Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143592
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-16
Brief Title:
Inspiratory Muscle Training on Balance Falls and Diaphragm Thickness in the Elderly
Sponsor:
Gazi University
Organization:
Gazi University
Study Overview
Official Title:
The Effect of Inspiratory Muscle Training on Balance Falls and Diaphragm Thickness in the Elderly A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
Decreases in body muscle mass function and strength occur with ageing and this condition is called sarcopenia It is known that sarcopenic elderly people fall more than non-sarcopenic elderly people their balance is negatively affected their diaphragm thickness decreases and their quality of life may decrease due to their lower functional capacity Although exercise training which is considered among the approaches in the treatment of sarcopenia has been shown to be an effective method the effects of inspiratory muscle training applied at different intensities are relatively limited Therefore in this study we are investigating the effects of low 30 of maximal inspiratory pressure MIP and moderate 50 of MIP inspiratory muscle training on respiratory and peripheral muscle strength physical performance functional capacity balance fear of falling quality of life diaphragm thickness and stiffness in sarcopenic elderly In this study participants are randomly divided into 3 groups a low-intensity inspiratory muscle training group a moderate-intensity inspiratory muscle training group and control sham group by simple random method after being evaluated for respiratory and peripheral muscle strength physical performance functional capacity balance fear of falling quality of life diaphragm thickness and stiffness
Detailed Description:
INTRODUCTION
The proportion of the elderly population compared to the total population is increasing worldwide While this rate was 83 in 2015 it is predicted to reach 178 by 2060 Decreases in body muscle mass function and strength occur with ageing and this condition is called sarcopenia The European Working Group on Sarcopenia in Older People EWGSOP defined sarcopenia as a syndrome characterized by a loss not only in muscle mass but also in muscle strength or physical performance leading to movement disorders hospitalization and falls In studies it was found that the frequency of falls in sarcopenic participants was higher than in non-sarcopenic participants In addition it has been shown that sarcopenia negatively affects balance in the elderly sarcopenic participants have shorter standing times on one leg compared to non-sarcopenic participants their diaphragm thickness decreases and their quality of life decreases due to their lower functional capacity
In order to make a diagnosis of sarcopenia the current situation of the participant should be analyzed in terms of muscle mass muscle strength and physical performance Methods such as Magnetic Resonance Dual Energy X-ray Absorptiometry DEXA Computed Tomography Bioimpedance Analysis BIA and circumference measurement are preferred in the evaluation of muscle mass dynamometer is preferred in the evaluation of muscle strength and tests such as walking speed timed get up and go test sit up and stand test from a chair are preferred in the evaluation of physical performance Important approaches in the prevention and treatment of sarcopenia are exercise physical activity and nutritional support Exercise training in the treatment of sarcopenia has been shown to be an effective method to increase muscle mass and strength in the elderly Both aerobic and resistance exercises have been shown to decrease the rate of decline in muscle mass and increase endurance with age The literature shows that studies have focused especially on exercises involving peripheral muscles However sarcopenia may affect respiratory muscles in addition to peripheral muscles
Respiratory muscle training is a specific exercise training applied to respiratory muscles using skeletal muscle training principles in order to increase respiratory muscle strength and endurance correct the length-tension relationship of respiratory muscles and increase respiratory capacity The most common approach to respiratory muscle training is the inspiratory threshold pressure loading method In the only study in the literature to our knowledge that examined the effect of inspiratory muscle training in sarcopenic elderly the authors compared the effect of peripheral and respiratory exercises on isometric knee extension and arm flexion strength hand grip strength inspiratory and expiratory muscle strength and walking speed but did not examine the effect of training on functional capacity balance fear of falling quality of life diaphragm thickness and stiffness
Studies on inspiratory muscle training in elderly participants have shown an increase in functional capacity and exercise capacity improvement in inspiratory muscle strength and expiratory muscle strength improvement in balance and physical performance increase in diaphragm thickness improvement in lower extremity muscle strength and improvement in quality of life however in the systematic review published in 2020 on inspiratory muscle training in the elderly it was emphasized that the intensity of training maximal inspiratory pressure-MIP varies between 30 and 80 and there is no consensus in the literature on loading The effect of inspiratory muscle training at different intensities in a healthy elderly population was investigated for the first time by Martin-Sanchez et al 2020 who emphasized the effectiveness of exercise performed at 20 and 40 of MIP However since there is no study to our knowledge on inspiratory muscle training applied at different intensities in sarcopenic elderly our study will investigate the effects of low 30 of MIP and moderate 50 of MIP intensity inspiratory muscle training on respiratory and peripheral muscle strength physical performance functional capacity balance fear of falling quality of life diaphragm thickness and stiffness in sarcopenic elderly
METHODS
Design
Participants aged 65 years and over diagnosed with sarcopenia by the relevant physician in Gazi University Faculty of Medicine Department of Internal Medicine Geriatrics Division Outpatient Clinic are included In this randomized controlled single-blind study the participants are randomly divided into 3 groups low-intensity inspiratory muscle training group moderate-intensity inspiratory muscle training group and control sham group by simple random method after being evaluated The evaluations are performed face to face at Gazi University Faculty of Medicine Department of Internal Medicine Division of Geriatrics Except for respiratory muscle strength assessment participants in the treatment group will be evaluated at baseline and at the 12th week after treatment participants in the control group will be evaluated at baseline and at the end of the 12th week respiratory muscle strength will be evaluated at baseline at week 4 at week 8 and at week 12 in all groups The Ethics Committee of Gazi University provided ethical approval 2022-1912122022 All participants included in the study will read and sign the written informed consent form prior to evaluation according to the principles of the Declaration of Helsinki The rights of the participants are fully protected during the study procedures
Sample Size
In line with a similar study in the literature using Gpower software version 31 Universitat Düsseldorf Germany the number of participants required to reach a power level of 080 at 5 type 1 error level with an effect size of 060 was determined as 30 participants
Randomization and Blinding
Before enrolment in the study patients are randomly assigned to 3 groups according to an online randomization table httpswwwrandomorg 2023-03-27 111608 UTC The randomization program is computer-generated using a basic random number generator in blocks Participants are blinded to the intervention groups that they are assigned to
Statistical Analysis
IBM SPSS Statistics 25 Statistical Package for the Social Sciences analysis program will be used for statistical analysis Descriptive analyses will be calculated with minimum-maximum meanstandard deviation XSD and median interquartile range-IQR for numerical data For categorical data number n and percentage values will be defined The suitability of the data obtained from participants to normal distribution will be evaluated by Skewness Kurtosis Histogram Analysis Kolmogorov-Smirnov Test and coefficient of variation ratio The difference between the change in measurement values of participants according to the intervention programs will be calculated by ANOVA one-way analysis of variance if the data fits the normal distribution and by Kruskal Wallis-H Test if the data does not fit the normal distribution Post-hoc tests will be applied to investigate the differences between the groups
The proportion of the elderly population compared to the total population is increasing worldwide While this rate was 83 in 2015 it is predicted to reach 178 by 2060 Decreases in body muscle mass function and strength occur with ageing and this condition is called sarcopenia The European Working Group on Sarcopenia in Older People EWGSOP defined sarcopenia as a syndrome characterized by a loss not only in muscle mass but also in muscle strength or physical performance leading to movement disorders hospitalization and falls In studies it was found that the frequency of falls in sarcopenic participants was higher than in non-sarcopenic participants In addition it has been shown that sarcopenia negatively affects balance in the elderly sarcopenic participants have shorter standing times on one leg compared to non-sarcopenic participants their diaphragm thickness decreases and their quality of life decreases due to their lower functional capacity
In order to make a diagnosis of sarcopenia the current situation of the participant should be analyzed in terms of muscle mass muscle strength and physical performance Methods such as Magnetic Resonance Dual Energy X-ray Absorptiometry DEXA Computed Tomography Bioimpedance Analysis BIA and circumference measurement are preferred in the evaluation of muscle mass dynamometer is preferred in the evaluation of muscle strength and tests such as walking speed timed get up and go test sit up and stand test from a chair are preferred in the evaluation of physical performance Important approaches in the prevention and treatment of sarcopenia are exercise physical activity and nutritional support Exercise training in the treatment of sarcopenia has been shown to be an effective method to increase muscle mass and strength in the elderly Both aerobic and resistance exercises have been shown to decrease the rate of decline in muscle mass and increase endurance with age The literature shows that studies have focused especially on exercises involving peripheral muscles However sarcopenia may affect respiratory muscles in addition to peripheral muscles
Respiratory muscle training is a specific exercise training applied to respiratory muscles using skeletal muscle training principles in order to increase respiratory muscle strength and endurance correct the length-tension relationship of respiratory muscles and increase respiratory capacity The most common approach to respiratory muscle training is the inspiratory threshold pressure loading method In the only study in the literature to our knowledge that examined the effect of inspiratory muscle training in sarcopenic elderly the authors compared the effect of peripheral and respiratory exercises on isometric knee extension and arm flexion strength hand grip strength inspiratory and expiratory muscle strength and walking speed but did not examine the effect of training on functional capacity balance fear of falling quality of life diaphragm thickness and stiffness
Studies on inspiratory muscle training in elderly participants have shown an increase in functional capacity and exercise capacity improvement in inspiratory muscle strength and expiratory muscle strength improvement in balance and physical performance increase in diaphragm thickness improvement in lower extremity muscle strength and improvement in quality of life however in the systematic review published in 2020 on inspiratory muscle training in the elderly it was emphasized that the intensity of training maximal inspiratory pressure-MIP varies between 30 and 80 and there is no consensus in the literature on loading The effect of inspiratory muscle training at different intensities in a healthy elderly population was investigated for the first time by Martin-Sanchez et al 2020 who emphasized the effectiveness of exercise performed at 20 and 40 of MIP However since there is no study to our knowledge on inspiratory muscle training applied at different intensities in sarcopenic elderly our study will investigate the effects of low 30 of MIP and moderate 50 of MIP intensity inspiratory muscle training on respiratory and peripheral muscle strength physical performance functional capacity balance fear of falling quality of life diaphragm thickness and stiffness in sarcopenic elderly
METHODS
Design
Participants aged 65 years and over diagnosed with sarcopenia by the relevant physician in Gazi University Faculty of Medicine Department of Internal Medicine Geriatrics Division Outpatient Clinic are included In this randomized controlled single-blind study the participants are randomly divided into 3 groups low-intensity inspiratory muscle training group moderate-intensity inspiratory muscle training group and control sham group by simple random method after being evaluated The evaluations are performed face to face at Gazi University Faculty of Medicine Department of Internal Medicine Division of Geriatrics Except for respiratory muscle strength assessment participants in the treatment group will be evaluated at baseline and at the 12th week after treatment participants in the control group will be evaluated at baseline and at the end of the 12th week respiratory muscle strength will be evaluated at baseline at week 4 at week 8 and at week 12 in all groups The Ethics Committee of Gazi University provided ethical approval 2022-1912122022 All participants included in the study will read and sign the written informed consent form prior to evaluation according to the principles of the Declaration of Helsinki The rights of the participants are fully protected during the study procedures
Sample Size
In line with a similar study in the literature using Gpower software version 31 Universitat Düsseldorf Germany the number of participants required to reach a power level of 080 at 5 type 1 error level with an effect size of 060 was determined as 30 participants
Randomization and Blinding
Before enrolment in the study patients are randomly assigned to 3 groups according to an online randomization table httpswwwrandomorg 2023-03-27 111608 UTC The randomization program is computer-generated using a basic random number generator in blocks Participants are blinded to the intervention groups that they are assigned to
Statistical Analysis
IBM SPSS Statistics 25 Statistical Package for the Social Sciences analysis program will be used for statistical analysis Descriptive analyses will be calculated with minimum-maximum meanstandard deviation XSD and median interquartile range-IQR for numerical data For categorical data number n and percentage values will be defined The suitability of the data obtained from participants to normal distribution will be evaluated by Skewness Kurtosis Histogram Analysis Kolmogorov-Smirnov Test and coefficient of variation ratio The difference between the change in measurement values of participants according to the intervention programs will be calculated by ANOVA one-way analysis of variance if the data fits the normal distribution and by Kruskal Wallis-H Test if the data does not fit the normal distribution Post-hoc tests will be applied to investigate the differences between the groups
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