NCT06300281

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

February 26, 2024

Last Update Submit

January 27, 2025

Conditions

Keywords

GeriatricsExercise TherapyFallPhysical Functional Performance

Outcome Measures

Primary Outcomes (7)

  • 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.

    Before exercise programs and immediately after 12 weeks.

  • Change in walking and reaction time

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

    Before exercise programs and immediately after 12 weeks.

  • Change in aerobic capacity

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

    Before exercise programs and immediately after 12 weeks.

  • Change in muscular fitness

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

    Before exercise programs and immediately after 12 weeks.

  • Change in s balance

    Change in static balance will be evaluated using Berg Balance Scale

    Before exercise programs and immediately after 12 weeks.

  • Change in dynamic balance

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

    Before exercise programs and immediately after 12 weeks.

  • 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.

    Before exercise programs and immediately after 12 weeks.

Secondary Outcomes (2)

  • Physical activity level

    before 12-week exercise programs

  • Level of cognition

    before 12-week exercise programs

Study Arms (2)

Neuromuscular Exercise Group

EXPERIMENTAL

A 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.

Behavioral: Neuromuscular Exercise

Aquatic Exercise Group

EXPERIMENTAL

Group 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.

Behavioral: Aquatic Exercise

Interventions

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

Neuromuscular Exercise Group

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.

Also known as: Aquatherapy, Aquatic Rehabilitation
Aquatic Exercise Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University

Alanya, Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 31604478BACKGROUND
  • 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.

    PMID: 25390299BACKGROUND
  • 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.

    PMID: 34817841BACKGROUND
  • 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.

    PMID: 25528930BACKGROUND
  • 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.

    PMID: 28003033BACKGROUND
  • 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.

    PMID: 24361019BACKGROUND
  • 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.

    PMID: 27632861BACKGROUND

MeSH Terms

Interventions

Muscle Stretching ExercisesAquatic Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHydrotherapy

Study Officials

  • Özüm ÇETİNKAYA, PT, MSc

    Alanya Alaaddin Keykubat University

    PRINCIPAL INVESTIGATOR
  • Ummuhan BAŞ ASLAN, Prof.Dr.PT.

    Pamukkale University

    STUDY DIRECTOR
  • Özgür NALBANT, Asst.Prof.Dr

    Alanya Alaaddin Keykubat Univercity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSC. ,Principal Investigator

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 8, 2024

Study Start

March 4, 2024

Primary Completion

June 30, 2024

Study Completion

October 30, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations