Effects of Aquatic Intervention on Fall Risk, Hazard Perception, Calendar Planning and Brain Activity During Elderly

NCT03510377 | Completed

• 1 other identifier: Michal Nissim
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Falling; Pedestrian Accidents; Physical Activity

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Change from Baseline to 3 months of intervention

Study Arms (3)

Aquatic physical intervention

EXPERIMENTAL

Aquatic physical intervention: Ai-Chi

Other: Aquatic physical intervention; Other: On-land physical intervention; Other: Non physical intervention

On-land physical intervention

EXPERIMENTAL

On-land physical intervention: Tai-Chi

Other: Aquatic physical intervention; Other: On-land physical intervention; Other: Non physical intervention

Non physical intervention

EXPERIMENTAL

Non physical intervention: Guided imagery

Other: Aquatic physical intervention; Other: On-land physical intervention; Other: Non physical intervention

Interventions

Aquatic physical intervention OTHER

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).

Aquatic physical intervention; Non physical intervention; On-land physical intervention

On-land physical intervention OTHER

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.

Aquatic physical intervention; Non physical intervention; On-land physical intervention

Non physical intervention OTHER

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.

Aquatic physical intervention; Non physical intervention; On-land physical intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Aviv University: lead
• The Science, Technology and Space Ministry, Israel: collaborator

Study Sites (1)

Sackler Faculty of Medicine

Tel Aviv, Israel

Location

Related Publications (1)

• 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.

  PMID: 32075583 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Navah Ratzon, Prof.

  Tal Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Occupational Therapist

Model Details: Volunteers that will meet the inclusion criteria will be randomly divided to three intervention groups.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: April 27, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

IL (1)