Investigation of Respiratory Muscle Sarcopenia in Patients with Systemic Sclerosis

NCT06598982 | Recruiting

• 1 other identifier: SelcukU-FTR-YG-02
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Systemic Sclerosis (SSc); Scleroderma

Keywords

respiration; sarcopenia; diaphragm; muscle strength

Outcome Measures

Primary Outcomes (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.

  baseline

Secondary Outcomes (7)

• Grip Force Measurement

  baseline

• 4 Meter Walking Speed Test (4MWT)

  baseline

• Timed Up and Go Test (TUG)

  baseline

• 5 Repetition Sit and Stand Test

  baseline

• Respiratory muscle strength

  baseline

Study Arms (1)

patients with systemic sclerosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42250, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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.

  PMID: 29037155 BACKGROUND

• 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.

  PMID: 33786569 BACKGROUND

• 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.

  PMID: 30720555 BACKGROUND

• 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.

  PMID: 27077744 BACKGROUND

• 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.

  PMID: 30737167 BACKGROUND

• 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.

  PMID: 29342462 BACKGROUND

• 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.

  PMID: 38542813 BACKGROUND

• 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.

  PMID: 20392703 BACKGROUND

• 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.

  PMID: 19207142 BACKGROUND

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

  PMID: 33481429 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Respiratory Aspiration; Sarcopenia

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Yasemin GEDIKLI, MSc in PT

CONTACT

5067246602; yasemin.gedikli@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Health Sciences Physiotherapy and Rehabilitation-Research assistant

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: January 2, 2025
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)