Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294002
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-20
Brief Title:
Neuromuscular Training Postural Stability
Sponsor:
University of Novi Sad
Organization:
University of Novi Sad
Study Overview
Official Title:
Effect of Different Neuromuscular Training Modalities on Postural Stability in Healthy Recreation People A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STABLEFIT
Brief Summary:
Background Postural stability PS is a vital function that helps maintain equilibrium during standing still locomotion and any activities requiring high balance performance Under static and dynamic conditions PS is a fundamental factor for the quality of movement in everyday activities or sports PS and adaptive ability are required in sports due to the interactions between the sensory and motor systems which regulate postural adjustments by processing information from the visual vestibular and somatosensory systems as reported by previous studies The interest in using different exercises and protocols for improving PS in sports and physiotherapy has grown in the last few decades Experts have proposed various training modalities to increase neuromuscular stability balance postural control and general stability Dynamic Neuromuscular Stabilization DNS is a complex of correction exercises with a neuromuscular approach based on improving breathing fundamental movements and principles of developmental kinesiology Whole body vibration training WBV is a neuromuscular training approach that has recently become very popular among researchers and practitioners in health and sport It is usually used as an additional method in a conventional training routine Designing the training program to achieve the optimal benefits for PS in healthy young adults is important in general personal health management Although different training protocols have improved PS and general stability in everyday activities there is still considerable debate regarding the optimal exercise modalities within an exercise program Aim The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation DNS whole-body vibration WBV and a combination of DNS and WBV MIX training modalities on postural stability PS in healthy recreation participants Method and materials 180 gender-balanced groups were divided into four groups MIX DNS VIBRO and CONTROL and underwent two months of treatment The single and double-leg Center of Force COF parameters were collected on the Forceplate
Detailed Description:
Study design The purpose of this study is to determine the effects of dynamic neuromuscular stabilisation DNS whole-body vibration WBV and a combination of DNS and WBV MIX training modalities on postural stability PS in healthy recreation participants The study presents an Interventional study to improve postural stability and the main objective is prevention The study model is parallel with four groups
Participants The randomised controlled interventional trial enrolled a gender-balanced group of 180 healthy young participants The initial sample of respondents was recruited through an open online application that lasted two months from 1022022 to 1042022 n250 after which the first selection of respondents was started n230 Recruitment was completed after the optimal sample of subjects was filled 1542022 The study sample was divided using stratified randomisation into the MIX group n 58 DNS group n57 VIBRO n57 and CONTROL group n58 At the end of the experimental program the final sample was 180 MIX45 DNS45 VIBRO44 CONTROL43 When stratifying researchers use proportionate sampling to maintain the correct proportions of genders in every group After explaining the experimental protocol each subject provided written informed consent before participating in the study per the Declaration of Helsinki and the Novi Sad University Human Research Ethics Committee guidelines ethical approval number 46-06-042020-1 The interventional program was conducted from 2542022 to 2562022 Ethics committee - commission for the implementation of scientific project research
The exclusion criteria were
history of neurological or musculoskeletal disorders
clinical conditions that could impair balance motor disorders medical conditions like diabetes heart disease stroke issues with vision thyroid nerves or blood vessels
The inclusion criteria for this study were
the absence of injuries in the past six months and the absence of other medical conditions including COVID-19 no programmed physical activity in the past three months
Testing procedures The testing was conducted at the Faculty of Sport and Physical Education University of Novi Sad Serbia All participants were tested in the morning before their training session in indoor environmental conditions temperature 18-21C relative humidity 40-60 Before starting a performance task general information about the examinees was recorded including gender age height and mass Participants were instructed to wear minimal clothing and remove all footwear for height and mass measurements In addition they were required to eat and drink sparingly and void their bladderexcrete as needed before presenting for assessment A stadiometer 01 cm accuracy SECA Instruments Ltd Hamburg Germany is a secondary outcome for height and mass measurements Initial testing was conducted on 2042022 and final on 2562022
