DynapeniaNCT06621875
Effect Of The Presence Of Dynapenia On Posture, Spine Muscle Elasticity, Strength And Endurance In Young Adults
An observational study of Dynapenia and Muscle Weakness, run by Aynur Ayazzade.
Trial summary
The aim of the present study was to determine the effect of dynapenia on posture, spinal muscle elasticity, strength and endurance in young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dynapenia, Muscle Weakness, Sarcopenia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Oct 2025
- Phase
- Observational
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants between the ages of 18-25 who agreed to participate in the study
Who may be able to join
- Being between the ages of 18-25
- Filling out all the survey questions
Who cannot join
- Presence of chronic diseases that may affect the musculoskeletal system (diabetes, heart disease, neurological disorders)
- Use of medications that may affect muscle functions (corticosteroids, muscle relaxants)
- Presence of serious musculoskeletal injury within the last six months
- Presence of surgery and/or pain related to the musculoskeletal system
- History of eating disorders such as anorexia nervosa, bulimia nervosa were defined as exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the present study was to determine the effect of dynapenia on posture, spinal muscle elasticity, strength and endurance in young adults.
Read the detailed description
Skeletal muscle plays an important role in general health and physical development throughout the life cycle [1]. Skeletal muscle strength and performance are of critical importance in performing daily activities, maintaining mobility, and maintaining general health. Therefore, changes in general muscle strength and performance due to various reasons differentiate muscle contraction quality and neural activation, facilitating for the concept of 'dynapenia' [2,3].
Dynapenia is defined as a decrease in performance and/or strength without loss of muscle mass [4]. Although dynapenia, which facilitates for morbidity and mortality [5,7], is a well-defined condition in the elderly, there is very limited information about its prevalence and causes in young people [8]. Dynapenia, which has many negative effects on quality of life and daily functioning for the general population [9], is considered a form of accelerated muscle aging and can be defined as the "pre-sarcopenia stage" [10].
When other causes of dynapenia are examined in the literature; age and chronic diseases have been emphasized, but it has been overlooked that one of the most important modifiable factors, inadequate physical activity, can facilitate for dynapenia, especially in young people [4]. The COVID-19 pandemic that started in 2020 and the quarantine and similar measures taken subsequently have led to a decrease in physical activity levels in young people and an increase of approximately 28% in daily sitting time [11]. Low physical activity levels and the resulting decrease in muscle strength and performance can facilitate for dynapenia in young individuals [4,12].
Individuals who spend a long time in front of the computer also struggle with many health problems caused by being inactive for a long time, especially in the neck and waist [13,14]. Posture that is disrupted by the side effects of sitting for a long time can cause a decrease in muscle length and/or elasticity in certain groups of muscles [15]. Changes in the muscle also lead to a decrease in muscle strength over time [16,17], which can be an accelerating factor for dynapenia.
In the literature, many studies have addressed postural disorders, spinal muscle elasticity, muscle strength and endurance with the functional strength parameter handgrip strength [18,21], but no study has examined these parameters in young individuals with dynapenia. When deciding on the presence of dynapenia, handgrip strength is the most important parameter that provides information about general muscle strength. However, changes in the spine in individuals with dynapenia, whose handgrip strength and general muscle performance are reduced, have been ignored in the literature.
Evaluating posture, spinal muscle strength, elasticity and endurance in individuals with dynapenia can be a fundamental step in preparing preventive and therapeutic algorithms against dynapenia. The strength and endurance of spinal muscles can play a critical role in providing postural control, preserving movement functions and reducing the risk of injury, especially in individuals with dynapenia. Therefore, examining factors related to the spine in the presence of dynapenia in young individuals can make significant contributions to developing preventive health strategies, increasing functional capacities and improving quality of life.
According to above information; The aim of the present study was to determine the effect of dynapenia on posture, spinal muscle elasticity, strength and endurance in young adults.
Data collection will be carried out as follows: Participants' height, weight, body mass index and smoking, average time spent in front of the screen during the day (hours of daily use x years of use), presence of Covid-19, number of cases and when it occurred will be recorded verbally. Physical activity level will be assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-SF) [22,23]; average smartphone usage time with the Smartphone Addiction Scale Short Form [24], and sleep quality (Pittsburgh Sleep Quality Index) [25]. Those with no decrease in muscle mass but a decrease in muscle strength and/or performance will be included in the 'dypenia group', and those with no decrease in muscle mass, muscle function and performance will be included in the 'control group'.
