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GeriatricsNE-AEinGRNCT06300281

Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics

A study testing Neuromuscular Exercise and Aquatic Exercise in people with Geriatrics and Exercise Therapy, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics. Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2… Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Geriatrics, Exercise Therapy, Fall
What is being tested?
Neuromuscular Exercise and Aquatic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Mar 2024to 30 Oct 2024
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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Being able to speak and understand Turkish,
  • Getting a score at least 21 points on the Montreal Cognitive Assessment Scale (MoCA),
  • Being able to walk without using any assistive device,
  • Being able to adapt to the training program and wanting to participate in the study voluntarily

Who cannot join

  • Presence of neurological, musculoskeletal, inner ear or eye diseases that will cause functional disability and impaired standing balance,
  • Those who have had changes in their medical treatments in the last 6 months,
  • Those with a history of lower extremity surgery as it may affect balance tests,
  • Volunteers who do not attend at least one of the training and evaluations for any reason.
  • Volunteers who want to leave the study voluntarily.
  • Volunteers who cannot continue working due to any additional disease that develops.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Alanya Alaaddin Keykubat University

    Alanya, Antalya, 07100

Other trials in Turkey (Türkiye)

About this study

Objective: The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics.

Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (NE Group) and Group 2 (AE Group) (Randomizer.org). NE (Neuromuscular Exercise) group will participate in a 12-week exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns.AE (Aqıuatic Exercise) Group will participate in an aquatic exercise program, which includes warm-up, mobility and strength, stretching, and cooling exercises in a 140 cm deep pool with a water temperature of 32 °. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire.

Practice Implications: This current study will contribute to the understanding of how neuromuscular exercises affect falls and physical function in geriatrics.

Read the detailed description

Human aging is a complex and individual process that occurs in biological, psychological, and social areas. The metabolic and physicochemical characteristics of cells gradually change with age, a process known as biological aging. This results in cellular self-regulation, regeneration, and structural alterations as well as the degeneration of healthy tissues and organs.

Physical performance impairments are linked to a wide range of negative health consequences, including osteoporosis, falls, and fractures, and are one of the most important health problems in geriatrics. Proprioceptive perception is significantly related to postural stability. Musculoskeletal system disorders (in physiological, neurological, kinesthetic, auditory, vestibular proprioception, and cognitive systems) cause balance problems, which may lead to an increase in the frequency of falls in the elderly. Exercise is critical for healthy aging and may improve walking and balance and reduce the risk of falls in the geriatric population.

Neuromuscular exercise is a relatively broad class of exercise programs that include programs aimed at improving balance, muscle activation, functional alignment, and functional joint stability, known by terms such as functional exercise, proprioceptive, agility, or perturbation training. Unlike traditional strength training, neuromuscular exercise addresses the quality of movement and emphasizes joint control in all three planes. The primary goal of neuromuscular exercise is to achieve compensatory functional stability and improve sensorimotor control. Neuromuscular exercises have been researched in knee osteoarthritis and patellofemoral pain, anterior cruciate ligament injury, fibromyalgia, obesity, autism spectrum disorder in children, cancer, chronic pain, and in various sports fields to improve balance and physical performance after injury.

Aquatic exercises are mostly rehabilitation-oriented practices that can be applied at different temperatures and depths, structured according to a specific goal. In aquatic exercises, the buoyancy of the water reduces the load on the joints, and thanks to the hydrostatic pressure providing support and resistance, older adults can exercise with a lower risk of injury and pain. Studies have shown the positive effects of aquatic exercises on improving dynamic balance, reducing the risk of falling, lower extremity strength, and mental-physical health in geriatrics.

In the literature review on the subject, no study was found comparing neuromuscular exercise and aquatic exercises in the field of geriatrics.

The aim of this study is to compare neuromuscular and aquatic Exercise programs on fall risk and physical function in geriatrics.

Methods:

Participants:

Volunteer individuals who met the inclusion and exclusion criteria and are first and second-year students of Alanya Alaaddin Keykubat University 60+ Renewal University will participate in the study. Detailed information about the study will be given to each participant who wishes to participate in the study, and their written and verbal consent will be obtained.

According to the power analysis made with the G-power program, it was found that 80% power can be obtained with 95% confidence when at least 30 people are included in the study. While calculating the sample size, timed get-up and walk test results [Group 1: 7.81 (standard deviation: 0.91), Group 2: 9.31 (standard deviation: 1.24)] were taken as a basis and the effect size was calculated as = 1.379. The risk of case loss was taken into account by taking a reserve rate of 20%, and it was planned to include 36 participants. The cases will be divided into 2 groups by block randomization using the internet program, consisting of at least 18 individuals: Group 1 [NE group] and Group 2 [AE group] (Randomizer.org).