Static PS was assessed with a laboratory-grade 05 m Footscan plate RSscan International Lammerdries Belgium with 4096 sensors and a scanning rate of up to 300 Hz The subject performed an individual single and double-leg task with three trials each lasting 30 seconds with a two-minute break between each trial During the double-leg stance test participants were instructed to maintain an upright posture as still as possible They were asked to stand in their natural comfortable position with their eyes open and fixed on a cross positioned at approximately eye level on a blackboard 5 meters away Participants stood barefoot with their feet placed shoulder-width apart on a platform and their arms were kept by their sides Each participant was required to maintain this stable posture and measurement started after 10 seconds preparation period to avoid transient effects During the single-limb stance test participants were instructed to balance on one foot This foot was positioned to point directly forward aligning with reference lines in the frontal and sagittal planes The swinging leg was flexed at the hip and knee joints to approximately 90 degrees while both arms hung naturally and relaxed at their sides Participants were further instructed to maintain as steady a posture as possible focusing their gaze straight ahead on a point situated 65 centimetres away on the wall The order of testing between the left and right legs was randomised Each participant was required to maintain this stable position and measurement started after 5 seconds preparation period to avoid transient effects
Tests for static PS were the gold standard in measuring balance and were used to obtain biomechanical parameters of static PS All measurements were performed in triplicate and the mean score was retained for subsequent evaluations and analyses The sequence of performing the balance tasks was randomised
The software calculated the single and double-leg Sway Area cm² Center of Force COF travelled way mm Medio-Lateral ML displacement mm and Anterior-Posterior AP displacement mm as primary outcomes As stated in previous research the following protocol was chosen based on their varying difficulty and everyday use and is cited as reliable
Interventions Dynamic neuromuscular stabilisation group DNS The DNS groups protocol involved 5 min a moderate-intensity warm-up 40 minutes of DNS movements according to the DNS approach different diaphragmatic breathing mobility and controlled movement exercises and 5 minutes of cool-down Exercises gradually increased in complexity and difficulty level regarding DNS training principles The participants were instructed to refrain from engaging in high-intensity anaerobic or anaerobic resistance training throughout the study period to prevent potential disruptions in the study results
Whole body vibration group VIBRO WBV was performed on the Power Plate Next Generation vibration platform Power Plate North America Chicago IL All training routines were approximately 50 minutes long commencing with 5 minutes of moderate-intensity warm-up and concluding with a cool-down period The program consisted of 8-10 static and dynamic exercises for PS that progressively increased in difficulty and complexity During the training process the frequency increased from 20 to 35 Hz in the last week of the experiment the exercise duration was from 20 - 60 seconds in the previous week followed by 1-minute seated rest Moreover the complexity and difficulty of exercise increased over the experimental period The resting period between sets was constant from the start to the end of the training process During the experiment the WBV intervention group performed three weekly training sessions The participants were advised to avoid participating in high-intensity anaerobic or anaerobic resistance training during the study to ensure that it would not interfere with the studys outcomes-no changes to trial outcomes after the trial commenced Principles and basic procedures were adapted from previous research
Dynamic neuromuscular stabilisation with whole body vibration group MIX During the two months participants in the MIX group performed training consisting of 3 weekly sessions The protocol consisted of a 50-minute exercise program with a 5-minute moderate-intensity warm-up and cool-down period per training session The structural core of training included 20 minutes of WBV and 20 minutes of DNS training Both protocols followed the previous research and training recommendations and were performed with less time and sets Exercises with VIBRO were performed on the Power Plate Next Generation vibration platform Power Plate North America Chicago IL The program consisted of 6-8 exercises static and dynamic for balance and PS Exercise progressively increases by the level of difficulty During the training process the frequency was also increased from 20 to 35 Hz in the last week of the experiment the duration of exercise from 20 - 60 seconds in the previous week followed by 1-minute seated rest The resting period between sets was constant from the start to the end of the training process To prevent any interference with the studys results participants were recommended to abstain from engaging in high-intensity anaerobic or anaerobic resistance training throughout the study Basic principles and procedures were adapted from previous research WBV is followed by 20 minutes of DNS training including specific movement exercises according to the DNS approach accompanied by breathing coordination mobility and stability core exercises and routines suggested in previous studies During the experiment the MIX intervention group performed three training sessions weekly
Control group CONTROL The control group did not exercise or use any training intervention or other habitual training during the past two months During this period the control group maintained their regular daily routines without any modifications They refrained from engaging in any form of physical activity or participating in training programs that could influence their fitness levels
Statistical analyses Gpower 31 power analysis software Heinrich-Heine-University Düsseldorf Germany estimated the minimum total sample size N140 given the critical F3 136267 an effect size f014 partial η2002 p005 1-β080 groups4 time points2 and correlation among the measurements050 The authors presented data as means and 95 confidence intervals 95 CIs The Kolmogorov-Smirnov Levens Boxs and Mauchlys tests confirmed the assumptions of normality homogeneity of variances and covariances and sphericity respectively General linear models twelve separate 2x4 mixed-design analyses of covariances for each PS measure estimated whether mean changes 95 CIs in PS measure from initial to final testing depended on whether participants received the DNS VIBRO and MIX exercise program or did not CONTROL after controlling for mean-centered BMI Following the time-by-group interaction effects which revealed whether estimated changes over time depended on the participants group ie differed at least between one group-comparison pair we computed simple effects tests to estimate mean changes over time mean difference from initial to final testing within the groups The follow-up investigation proceeded with contrast analysis which assessed the degree to which estimated mean changes of PS measures differed between the group-comparison pairs The authors calculated the effect size for time-by-group interaction effects and simple effects using partial eta squared partial η2 001 small 006 medium 014 large and Hedges g average Hedgesav 020 trivial 020 small 050 medium 080 large respectively The Bonferroni test corrected p-values and 95 CI the alpha level was p005 We used SPSS version 230 SPSS Inc Chicago IL USA and GraphPad Prism version 80 GraphPad Software San Diego California USA to analyse and plot the data respectively
Participants The randomised controlled interventional trial enrolled a gender-balanced group of 180 healthy young participants The initial sample of respondents was recruited through an open online application that lasted two months from 1022022 to 1042022 n250 after which the first selection of respondents was started n230 Recruitment was completed after the optimal sample of subjects was filled 1542022 The study sample was divided using stratified randomisation into the MIX group n 58 DNS group n57 VIBRO n57 and CONTROL group n58 At the end of the experimental program the final sample was 180 MIX45 DNS45 VIBRO44 CONTROL43 When stratifying researchers use proportionate sampling to maintain the correct proportions of genders in every group After explaining the experimental protocol each subject provided written informed consent before participating in the study per the Declaration of Helsinki and the Novi Sad University Human Research Ethics Committee guidelines ethical approval number 46-06-042020-1 The interventional program was conducted from 2542022 to 2562022 Ethics committee - commission for the implementation of scientific project research
The exclusion criteria were
history of neurological or musculoskeletal disorders
clinical conditions that could impair balance motor disorders medical conditions like diabetes heart disease stroke issues with vision thyroid nerves or blood vessels
The inclusion criteria for this study were
the absence of injuries in the past six months and the absence of other medical conditions including COVID-19 no programmed physical activity in the past three months
Testing procedures The testing was conducted at the Faculty of Sport and Physical Education University of Novi Sad Serbia All participants were tested in the morning before their training session in indoor environmental conditions temperature 18-21C relative humidity 40-60 Before starting a performance task general information about the examinees was recorded including gender age height and mass Participants were instructed to wear minimal clothing and remove all footwear for height and mass measurements In addition they were required to eat and drink sparingly and void their bladderexcrete as needed before presenting for assessment A stadiometer 01 cm accuracy SECA Instruments Ltd Hamburg Germany is a secondary outcome for height and mass measurements Initial testing was conducted on 2042022 and final on 2562022
Static PS was assessed with a laboratory-grade 05 m Footscan plate RSscan International Lammerdries Belgium with 4096 sensors and a scanning rate of up to 300 Hz The subject performed an individual single and double-leg task with three trials each lasting 30 seconds with a two-minute break between each trial During the double-leg stance test participants were instructed to maintain an upright posture as still as possible They were asked to stand in their natural comfortable position with their eyes open and fixed on a cross positioned at approximately eye level on a blackboard 5 meters away Participants stood barefoot with their feet placed shoulder-width apart on a platform and their arms were kept by their sides Each participant was required to maintain this stable posture and measurement started after 10 seconds preparation period to avoid transient effects During the single-limb stance test participants were instructed to balance on one foot This foot was positioned to point directly forward aligning with reference lines in the frontal and sagittal planes The swinging leg was flexed at the hip and knee joints to approximately 90 degrees while both arms hung naturally and relaxed at their sides Participants were further instructed to maintain as steady a posture as possible focusing their gaze straight ahead on a point situated 65 centimetres away on the wall The order of testing between the left and right legs was randomised Each participant was required to maintain this stable position and measurement started after 5 seconds preparation period to avoid transient effects
Tests for static PS were the gold standard in measuring balance and were used to obtain biomechanical parameters of static PS All measurements were performed in triplicate and the mean score was retained for subsequent evaluations and analyses The sequence of performing the balance tasks was randomised
