Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06300281
Study type Interventional
Source Alanya Alaaddin Keykubat University
Contact Özüm ÇETINKAYA, PT, MSc
Phone +905068794804
Email ozum.eren@alanya.edu.tr
Status Not yet recruiting
Phase N/A
Start date May 4, 2024
Completion date October 30, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04612842 - Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT06063187 - Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Withdrawn NCT04470895 - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting NCT05940779 - Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial. N/A
Not yet recruiting NCT05991037 - Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People N/A
Not yet recruiting NCT05940636 - A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity N/A
Completed NCT03566719 - Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults N/A
Not yet recruiting NCT05702801 - Vibratory Stimulation to Improve Balance Recovery N/A
Not yet recruiting NCT04439097 - Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease N/A
Recruiting NCT04108741 - Augmented Reality Treadmill Training in Patients With Parkinson's Disease N/A
Completed NCT04760392 - Goal-directed Mobilization of Medical Inpatients N/A
Not yet recruiting NCT03680014 - Remote Monitoring and Analysis of Gait and Falls Within an Elderly Population
Recruiting NCT04851405 - Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago) N/A
Completed NCT05090774 - Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study N/A
Completed NCT04334746 - The Discriminative Ability of the Four Balance Measures for Fall History
Completed NCT03341728 - The Sensorimotor Locus of Balance Control in Elderly Gait N/A
Completed NCT05290571 - Modified Otago Exercise Program on Balance Performance N/A
Completed NCT04622657 - Validity Reliability of The Dubousset Functional Test in Parkinson Disease N/A
Completed NCT05863143 - Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor N/A