Study Protocol:

The study will be divided into two parallel groups: The neuromuscular exercise group and the Aquatic exercise group. Both groups will participate in exercise programs for 12 weeks.

Evaluations will be administered before and after exercise programs. Data will be collected using the International Physical Activity Survey Short Form (IPAQ-SF), Montreal Cognitive Assessment Scale (MoCA), Geriatric Pain Measure, Optojump-next (Microgate, Bolzano, Italy), 6-minute Walk Test, 30-second-Sit-to-Stand Test, Four Step Square Test, Berg Balance Scale, Fear of Falling Avoidance Behavior Questionnaire.

Training and Exercise Applications:

A Neuromuscular exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns will be created for the participants in Group 1. Exercises will start with breathing and a 10-minute warm-up period, static and dynamic proprioception, kinesthesia training (weighting on the extremities, balance, walking, open kinetic chain, closed kinetic chain exercises), postural control exercises, Frenkel coordination exercises, balance exercises (balance ball). and with a balance board), muscle strength (calisthenic exercises, therabat exercises), plyometric exercises, and core stabilization exercises will be applied progressively over the weeks and will end with a 10-minute cooling period including flexibility and relaxation exercises.

Participants in Group 2 will undergo an aquatic exercise program at Alanya Alaaddin Keykubat University in a 140 cm deep pool and 32-degree water temperature. The exercise program will begin with a 10-minute warm-up period, including straight, sideways, back walking, cycling without equipment on the parallel bar, lower extremity strength exercises, standing on tiptoes and pressing on the heels, weight transfer, resistant exercises with auxiliary devices, calisthenic exercises, hamstring and quadriceps femoris stretching. It will end with a cooling period including exercises.

Exercise sessions in both groups will last 45-60 minutes and will be applied twice a week for 12 weeks. Blood pressure measurements of all participants will be taken before the exercises. Exercise participation will be tracked in each session.

Statistical Analysis:

In the statistical analysis of data will obtain in this study, a Windows-based SPSS (IBM SPSS Statistics, Version 24.0, Armonk, NY, USA) package program will use. Continuous variables will express as a mean ± standard deviation or as a median (minimum-maximum values), and categorical variables as a number and percent. Analytical (Kolmogorov-Smirnov/Shapiro-Wilks test) and visual (Histogram and probability graphs) methods will use to test the conformity of data for normal distribution. When the parametric test assumptions were provided, Independent Sample T-Test will use to compare independent group differences; when the parametric test assumptions were not provided, the Mann Whitney-U test will use to compare independent group differences. In the dependent group analyses; when the parametric test assumptions were provided, Paired Sample T-Test will use; when the parametric test assumptions were not provided, Wilcoxon Test will use. Chi-Square Analysis and Fisher Exact Test will use compare differences between categorical variables.

Being tested
Neuromuscular Exercise, Aquatic Exercise
Keywords
Geriatrics, Exercise Therapy, Fall, Physical Functional Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular ExerciseBehavioural

    A Neuromuscular exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization

  • Aquatic ExerciseBehavioural

    Also called Aquatherapy, Aquatic Rehabilitation

    The exercise program will begin with a 10-minute warm-up period, including straight, sideways, back walking, cycling without equipment on the parallel bar, lower extremity strength exercises, standing on tiptoes and pressing on the heels, weight transfer, resistant exercises with auxiliary devices, calisthenic exercises, hamstring and quadriceps femoris stretching. It will end with a cooling period including exercises.

Study groups in NCT06300281
Study groupRoleWhat they receive
Neuromuscular Exercise GroupExperimentalA 12-week Neuromuscular exercise program consisting of sensorimotor system training, postural stability and control, global and local joint stabilization, balance training, muscle strength, breathing, and functional movement patterns will be created for the participants in Group 1.
Receives: Behavioral: Neuromuscular Exercise
Aquatic Exercise GroupExperimentalGroup 2 will undergo a 12-week aquatic exercise program at Alanya Alaaddin Keykubat University in a 140 cm deep pool and 32-degree water temperature.
Receives: Behavioral: Aquatic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain

    Change in Pain will be evaluated using Geriatric Pain Measure.Geriatric Pain Scale consists of 24 items. Scores range from 0-100, scores less than 0-30 indicate mild pain; Moderate pain between 30-69 points; A score of 70 points and above is considered severe pain.

    Measured: Before exercise programs and immediately after 12 weeks.

  2. Change in walking and reaction time

    Change in walking and reaction time will be evaluated using Optojump-next (Microgate, Bolzano, Italy)

    Measured: Before exercise programs and immediately after 12 weeks.

  3. Change in aerobic capacity

    Change in aerobic capacity will be evaluated using 6-minute Walk Test

    Measured: Before exercise programs and immediately after 12 weeks.

  4. Change in muscular fitness

    Change in muscular fitness will be evaluated using 30-second-Sit-to-Stand Test

    Measured: Before exercise programs and immediately after 12 weeks.

  5. Change in s balance

    Change in static balance will be evaluated using Berg Balance Scale

    Measured: Before exercise programs and immediately after 12 weeks.

  6. Change in dynamic balance

    Change in static and dynamic balance will be evaluated using Four Step Square Test

    Measured: Before exercise programs and immediately after 12 weeks.

  7. Change in fear of falling

    Change in fear of falling will be evaluated using Fear of Falling Avoidance Behavior Questionnaire. The scale consists of thirty items and ten sub-dimensions. Sub-scores and the total score are calculated by dividing the given score by the number of items on the scale scored according to a 4-point Likert scoring. A high score indicates a high risk of falling.

    Measured: Before exercise programs and immediately after 12 weeks.

Secondary outcomes (2)
  1. Physical activity level

    Physical activity level will be evaluated using International Physical Activity Survey Short Form (IPAQ-SF). As a result of the test, metabolic equivalent (met) is calculated. High met indicates high physical activity.

    Measured: before 12-week exercise programs

  2. Level of cognition

    Level of cognition will be evaluated using Montreal Cognitive Assessment Scale (MoCA). Scale scores range from 0-30. A score of 21 points and above indicates a normal level of cognition.

    Measured: before 12-week exercise programs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study start4 Mar 2024
  3. Primary completion30 Jun 2024
  4. Study completion30 Oct 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be divided into two parallel groups: The neuromuscular exercise group and the Aquatic exercise group. Both groups will participate in exercise programs for 12 weeks.
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06300281
Sponsor's protocol ID
NEAEGeriatircs
Acronym
NE-AEinGR
Status last verified
Jan 2025
First submitted
26 Feb 2024
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Silva NC, Silva MC, Guimaraes MG, Nascimento MBO, Felicio LR. Effects of neuromuscular training and strengthening of trunk and lower limbs muscles in women with Patellofemoral Pain: A protocol of randomized controlled clinical trial, blinded. Trials. 2019 Oct 11;20(1):586. doi: 10.1186/s13063-019-3650-7.

    PubMed 31604478
  • Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev. 2015 Jan;43(1):14-22. doi: 10.1249/JES.0000000000000030.

    PubMed 25390299
  • Shariat A, Ghayour Najafabadi M, Ghannadi S, Nakhostin-Ansari A, Hakakzadeh A, Shaw BS, Ingle L, Cleland JA. Effects of aquatic therapy on balance in older adults: a systematic review and meta-analysis. Eur Geriatr Med. 2022 Apr;13(2):381-393. doi: 10.1007/s41999-021-00577-2. Epub 2021 Nov 24.

    PubMed 34817841
  • Dziechciaz M, Filip R. Biological psychological and social determinants of old age: bio-psycho-social aspects of human aging. Ann Agric Environ Med. 2014;21(4):835-8. doi: 10.5604/12321966.1129943.

    PubMed 25528930
  • Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.

    PubMed 28003033
  • Lee A, Lee KW, Khang P. Preventing falls in the geriatric population. Perm J. 2013 Fall;17(4):37-9. doi: 10.7812/TPP/12-119. No abstract available.

    PubMed 24361019
  • Scarneo SE, Root HJ, Martinez JC, Denegar C, Casa DJ, Mazerolle SM, Dann CL, Aerni GA, DiStefano LJ. Landing Technique Improvements After an Aquatic-Based Neuromuscular Training Program in Physically Active Women. J Sport Rehabil. 2017 Jan;26(1):8-14. doi: 10.1123/jsr.2015-0052. Epub 2016 Aug 24.

    PubMed 27632861

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Exercise and Aquatic Exercise in people with Geriatrics and Exercise Therapy, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).

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 4 inclusion and 6 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 29 Jan 2025. 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 Turkey (Türkiye). 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 Pain (time frame: Before exercise programs and immediately after 12 weeks.). 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 NCT06300281, which also lists 7 linked publications.

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 29 Jan 2025.

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