- Conditions
- Dynapenia, Muscle Weakness, Sarcopenia
- Keywords
- Muscle strength, Sarcopenia, Posture, Muscle elasticity, Muscle endurance, Dynapenia, Hand Grip
- Medical subject headings
- Muscle Weakness, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dynapenia Group | Those with no decrease in muscle mass but decreased muscle strength and/or performance will be included in the 'dynapenia group'. | |
| Control Group | Those with no decrease in muscle mass, muscle function and performance will be included in the 'control group'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioelectrical Impedance Analysis
Bioelectrical impedance analysis is a method used to evaluate body composition [30]. Impedance refers to the resistance of tissue to electric current and is inversely proportional to conductivity. For example, components with high specific resistance such as bone and fat tissue make it difficult for electric current to pass, while components with low resistance such as skeletal muscle and visceral organs can easily conduct electric current. This principle forms the basis of bioelectrical impedance analysis [31,32]. Values of < 8.87 kg/m2 in men and < 6.42 kg/m2 in women were considered low muscle mass [9].
The Tanita BC 401 device will be used in the current study. Participants will be informed before the BIA measurement and will be asked not to drink alcohol for up to 48 hours, not to eat or drink 4 hours before, not to consume tea, coffee and cola for 12 hours before, and not to exercise. In addition, women's measurements will be taken outside of the menstrual period [33,34].
Measured: two months
Assessment of Muscle Strength
Grip strength, will be measured using the JAMAR hand dynamometer and standardized protocol [37]. The JAMAR hand dynamometer is a reliable and most widely used measurement tool for measuring static grip strength [35,38]. Measurements are based on the principle of compressing two parallel bars. The participant is given a position suitable for holding and grip strength and the evaluation is made [38,41]. The needle of the JAMAR Hand Dynamometer can measure up to 90 kg [37,39,42]. The person should sit on a seat without arm support, with the arm in adduction and neutral rotation, the elbow in 90-degree flexion and the forearm in a neutral position [43,44]. The average of three trials for each hand was used to determine general grip strength. Inadequacy in hand grip strength was determined as less than 20 kg for women and less than 30 kg for men [45].
Measured: two months
Assessment of Muscle Performance: 4-Meter Walk Test(4-MWT)
4-Meter Walk Test(4-MWT): (4-MWT) is a walking speed test that evaluates functional limitations and physical performance. (4-MWT) is a widely used test due to its simplicity and high test-retest reliability [46]. Test walking speed is the most commonly used and practical method for evaluating muscle performance in the clinic. A normal value is approximately 3.57 seconds. Additionally, walking speeds of less than 0.8 m/s have been associated with a risk of falling [46,49].
Measured: two months
Assessment of Muscle Performance: Sit-to-Stand Test(SST)
Sit-to-Stand Test(SST): The participant is asked to stand up and sit down completely from a chair for one minute with the arms crossed at chest height from a standard chair height of 45 cm. The number of times the person stands up and sits down completely constitutes the total score [50]. During the test, the participant is seated upright on a chair with their feet touching the floor. The person's arms are crossed in front of their chest. The test is started with the command and the number of times the person gets up completely within 30 seconds is recorded. Only a chair and a stopwatch are required for the test. In the evaluations made for young adults, while for men, results below 15 repetitions in the 30-second sit-to-stand test can be considered as poor performance, this limit is determined as 12 repetitions for women [51].
Measured: two months
Secondary outcomes (7)
Assessment of Posture Angles
The camera, which is placed perpendicular to the floor with a tripod, will be placed 80 cm away from the participant, at the level of the participant's shoulders. The participant is asked to focus on a point at eye level. After taking a lateral photo of the participants while standing, the following posture angles will be calculated using a special software [52,58].
Measured: two months
Evaluation of Spinal Muscle Elasticity
The stiffness and elasticity of the relevant muscles will be evaluated using the MyotonPRO device, which provides information about the stiffness and elasticity of the muscle [59,60]. The participant will be asked to sit on a chair for the assessment. In this way, the participant will be able to reveal his/her completely comfortable position [60]. The relevant points will be marked and the measurement will be carried out perpendicular to this point with MyotonPRO. The measurement will be performed bilaterally on the right and left sides, and the data obtained will be recorded.
Measured: two months
Evaluation of The Strength And Endurance of The Spine Stabilization Muscles
The Stabilizer Pressure Biofeedback Unit will be used to measure the strength with Posterior pelvic tilt movement, isolated Transversus Abdominis strength measurement and Deep Cervical Flexors strength and endurance assessment will be performed using the Stabilizer Pressure Biofeedback Unit [61,62]. The McGill protocol will be used to evaluate core endurance [63].
Measured: two months
Measurement of The Strength With The Posterior Pelvic Tilt Movement
The participant is placed on his back, with the midpoint of the cuff placed on the midpoint of the line connecting both crista iliacae. The manometer valve is closed and the cuff is inflated to a pressure of 40 mm-Hg, and the participant is asked to press his/her waist down without moving his/her head, shoulders and knees, and to wait for 10 seconds without holding his/her breath. The pressure value on the manometer is recorded. The measurement is repeated 3 times with 30-second rest periods, and the maximum value is accepted as the Posterior pelvic tilt muscle strength [64,65].
Measured: two months
Transversus Abdominis Strength Measurement
After the participant is laid face down, the pressure biofeedback unit cuff is placed between the midpoint of the line connecting both spina iliaca anterior superiors and the umbilicus. The participant is asked to breathe comfortably in the abdomen, the valve of the manometer is closed and the cuff is inflated to a pressure of 70 mm-Hg. The participant is asked to pull his abdomen in without moving his spine and pelvis and wait for 10 seconds. The amount of pressure decrease in the manometer is recorded. The measurement is repeated 3 times with 30-second rest periods and the maximum value is recorded as M. transversus abdominis muscle strength[61,66-68].
Measured: two months
Endurance Measurement With Deep Cervical Flexor Muscle Strength With Stabilizer
For measurement, the patient is laid on his/her back on a flat surface. The knees should be bent and the feet should be flat on the floor. The neck is placed in a natural position without a pillow under the head. The stabilizer is placed under the patient's neck, between the occiput and cervical vertebrae. Initially, it is set to 20 mmHg pressure. The patient is instructed to increase the pressure on the stabilizer by slightly pulling the chin in and keeping the head in a neutral position. This movement allows the deep cervical flexor muscles to work actively. The patient gradually increases the pressure to 22 mmHg, 24 mmHg, 26 mmHg, 28 mmHg and 30 mmHg. Each pressure level is held for 10 seconds. If there is no increase in the pressure levels or the patient cannot control the movement, the test is stopped. The value that the error last held for 10 seconds is recorded [69].
Measured: two months
Assessment of Core Endurance
To be assessed using the McGill protocol [63]. Measurements are made using a stopwatch, and results are recorded in seconds. Tests will be terminated when the subject loses position or when the subject says they cannot continue the test [70].
For the Modified 'Biering-Sorensen' Trunk Extension, the subject is positioned in a prone position with the pelvis, hips, and knees on the bed. The subject is asked to extend their upper body straight forward from the edge of the treatment table.
For the Trunk Flexors, the subject is positioned with the trunk in 60° flexion, with the knees and hips in 90° flexion. The test is terminated when 60° of trunk flexion is lost.
For the Prone Bridge, the individual is asked to lie face down, with their elbows flexed, and lift their body up by placing their weight on their forearms and toes. The test is terminated when the position is disrupted.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for DynapeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aynur Ayazzade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aynur Ayazzade, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621875
- Sponsor's protocol ID
- ATU-FTR-AY-01
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Orsso CE, Tibaes JRB, Oliveira CLP, Rubin DA, Field CJ, Heymsfield SB, Prado CM, Haqq AM. Low muscle mass and strength in pediatrics patients: Why should we care? Clin Nutr. 2019 Oct;38(5):2002-2015. doi: 10.1016/j.clnu.2019.04.012. Epub 2019 Apr 18.
PubMed 31031136Clark BC, Manini TM. Functional consequences of sarcopenia and dynapenia in the elderly. Curr Opin Clin Nutr Metab Care. 2010 May;13(3):271-6. doi: 10.1097/MCO.0b013e328337819e.
PubMed 20154609Manini TM, Clark BC. Dynapenia and aging: an update. J Gerontol A Biol Sci Med Sci. 2012 Jan;67(1):28-40. doi: 10.1093/gerona/glr010. Epub 2011 Mar 28.
PubMed 21444359Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, Tylavsky FA, Rubin SM, Harris TB. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. J Gerontol A Biol Sci Med Sci. 2006 Jan;61(1):72-7. doi: 10.1093/gerona/61.1.72.
PubMed 16456196Xue QL, Beamer BA, Chaves PH, Guralnik JM, Fried LP. Heterogeneity in rate of decline in grip, hip, and knee strength and the risk of all-cause mortality: the Women's Health and Aging Study II. J Am Geriatr Soc. 2010 Nov;58(11):2076-84. doi: 10.1111/j.1532-5415.2010.03154.x.
PubMed 21054287Clark BC, Manini TM. What is dynapenia? Nutrition. 2012 May;28(5):495-503. doi: 10.1016/j.nut.2011.12.002.
PubMed 22469110Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Andreo-Lopez MC, Zarco-Martin MT, Contreras-Bolivar V, Fernandez-Soto ML. Prevalence of Sarcopenia and Dynapenia and Related Clinical Outcomes in Patients with Type 1 Diabetes Mellitus. Nutrients. 2023 Nov 24;15(23):4914. doi: 10.3390/nu15234914.
PubMed 38068772Ammar A, Brach M, Trabelsi K, Chtourou H, Boukhris O, Masmoudi L, Bouaziz B, Bentlage E, How D, Ahmed M, Muller P, Muller N, Aloui A, Hammouda O, Paineiras-Domingos LL, Braakman-Jansen A, Wrede C, Bastoni S, Pernambuco CS, Mataruna L, Taheri M, Irandoust K, Khacharem A, Bragazzi NL, Chamari K, Glenn JM, Bott NT, Gargouri F, Chaari L, Batatia H, Ali GM, Abdelkarim O, Jarraya M, Abed KE, Souissi N, Van Gemert-Pijnen L, Riemann BL, Riemann L, Moalla W, Gomez-Raja J, Epstein M, Sanderman R, Schulz SV, Jerg A, Al-Horani R, Mansi T, Jmail M, Barbosa F, Ferreira-Santos F, Simunic B, Pisot R, Gaggioli A, Bailey SJ, Steinacker JM, Driss T, Hoekelmann A. Effects of COVID-19 Home Confinement on Eating Behaviour and Physical Activity: Results of the ECLB-COVID19 International Online Survey. Nutrients. 2020 May 28;12(6):1583. doi: 10.3390/nu12061583.
PubMed 32481594Faulkner JA, Larkin LM, Claflin DR, Brooks SV. Age-related changes in the structure and function of skeletal muscles. Clin Exp Pharmacol Physiol. 2007 Nov;34(11):1091-6. doi: 10.1111/j.1440-1681.2007.04752.x.
PubMed 17880359Wahlstrom J. Ergonomics, musculoskeletal disorders and computer work. Occup Med (Lond). 2005 May;55(3):168-76. doi: 10.1093/occmed/kqi083.
PubMed 15857896Callaghan JP, McGill SM. Low back joint loading and kinematics during standing and unsupported sitting. Ergonomics. 2001 Feb 20;44(3):280-94. doi: 10.1080/00140130118276.
PubMed 11219760Herzog W. Mechanisms of enhanced force production in lengthening (eccentric) muscle contractions. J Appl Physiol (1985). 2014 Jun 1;116(11):1407-17. doi: 10.1152/japplphysiol.00069.2013. Epub 2013 Feb 21.
PubMed 23429875Rassier DE, MacIntosh BR, Herzog W. Length dependence of active force production in skeletal muscle. J Appl Physiol (1985). 1999 May;86(5):1445-57. doi: 10.1152/jappl.1999.86.5.1445.
PubMed 10233103Flatters I, Mushtaq F, Hill LJ, Holt RJ, Wilkie RM, Mon-Williams M. The relationship between a child's postural stability and manual dexterity. Exp Brain Res. 2014 Sep;232(9):2907-17. doi: 10.1007/s00221-014-3947-4. Epub 2014 May 14.
PubMed 24825824
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of The Presence Of Dynapenia On Posture, Spine Muscle Elasticity, Strength And Endurance In Young Adults
- ClinicalTrials.gov ID
- NCT06621875
- Acronym / sponsor ID
- ATU-FTR-AY-01
- Conditions
- Dynapenia, Muscle Weakness, Sarcopenia
- Keywords
- Muscle strength, Sarcopenia, Posture, Muscle elasticity, Muscle endurance, Dynapenia, Hand Grip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aynur AyazzadeUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to determine the effect of dynapenia on posture, spinal muscle elasticity, strength and endurance in young adults.
Detailed description
Skeletal muscle plays an important role in general health and physical development throughout the life cycle [1]. Skeletal muscle strength and performance are of critical importance in performing daily activities, maintaining mobility, and maintaining general health. Therefore, changes in general muscle strength and performance due to various reasons differentiate muscle contraction quality and neural activation, facilitating for the concept of 'dynapenia' [2,3].
Dynapenia is defined as a decrease in performance and/or strength without loss of muscle mass [4]. Although dynapenia, which facilitates for morbidity and mortality [5,7], is a well-defined condition in the elderly, there is very limited information about its prevalence and causes in young people [8]. Dynapenia, which has many negative effects on quality of life and daily functioning for the general population [9], is considered a form of accelerated muscle aging and can be defined as the "pre-sarcopenia stage" [10].
When other causes of dynapenia are examined in the literature; age and chronic diseases have been emphasized, but it has been overlooked that one of the most important modifiable factors, inadequate physical activity, can facilitate for dynapenia, especially in young people [4]. The COVID-19 pandemic that started in 2020 and the quarantine and similar measures taken subsequently have led to a decrease in physical activity levels in young people and an increase of approximately 28% in daily sitting time [11]. Low physical activity levels and the resulting decrease in muscle strength and performance can facilitate for dynapenia in young individuals [4,12].
Individuals who spend a long time in front of the computer also struggle with many health problems caused by being inactive for a long time, especially in the neck and waist [13,14]. Posture that is disrupted by the side effects of sitting for a long time can cause a decrease in muscle length and/or elasticity in certain groups of muscles [15]. Changes in the muscle also lead to a decrease in muscle strength over time [16,17], which can be an accelerating factor for dynapenia.
In the literature, many studies have addressed postural disorders, spinal muscle elasticity, muscle strength and endurance with the functional strength parameter handgrip strength [18,21], but no study has examined these parameters in young individuals with dynapenia. When deciding on the presence of dynapenia, handgrip strength is the most important parameter that provides information about general muscle strength. However, changes in the spine in individuals with dynapenia, whose handgrip strength and general muscle performance are reduced, have been ignored in the literature.
Evaluating posture, spinal muscle strength, elasticity and endurance in individuals with dynapenia can be a fundamental step in preparing preventive and therapeutic algorithms against dynapenia. The strength and endurance of spinal muscles can play a critical role in providing postural control, preserving movement functions and reducing the risk of injury, especially in individuals with dynapenia. Therefore, examining factors related to the spine in the presence of dynapenia in young individuals can make significant contributions to developing preventive health strategies, increasing functional capacities and improving quality of life.
According to above information; The aim of the present study was to determine the effect of dynapenia on posture, spinal muscle elasticity, strength and endurance in young adults.
Data collection will be carried out as follows: Participants' height, weight, body mass index and smoking, average time spent in front of the screen during the day (hours of daily use x years of use), presence of Covid-19, number of cases and when it occurred will be recorded verbally. Physical activity level will be assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-SF) [22,23]; average smartphone usage time with the Smartphone Addiction Scale Short Form [24], and sleep quality (Pittsburgh Sleep Quality Index) [25]. Those with no decrease in muscle mass but a decrease in muscle strength and/or performance will be included in the 'dypenia group', and those with no decrease in muscle mass, muscle function and performance will be included in the 'control group'.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynapenia Group | – | –Those with no decrease in muscle mass but decreased muscle strength and/or performance will be included in the 'dynapenia group'. |
| Control Group | – | –Those with no decrease in muscle mass, muscle function and performance will be included in the 'control group'. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants between the ages of 18-25 who agreed to participate in the study
Key inclusion criteria (2 listed)
- Being between the ages of 18-25
- Filling out all the survey questions
Key exclusion criteria (5 listed)
- Presence of chronic diseases that may affect the musculoskeletal system (diabetes, heart disease, neurological disorders)
- Use of medications that may affect muscle functions (corticosteroids, muscle relaxants)
- Presence of serious musculoskeletal injury within the last six months
- Presence of surgery and/or pain related to the musculoskeletal system
- History of eating disorders such as anorexia nervosa, bulimia nervosa were defined as exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bioelectrical Impedance Analysis
Time frame: two months
Bioelectrical impedance analysis is a method used to evaluate body composition [30]. Impedance refers to the resistance of tissue to electric current and is inversely proportional to conductivity. For example, components with high specific resistance such as bone and fat tissue make it difficult for electric current to pass, while components with low resistance such as skeletal muscle and visceral organs can easily conduct electric current. This principle forms the basis of bioelectrical impedance analysis [31,32]. Values of < 8.87 kg/m2 in men and < 6.42 kg/m2 in women were considered low muscle mass [9]. The Tanita BC 401 device will be used in the current study. Participants will be informed before the BIA measurement and will be asked not to drink alcohol for up to 48 hours, not to eat or drink 4 hours before, not to consume tea, coffee and cola for 12 hours before, and not to exercise. In addition, women's measurements will be taken outside of the menstrual period [33,34].
Assessment of Muscle Strength
Time frame: two months
Grip strength, will be measured using the JAMAR hand dynamometer and standardized protocol [37]. The JAMAR hand dynamometer is a reliable and most widely used measurement tool for measuring static grip strength [35,38]. Measurements are based on the principle of compressing two parallel bars. The participant is given a position suitable for holding and grip strength and the evaluation is made [38,41]. The needle of the JAMAR Hand Dynamometer can measure up to 90 kg [37,39,42]. The person should sit on a seat without arm support, with the arm in adduction and neutral rotation, the elbow in 90-degree flexion and the forearm in a neutral position [43,44]. The average of three trials for each hand was used to determine general grip strength. Inadequacy in hand grip strength was determined as less than 20 kg for women and less than 30 kg for men [45].
Assessment of Muscle Performance: 4-Meter Walk Test(4-MWT)
Time frame: two months
4-Meter Walk Test(4-MWT): (4-MWT) is a walking speed test that evaluates functional limitations and physical performance. (4-MWT) is a widely used test due to its simplicity and high test-retest reliability [46]. Test walking speed is the most commonly used and practical method for evaluating muscle performance in the clinic. A normal value is approximately 3.57 seconds. Additionally, walking speeds of less than 0.8 m/s have been associated with a risk of falling [46,49].
Assessment of Muscle Performance: Sit-to-Stand Test(SST)
Time frame: two months
Sit-to-Stand Test(SST): The participant is asked to stand up and sit down completely from a chair for one minute with the arms crossed at chest height from a standard chair height of 45 cm. The number of times the person stands up and sits down completely constitutes the total score [50]. During the test, the participant is seated upright on a chair with their feet touching the floor. The person's arms are crossed in front of their chest. The test is started with the command and the number of times the person gets up completely within 30 seconds is recorded. Only a chair and a stopwatch are required for the test. In the evaluations made for young adults, while for men, results below 15 repetitions in the 30-second sit-to-stand test can be considered as poor performance, this limit is determined as 12 repetitions for women [51].
7 secondary outcomes
Assessment of Posture Angles
Time frame: two months
Evaluation of Spinal Muscle Elasticity
Time frame: two months
Evaluation of The Strength And Endurance of The Spine Stabilization Muscles
Time frame: two months
Measurement of The Strength With The Posterior Pelvic Tilt Movement
Time frame: two months
Transversus Abdominis Strength Measurement
Time frame: two months
Endurance Measurement With Deep Cervical Flexor Muscle Strength With Stabilizer
Time frame: two months
Assessment of Core Endurance
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 31031136Orsso CE, Tibaes JRB, Oliveira CLP, Rubin DA, Field CJ, Heymsfield SB, Prado CM, Haqq AM. Low muscle mass and strength in pediatrics patients: Why should we care? Clin Nutr. 2019 Oct;38(5):2002-2015. doi: 10.1016/j.clnu.2019.04.012. Epub 2019 Apr 18.
- Background: PubMed 20154609Clark BC, Manini TM. Functional consequences of sarcopenia and dynapenia in the elderly. Curr Opin Clin Nutr Metab Care. 2010 May;13(3):271-6. doi: 10.1097/MCO.0b013e328337819e.
- Background: PubMed 21444359Manini TM, Clark BC. Dynapenia and aging: an update. J Gerontol A Biol Sci Med Sci. 2012 Jan;67(1):28-40. doi: 10.1093/gerona/glr010. Epub 2011 Mar 28.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Dynapenia and Muscle Weakness, run by Aynur Ayazzade.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aynur Ayazzade (+905010856913, aynurayazzadeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioelectrical Impedance Analysis (time frame: two months). The study lists 4 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 NCT06621875, which also lists 22 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 16 Oct 2024.