The software calculated the single and double-leg Sway Area cm² Center of Force COF travelled way mm Medio-Lateral ML displacement mm and Anterior-Posterior AP displacement mm as primary outcomes As stated in previous research the following protocol was chosen based on their varying difficulty and everyday use and is cited as reliable
Interventions Dynamic neuromuscular stabilisation group DNS The DNS groups protocol involved 5 min a moderate-intensity warm-up 40 minutes of DNS movements according to the DNS approach different diaphragmatic breathing mobility and controlled movement exercises and 5 minutes of cool-down Exercises gradually increased in complexity and difficulty level regarding DNS training principles The participants were instructed to refrain from engaging in high-intensity anaerobic or anaerobic resistance training throughout the study period to prevent potential disruptions in the study results
Whole body vibration group VIBRO WBV was performed on the Power Plate Next Generation vibration platform Power Plate North America Chicago IL All training routines were approximately 50 minutes long commencing with 5 minutes of moderate-intensity warm-up and concluding with a cool-down period The program consisted of 8-10 static and dynamic exercises for PS that progressively increased in difficulty and complexity During the training process the frequency increased from 20 to 35 Hz in the last week of the experiment the exercise duration was from 20 - 60 seconds in the previous week followed by 1-minute seated rest Moreover the complexity and difficulty of exercise increased over the experimental period The resting period between sets was constant from the start to the end of the training process During the experiment the WBV intervention group performed three weekly training sessions The participants were advised to avoid participating in high-intensity anaerobic or anaerobic resistance training during the study to ensure that it would not interfere with the studys outcomes-no changes to trial outcomes after the trial commenced Principles and basic procedures were adapted from previous research
Dynamic neuromuscular stabilisation with whole body vibration group MIX During the two months participants in the MIX group performed training consisting of 3 weekly sessions The protocol consisted of a 50-minute exercise program with a 5-minute moderate-intensity warm-up and cool-down period per training session The structural core of training included 20 minutes of WBV and 20 minutes of DNS training Both protocols followed the previous research and training recommendations and were performed with less time and sets Exercises with VIBRO were performed on the Power Plate Next Generation vibration platform Power Plate North America Chicago IL The program consisted of 6-8 exercises static and dynamic for balance and PS Exercise progressively increases by the level of difficulty During the training process the frequency was also increased from 20 to 35 Hz in the last week of the experiment the duration of exercise from 20 - 60 seconds in the previous week followed by 1-minute seated rest The resting period between sets was constant from the start to the end of the training process To prevent any interference with the studys results participants were recommended to abstain from engaging in high-intensity anaerobic or anaerobic resistance training throughout the study Basic principles and procedures were adapted from previous research WBV is followed by 20 minutes of DNS training including specific movement exercises according to the DNS approach accompanied by breathing coordination mobility and stability core exercises and routines suggested in previous studies During the experiment the MIX intervention group performed three training sessions weekly
Control group CONTROL The control group did not exercise or use any training intervention or other habitual training during the past two months During this period the control group maintained their regular daily routines without any modifications They refrained from engaging in any form of physical activity or participating in training programs that could influence their fitness levels
Statistical analyses Gpower 31 power analysis software Heinrich-Heine-University Düsseldorf Germany estimated the minimum total sample size N140 given the critical F3 136267 an effect size f014 partial η2002 p005 1-β080 groups4 time points2 and correlation among the measurements050 The authors presented data as means and 95 confidence intervals 95 CIs The Kolmogorov-Smirnov Levens Boxs and Mauchlys tests confirmed the assumptions of normality homogeneity of variances and covariances and sphericity respectively General linear models twelve separate 2x4 mixed-design analyses of covariances for each PS measure estimated whether mean changes 95 CIs in PS measure from initial to final testing depended on whether participants received the DNS VIBRO and MIX exercise program or did not CONTROL after controlling for mean-centered BMI Following the time-by-group interaction effects which revealed whether estimated changes over time depended on the participants group ie differed at least between one group-comparison pair we computed simple effects tests to estimate mean changes over time mean difference from initial to final testing within the groups The follow-up investigation proceeded with contrast analysis which assessed the degree to which estimated mean changes of PS measures differed between the group-comparison pairs The authors calculated the effect size for time-by-group interaction effects and simple effects using partial eta squared partial η2 001 small 006 medium 014 large and Hedges g average Hedgesav 020 trivial 020 small 050 medium 080 large respectively The Bonferroni test corrected p-values and 95 CI the alpha level was p005 We used SPSS version 230 SPSS Inc Chicago IL USA and GraphPad Prism version 80 GraphPad Software San Diego California USA to analyse and plot the data respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None