Clinical trial NCT03510377: Effects of Aquatic Intervention on Fall Risk, Hazard Perception, Calendar Planning and Brain Activity During Elderly
Official title: Effects of Aquatic Motor Intervention on Fall Risk, Hazard Perception for Pedestrians, Weekly Calendar Planning and Brain Activity During Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Falling
Pedestrian Accidents
Physical Activity
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: The Science, Technology and Space Ministry, Israel
First posted: 2018-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Volunteers that will meet the inclusion criteria will be randomly divided to three intervention groups.
Primary purpose: PREVENTION

Brief summary: Normal aging is associated with balance, mobility and executive functions decline that increase fall risk and influence Activity of Daily Living (ADL) and Instrumental ADL (IADL) functions such as safe road-crossing, planning and organizing everyday activities. Changes in cerebellar functional plasticity may mediate between the decline in balance, mobility and executive functions during elderly. Fortunately, mounting evidence suggests that physical activity is beneficial for decreasing aging effects and optimize brain structure and function. According to the dynamic systems theory, the environment in which the physical activity occurs influences the results of the activity. We propose an aquatic physical intervention program as a tool to decrease aging effects that in turn might lower fall risk, increase safety of road-crossing and improve planning and organizing everyday activities among community-dwelling older individuals.

Detailed description: The percentage of elderly individuals (65+) in the society of Israel is 10.6%. As life-span increases, this percentage is expected to reach 15% in 2035. According to the Central Bureau of Statistics of Israel regarding the injuries and fatalities of road users, about 14% of the injuries and about 42% of the fatalities are pedestrians. Older pedestrians are about 22% of the pedestrians, twice their part in the population. Ageing effects on balance, mobility and executive functions (especially working memory and inhibitory control) might partially explain these statistics.

Changes in cerebellar functional plasticity may mediate between the decline in balance, mobility and some executive functions during elderly. Studies have shown age-related decrease in structural morphology and function of the cerebellum. The traditional functions of the cerebellum mainly include involvement in the coordination of motor movements, maintenance of balance, and motor learning. Interestingly, studies have found that cerebellar alpha power has an important role in voluntary movement, as well as in higher non-motor cognitive functions such as working memory. Cerebellar activation during working memory task may reﬂect the automated simulation of cognitive operations.

Various forms of physical interventions were found beneficial to promote balance, mobility and executive function of working memory and inhibitory control performances and optimize brain structure and function during elderly. The environment in which the physical intervention occurs is important. Therefore, changing the environment of intervention from on-land to aquatic may result in changing of cerebellar activity, thereby influence on balance, mobility, working memory and inhibitory control abilities proven to be functions connected to the cerebellum.

Due to the characteristics of water (such as density and viscosity), an immersed individual is exposed to physical forces (e.g. specific gravity, thermodynamics and the meta-centric effect) that do not exist on land. Immersion improves balancing abilities by increasing the proprioceptive input to the immersed body. Sensory feedback is increased by promoting a sense of body awareness, as resistance to movement through water is greater than resistance to movement through air. In support of this view, a recent Magnetoencephalography (MEG) study among adults has shown improved verbal working memory ability following one month of intensive aquatic physical intervention. Improved verbal working memory was positively correlated with increased right cerebellar alpha power. In the purpose study we examine the effects of physical intervention in different environments on balance, mobility, working memory and inhibitory control abilities and brain activity in order to decrease aging effects that in turn might lower fall risk, increase safety of road users and improve planning and organizing everyday activities among community-dwelling older individuals.

Eligibility criteria: Inclusion Criteria:

* Score less than 10 on the Geriatric Depression Scale
* Score above 24 in the Mini Mental State Examination

Exclusion Criteria:

* A medical history of neurological, orthopedic and/or psychiatric conditions with permanent impairments, or using drugs that according to the guidelines of the pharmaceutical company may cause dizziness
* Absence of longer than one week from the intervention

Primary outcomes:
measure: Change in the Tinetti balance, gait and fall risk test
timeFrame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
measure: Change in digit span forward and backward tests
timeFrame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
measure: Change in Corsi block forward and backward tests
timeFrame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
measure: Change in the Stroop test
timeFrame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
measure: Change in the weekly calendar planning activity test
timeFrame: Change from Baseline to 3 months of intervention
measure: Change in the hazard perception test for pedestrians
timeFrame: Change from Baseline to 3 months of intervention
measure: Change in brain activity during n-back test
timeFrame: Change from Baseline to 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sackler Faculty of Medicine
Study officials:
affiliation: Tal Aviv University
name: Navah Ratzon, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nissim M, Livny A, Barmatz C, Tsarfaty G, Berner Y, Sacher Y, Giron J, Ratzon NZ. Effects of aquatic physical intervention on fall risk, working memory and hazard-perception as pedestrians in older people: a pilot trial. BMC Geriatr. 2020 Feb 19;20(1):74. doi: 10.1186/s12877-020-1477-4.