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Systemic Sclerosis (SSc)NCT06598982

Investigation of Respiratory Muscle Sarcopenia in Patients With Systemic Sclerosis

An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Selcuk University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to investigate respiratory muscle sarcopenia in individuals with systemic sclerosis. The main question it aims to answer is: What is the prevalence of respiratory muscle sarcopenia in patients with systemic sclerosis? Participants body composition (bioelectrical impedance), hand grip strength… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Sclerosis (SSc), Scleroderma
How many people
85 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2024to 1 Jul 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will be conducted at Selçuk University, Faculty of Health Sciences. The study will include volunteer individuals with systemic sclerosis who are eligible to participate in the study and who are being followed up and treated with a diagnosis of scleroderma in the Department of Rheumatology. -- Purposive sampling

Who may be able to join

  • Being between the ages of 18-75
  • 2013 To be diagnosed with systemic sclerosis according to ACR/EULAR classification criteria
  • Being clinically stable
  • Ability to adapt to tests (visual, cognitive, cooperative)

Who cannot join

  • Those with neurological and/or musculoskeletal problems that may affect the work
  • Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking
  • Presence of severe infection or sepsis
  • Being diagnosed with a known additional rheumatologic disease
  • Any stage of cancer
  • Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

Yasemin GEDIKLI, MSc in PT contact

5067246602 ext. +90

yasemin.gedikli@selcuk.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Selcuk University

    Konya, Selcuklu, 42250

    Yasemin GEDIKLI, MSc in PT, 5067246602 ext. +90, yasemin.gedikli@selcuk.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

The aim of this study was to investigate respiratory muscle sarcopenia in individuals with systemic sclerosis. The main question it aims to answer is:

What is the prevalence of respiratory muscle sarcopenia in patients with systemic sclerosis? Participants body composition (bioelectrical impedance), hand grip strength (hand dynanometer), physical performance tests (5 repetition sit-and-stand test, 4-meter walk test, Timed up-and-go test) and respiratory muscle strength were evaluated.

Read the detailed description

Sarcopenia is a generalized and progressive loss of skeletal muscles and is characterized by a decrease in muscle strength, muscle mass and physical performance. It usually occurs in older people, but can also occur in people with certain diseases or who lead a very sedentary lifestyle. The European Working Group on Sarcopenia in Older People (EWGSOP) has developed guidelines for diagnosing sarcopenia and determining its severity. EWGSOP defined three conceptual stages of sarcopenia. Pre-sarcopenia is characterized by low muscle mass that does not affect muscle strength or physical performance. Sarcopenia is characterized by low muscle mass and decreased muscle strength or reduced physical performance. Severe sarcopenia is characterized when all criteria are met. Respiratory muscle sarcopenia is defined as a condition of muscle fiber atrophy and weakness that also occurs in respiratory muscles. The Japanese Respiratory Sarcopenia Study Group defined respiratory muscle sarcopenia as "whole body sarcopenia and low respiratory muscle mass with low respiratory muscle strength and/or low respiratory function". Respiratory muscle sarcopenia was also defined by Kera et al. based on peak expiratory flow rate. However, whole body sarcopenia and respiratory muscle strength are also important to define and diagnose respiratory muscle sarcopenia. The incidence of respiratory muscle sarcopenia is higher in the presence of sarcopenia. Sarcopenic respiratory failure is diagnosed when there is sarcopenia with functional impairment. Cases of respiratory sarcopenia without functional impairment are diagnosed as "at risk of sarcopenic respiratory failure". When the literature is reviewed, it is seen that there is no study on respiratory muscle sarcopenia in patients with systemic sclerosis. Therefore, the aim of this study is to examine respiratory muscle sarcopenia in patients with systemic sclerosis.

The smallest sample size of the study was 85 people with 90% power at 95% confidence interval. Data will be analyzed using IBM® SPSS® Statistics for Windows (ver. 25.0; IBM Corp, New York, USA) software. Values will be expressed as mean ± standard deviation and median (25-75 quartiles) for continuous variables and frequencies will be reported for categorical variables. Shapiro-Wilk test and histograms will be used to assess the normality distribution of the data. Pearson correlation coefficient will be used to evaluate the parameters associated with respiratory muscle strength. Binary Logistic Regression Analysis, which is used to estimate whether the dependent variable belongs to two categorical classes, will be used to determine the risk factors for respiratory muscle sarcopenia.

Keywords
respiration, sarcopenia, diaphragm, muscle strength
Medical subject headings
Scleroderma, Systemic, Scleroderma, Diffuse, Respiratory Aspiration, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06598982
Study groupRoleWhat they receive
patients with systemic sclerosisNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory Muscle Sarcopenia Assessment

    The diagnosis of respiratory muscle sarcopenia will also be made by combining the results of secondary measurements.

    Participants included in the study:

    • Hand grip strength \<27 kg for men and \<16 kg for women,
    • Bioelectrical Impedance Analysis (Skeletal muscle mass (SMM)\<20 kg for men and \< 15 kg for women) the participant is diagnosed with sarcopenia. They will also be diagnosed with a frailty phenotype based on the results of the Timed Stand and Walk Test, the 4 meter walk test and the 5 Repetition Sit and Stand Test.

    Patients diagnosed with sarcopenia will be diagnosed with respiratory muscle sarcopenia if respiratory muscle weakness is also detected.

    Measured: baseline

Secondary outcomes (7)

  1. Grip Force Measurement

    The hand muscle grip strength of the individuals will be measured with a hand dynamometer. During the measurement, the position recommended by the American Association of Hand Therapists (ASHT); the participant will be in an upright sitting position and no arm support will be allowed on the sitting surface. The elbow and knee angle will be set to 90°. The wrist will be held without deviation. The measurement will be performed 3 times with an interval of 10 seconds and the highest value will be used in the study.

    Measured: baseline

  2. 4 Meter Walking Speed Test (4MWT)

    4MWT is a measure of walking speed, a vital sign of mobility and functionality. In older adults, walking speed is a clinical indicator of conditions such as frailty and sarcopenia. Participants were instructed to start walking at their normal speed 2 m behind the "start point" and continue until they passed the "end point". Using a stopwatch, the time taken for each participant to walk the 4 m distance between the "start" and "end" point will be measured. This will be used to calculate walking speed (distance/time).

    Measured: baseline

  3. Timed Up and Go Test (TUG)

    This functional test measures the time it takes for an individual to stand up from a standard chair, walk 3 m at normal speed, turn around, walk back to the starting point and sit down. Using a stopwatch, participants test scores are recorded in seconds.

    Measured: baseline

  4. 5 Repetition Sit and Stand Test

    An armless chair with a straight back support and a rigid seat at a height of 48 cm from the floor will be fixed to the wall. Participants will be asked to sit on the chair and come forward in the chair until their feet are flat on the floor. Participants will be asked to do a "stand and sit" movement once with their arms crossed across their chest. The test will be terminated for those who cannot complete the task or need assistance. Those who successfully complete the first task will be asked to perform five consecutive stand and sit as fast as possible. The timing is started with the command start and stopped at the end of the fifth posture. Our participants test scores will be recorded in seconds using a stopwatch.

    Measured: baseline

  5. Respiratory muscle strength

    Intraoral pressure will be measured with a measuring device. They are easily applicable and simple measurements. Maximal voluntary inspiratory and expiratory pressures (MIP and MEP) are the most commonly used noninvasive methods to measure respiratory muscle strength. It is based on Müller (maximal inspiration) and Valsalva (maximal expiration).

    Measured: baseline

  6. Demographic and Clinical Information

    Information on age, height (meter), body weight (kg), body mass index(kg/m²), gender, educational status, occupation, medication use, exercise habits and disease will be evaluated. These data will be recorded on pre-prepared forms.

    Measured: baseline

  7. Body composition

    Body mass and body composition will be measured using bioelectrical impedance method. The variables to be assessed are body mass index (BMI = body mass (kg)/height2 (m)2 ), fat mass (pFM) expressed as a percentage of body mass, fat-free mass (FFM) expressed in kilograms, and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. Data will be collected with a bioelectrical impedance device and recorded on pre-prepared forms.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Jul 2024
  3. Primary completion2 Jan 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598982
Sponsor's protocol ID
SelcukU-FTR-YG-02
Status last verified
Sep 2024
First submitted
10 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sousa-Santos AR, Amaral TF. Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review. BMC Geriatr. 2017 Oct 16;17(1):238. doi: 10.1186/s12877-017-0625-y.

    PubMed 29037155

  • Nagano A, Wakabayashi H, Maeda K, Kokura Y, Miyazaki S, Mori T, Fujiwara D. Respiratory Sarcopenia and Sarcopenic Respiratory Disability: Concepts, Diagnosis, and Treatment. J Nutr Health Aging. 2021;25(4):507-515. doi: 10.1007/s12603-021-1587-5.

    PubMed 33786569

  • Mehmet H, Robinson SR, Yang AWH. Assessment of Gait Speed in Older Adults. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):42-52. doi: 10.1519/JPT.0000000000000224.

    PubMed 30720555

  • Maggio M, Ceda GP, Ticinesi A, De Vita F, Gelmini G, Costantino C, Meschi T, Kressig RW, Cesari M, Fabi M, Lauretani F. Instrumental and Non-Instrumental Evaluation of 4-Meter Walking Speed in Older Individuals. PLoS One. 2016 Apr 14;11(4):e0153583. doi: 10.1371/journal.pone.0153583. eCollection 2016.

    PubMed 27077744

  • Kera T, Kawai H, Hirano H, Kojima M, Watanabe Y, Motokawa K, Fujiwara Y, Ihara K, Kim H, Obuchi S. Definition of Respiratory Sarcopenia With Peak Expiratory Flow Rate. J Am Med Dir Assoc. 2019 Aug;20(8):1021-1025. doi: 10.1016/j.jamda.2018.12.013. Epub 2019 Feb 6.

    PubMed 30737167

  • Hulzebos E, Takken T, Reijneveld EA, Mulder MMG, Bongers BC. Reference Values for Respiratory Muscle Strength in Children and Adolescents. Respiration. 2018;95(4):235-243. doi: 10.1159/000485464. Epub 2018 Jan 17.

    PubMed 29342462

  • Greco F, Tarsitano MG, Cosco LF, Quinzi F, Folino K, Spadafora M, Afzal M, Segura-Garcia C, Maurotti S, Pujia R, Pujia A, Buono P, Emerenziani GP. The Effects of Online Home-Based Pilates Combined with Diet on Body Composition in Women Affected by Obesity: A Preliminary Study. Nutrients. 2024 Mar 21;16(6):902. doi: 10.3390/nu16060902.

    PubMed 38542813

  • Cruz-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 20392703

  • Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.

    PubMed 19207142

  • Calderon LM, Pope JE. Scleroderma epidemiology update. Curr Opin Rheumatol. 2021 Mar 1;33(2):122-127. doi: 10.1097/BOR.0000000000000785.

    PubMed 33481429

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Sclerosis (SSc) and Scleroderma, run by Selcuk University at 1 site in Turkey (Türkiye).

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 4 inclusion and 6 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 Yasemin GEDIKLI, MSc in PT (5067246602 ext. +90, yasemin.gedikli@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Muscle Sarcopenia Assessment (time frame: baseline). 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 NCT06598982, which also lists 10 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 19 Sep 2024.

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