group. Additionally, we will explore whether one of the two PBT paradigms is superior regarding feasibility and effectiveness.


Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older
* Speaks German language
* Home-dwelling or assisted living
* One fall in the past 12 months OR a verified fall risk (based on subjective decreased balance AND extended Short Physical Performance Battery (SPPB) balance testing
* Able to walk at least 20 minutes without aid
* Available for intervention period

Exclusion Criteria:

* Participation in balance training in the previous 3 months
* DemTec ≤ 8 Points
* Body mass index \> 30
* Uncorrected vision disorder
* Acute serious neurological disability affecting gait pattern
* Serious sensory disorders
* Severe cardiovascular or metabolic disorders
* Orthopaedic restrictions or diseases
* Strong dizziness
* Current chemotherapy
* Severe respiratory disease

Primary outcomes:
measure: Balance performance
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
Secondary outcomes:
measure: Neuromuscular control during perturbations
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Reactive balance performance
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Static balance performance
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Limits of stability
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Spatio-temporal gait parameters
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Functional leg strength (a)
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Functional leg strength (b)
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Force capacity of knee extensors
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Fear of falling
timeFrame: Change from baseline to post intervention test (an average of 7 weeks)
measure: Feasibility of training paradigms
timeFrame: Post intervention test (on average 7 weeks after baseline)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University, Network Aging Research
Study officials:
References: