AgingNCT03510377
Effects of Aquatic Intervention on Fall Risk, Hazard Perception, Calendar Planning and Brain Activity During Elderly
A study testing Aquatic physical intervention, On-land physical intervention and Non physical intervention in people with Aging and Falling, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Falling, Pedestrian Accidents
- What is being tested?
- Aquatic physical intervention, On-land physical intervention and Non physical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Score less than 10 on the Geriatric Depression Scale
- Score above 24 in the Mini Mental State Examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aquatic Motor Intervention on Fall Risk, Hazard Perception for Pedestrians, Weekly Calendar Planning and Brain Activity During Elderly
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.
Read the 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.
- Conditions
- Aging, Falling, Pedestrian Accidents, Physical Activity
- Being tested
- Aquatic physical intervention, On-land physical intervention, Non physical intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic physical interventionOther
For structured aquatic physical intervention group, the Ai-Chi method was selected. Ai-Chi is a simple aquatic exercise and relaxation method that uses a combination of deep breathing and slow movements of the arms, legs and torso in continual flowing patterns. The Ai-Chi intervention will occur in an hydrotherapy pool (34C).
On-land physical interventionOther
For controlled comparison of the structured physical intervention group the Tai-Chi method was selected (the same movements as the Ai-Chi). The Tai-Chi intervention will occur in a room.
Non physical interventionOther
The people who will be part of the non physical intervention will practice guided imagery of the Ai-Chi method. The guided imagery intervention will occur in a room.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic physical intervention | Experimental | Aquatic physical intervention: Ai-Chi Receives: Other: Aquatic physical intervention; Other: On-land physical intervention; Other: Non physical intervention |
| On-land physical intervention | Experimental | On-land physical intervention: Tai-Chi Receives: Other: Aquatic physical intervention; Other: On-land physical intervention; Other: Non physical intervention |
| Non physical intervention | Experimental | Non physical intervention: Guided imagery Receives: Other: Aquatic physical intervention; Other: On-land physical intervention; Other: Non physical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Tinetti balance, gait and fall risk test
This test is a standardized evaluation of balance and mobility designed to determine risk for falls during elderly. It has a very good inter-rater reliability and sensitivity. The gait testing included initiation of gait, step height, step length, step symmetry, step continuity, path deviation, trunk stability, walk stance, and turning while walking. Each item scored 1 if normal or 0 if abnormal. The balance testing included sitting balance, arising from chair, immediate standing, standing balance, balance with eyes closed, turning balance, neck turning, back extension, one-leg standing, push test, reaching up, bending down, and sitting down. Each item scored 1 (normal) or 0 (abnormal). Tinetti scores for risk of falls: ≤18 points=high risk; 19-23 points=moderate risk; ≥24 points =low risk.
Measured: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
Change in digit span forward and backward tests
During the task a sequence of digits is read by the experimenter at a rate of 1/second, and participants is asked to recall the digits in forward or backward order immediately after hearing them. The task starting with a sequence of two digits, the number of digits per sequence will increase by one if a participant successfully recall a given sequence length twice. Testing will end when the participant makes errors on two successive trials of a given length. Performance will express as the number of sequences successfully recall.
Measured: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
Change in Corsi block forward and backward tests
During the tasks the subject watches the tester touch a series of blocks (one block per second), then the subject is to touch the blocks in the same order or backward. The task starting with one block, the blocks per sequence will increase by one if a participant successfully recall a given sequence length twice. Testing will end when the participant makes errors on two successive trials of a given length. Performance will express as the number of sequences successfully recall.
Measured: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
Change in the Stroop test
This task measures inhibitory control which is one of the core elements of executive functions. The task involves showing words that are the names of colors. The letters making up each word are printed in a color of ink different from the color name the word represents. The participant is asked to quickly respond with the color ink he sees, and inhibit the printed word. Performance will express the time (in seconds) it takes to finish the task and accuracy.
Measured: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
Change in the weekly calendar planning activity test
This tool was designed to be useful across a variety of populations that exhibit difficulties in executive functioning. It provides a broad analysis of how a person manages and copes with a complex and cognitively challenging activity. In addition to including a weekly schedule, the assessment features client profiles on error analysis, visual performance, awareness of task difficulty, and pre/post comparisons. The Weekly Calendar Planning Activity has three levels of difficulty, from Level 1, the easiest, in which appointments are preordered, to Level 3, the most difficult, in which appointments are randomly ordered in paragraph form. We will use Level 2 for this study, In Level 2 the participant is presented with a list of appointments in random order they have to schedule during 1 week by filling in a paper calendar.
Measured: Change from Baseline to 3 months of intervention
Change in the hazard perception test for pedestrians
This computerized test was aimed to test and train pedestrians to safe cross walking and detect on road hazards as soon as possible.
Measured: Change from Baseline to 3 months of intervention
Change in brain activity during n-back test
Functional Magnetic Resonance Imaging (fMRI) is a non-invasive technology. The fMRI paradigm consists of 5 minutes resting-state and an N-back task. We will use the 3.0 Tesla Siemens Prisma MRI Scanner located in Tel-Aviv University.
Measured: Change from Baseline to 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers that will meet the inclusion criteria will be randomly divided to three intervention groups.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- The Science, Technology and Space Ministry, Israel
- Responsible party
- Principal investigator, Navah Ratzon, Tel Aviv University
- Investigators
- Navah Ratzon, Prof., Principal investigator, Tal Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510377
- Sponsor's protocol ID
- Michal Nissim
- Status last verified
- Jan 2020
- First submitted
- 31 Oct 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32075583
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Motor Intervention on Fall Risk, Hazard Perception for Pedestrians, Weekly Calendar Planning and Brain Activity During Elderly
- ClinicalTrials.gov ID
- NCT03510377
- Acronym / sponsor ID
- Michal Nissim
- Conditions
- Aging, Falling, Pedestrian Accidents, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- The Science, Technology and Space Ministry, Israel
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Volunteers that will meet the inclusion criteria will be randomly divided to three intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Aquatic physical intervention | Experimental | Other: Aquatic physical intervention, Other: On-land physical intervention, Other: Non physical interventionAquatic physical intervention: Ai-Chi |
| On-land physical intervention | Experimental | Other: Aquatic physical intervention, Other: On-land physical intervention, Other: Non physical interventionOn-land physical intervention: Tai-Chi |
| Non physical intervention | Experimental | Other: Aquatic physical intervention, Other: On-land physical intervention, Other: Non physical interventionNon physical intervention: Guided imagery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Score less than 10 on the Geriatric Depression Scale
- Score above 24 in the Mini Mental State Examination
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic physical interventionFor structured aquatic physical intervention group, the Ai-Chi method was selected. Ai-Chi is a simple aquatic exercise and relaxation method that uses a combination of deep breathing and slow movements of the arms, legs and torso in continual flowing patterns. The Ai-Chi intervention will occur in an hydrotherapy pool (34C). | Other | Aquatic physical intervention, Non physical intervention, On-land physical intervention |
| On-land physical interventionFor controlled comparison of the structured physical intervention group the Tai-Chi method was selected (the same movements as the Ai-Chi). The Tai-Chi intervention will occur in a room. | Other | Aquatic physical intervention, Non physical intervention, On-land physical intervention |
| Non physical interventionThe people who will be part of the non physical intervention will practice guided imagery of the Ai-Chi method. The guided imagery intervention will occur in a room. | Other | Aquatic physical intervention, Non physical intervention, On-land physical intervention |
Primary outcome
Change in the Tinetti balance, gait and fall risk test
Time frame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
This test is a standardized evaluation of balance and mobility designed to determine risk for falls during elderly. It has a very good inter-rater reliability and sensitivity. The gait testing included initiation of gait, step height, step length, step symmetry, step continuity, path deviation, trunk stability, walk stance, and turning while walking. Each item scored 1 if normal or 0 if abnormal. The balance testing included sitting balance, arising from chair, immediate standing, standing balance, balance with eyes closed, turning balance, neck turning, back extension, one-leg standing, push test, reaching up, bending down, and sitting down. Each item scored 1 (normal) or 0 (abnormal). Tinetti scores for risk of falls: ≤18 points=high risk; 19-23 points=moderate risk; ≥24 points =low risk.
Change in digit span forward and backward tests
Time frame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
During the task a sequence of digits is read by the experimenter at a rate of 1/second, and participants is asked to recall the digits in forward or backward order immediately after hearing them. The task starting with a sequence of two digits, the number of digits per sequence will increase by one if a participant successfully recall a given sequence length twice. Testing will end when the participant makes errors on two successive trials of a given length. Performance will express as the number of sequences successfully recall.
Change in Corsi block forward and backward tests
Time frame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
During the tasks the subject watches the tester touch a series of blocks (one block per second), then the subject is to touch the blocks in the same order or backward. The task starting with one block, the blocks per sequence will increase by one if a participant successfully recall a given sequence length twice. Testing will end when the participant makes errors on two successive trials of a given length. Performance will express as the number of sequences successfully recall.
Change in the Stroop test
Time frame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention
This task measures inhibitory control which is one of the core elements of executive functions. The task involves showing words that are the names of colors. The letters making up each word are printed in a color of ink different from the color name the word represents. The participant is asked to quickly respond with the color ink he sees, and inhibit the printed word. Performance will express the time (in seconds) it takes to finish the task and accuracy.
Change in the weekly calendar planning activity test
Time frame: Change from Baseline to 3 months of intervention
This tool was designed to be useful across a variety of populations that exhibit difficulties in executive functioning. It provides a broad analysis of how a person manages and copes with a complex and cognitively challenging activity. In addition to including a weekly schedule, the assessment features client profiles on error analysis, visual performance, awareness of task difficulty, and pre/post comparisons. The Weekly Calendar Planning Activity has three levels of difficulty, from Level 1, the easiest, in which appointments are preordered, to Level 3, the most difficult, in which appointments are randomly ordered in paragraph form. We will use Level 2 for this study, In Level 2 the participant is presented with a list of appointments in random order they have to schedule during 1 week by filling in a paper calendar.
Change in the hazard perception test for pedestrians
Time frame: Change from Baseline to 3 months of intervention
This computerized test was aimed to test and train pedestrians to safe cross walking and detect on road hazards as soon as possible.
Change in brain activity during n-back test
Time frame: Change from Baseline to 3 months of intervention
Functional Magnetic Resonance Imaging (fMRI) is a non-invasive technology. The fMRI paradigm consists of 5 minutes resting-state and an N-back task. We will use the 3.0 Tesla Siemens Prisma MRI Scanner located in Tel-Aviv University.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 32075583Nissim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navah Ratzon, Prof. principal investigator
Tal Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic physical intervention, On-land physical intervention and Non physical intervention in people with Aging and Falling, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Tinetti balance, gait and fall risk test (time frame: Change from Baseline to 1.5 months of intervention and to 3 months of intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03510377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.