Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program

NCT05019820 | Unknown Phase 4

• 1 other identifier: MustafaKU-Sar-KOA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this thesis; To define sarcopenia in knee osteoarthritis with ultrasonography and to evaluate changes in muscle structure in sarcopenia after isokinetic exercise application ultrasonographically. The investigators will evaluate the effect of isokinetic exercise therapy in sarcopenic patients with knee osteoarthritis with VAS (Visual Analog Scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Then, the hand grip strength will be evaluated with a dynamometer, and its effects on physical performance will be evaluated by 6 meters walking and chair rising tests.

Conditions

Osteoarthritis of the Knee; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle architecture

  Determination of muscle architecture change with ultrasonography after isokinetic exercise

  Six weeks

Secondary Outcomes (5)

• Knee pain

  Six weeks

• Functional status

  Six weeks

• Hand grip strength

  Six weeks

• Walking speed

  Six weeks

• Time to get out of the chair

  Six weeks

Study Arms (2)

Sarcopenia and osteoarthritis group

ACTIVE COMPARATOR

Women aged 45-65 years diagnosed with sarcopenia and knee osteoarthritis

Other: Knee strengthening exercises with isokinetic dynamometer

Without osteoarthritis and sarcopenia group

OTHER

Women aged 45-65 years without a diagnosis of knee osteoarthritis and sarcopenia

Other: Strengthening around the knees with home exercise programe

Interventions

Knee strengthening exercises with isokinetic dynamometer OTHER

18 sessions of strengthening exercises around the knee with an isokinetic dynamometer 3 days a week

Sarcopenia and osteoarthritis group

Strengthening around the knees with home exercise programe OTHER

18 sessions of strengthening exercises for the muscles around the knee at home, 3 days a week

Without osteoarthritis and sarcopenia group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Among the 45-65 age group, 30 female patients diagnosed with knee osteoarthritis (Stage 1-2-3) and sarcopenia together
• Among the 45-65 age group, 30 females without osteoarthritis and sarcopenia will be included in the study as the control group.

You may not qualify if:

• Diabetes Mellitus,
• Severe Coronary Artery Disease / Congestive Heart Failure,
• Severe Liver Failure,
• Neuromuscular disease,
• Lower extremity surgery,
• Rheumatological disease,
• Those who use walking aids

Sponsors & Collaborators

• Sema Dağcı: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Antakya, 31000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Spinoso DH, Bellei NC, Marques NR, Navega MT. Quadriceps muscle weakness influences the gait pattern in women with knee osteoarthritis. Adv Rheumatol. 2018 Aug 31;58(1):26. doi: 10.1186/s42358-018-0027-7.

  PMID: 30657091 BACKGROUND

• Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.

  PMID: 18821647 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

• Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

  PMID: 32941253 BACKGROUND

• Papalia R, Zampogna B, Torre G, Lanotte A, Vasta S, Albo E, Tecame A, Denaro V. Sarcopenia and its relationship with osteoarthritis: risk factor or direct consequence? Musculoskelet Surg. 2014 Jun;98(1):9-14. doi: 10.1007/s12306-014-0311-6. Epub 2014 Jan 31.

  PMID: 24482109 BACKGROUND

• Baroni BM, Geremia JM, Rodrigues R, De Azevedo Franke R, Karamanidis K, Vaz MA. Muscle architecture adaptations to knee extensor eccentric training: rectus femoris vs. vastus lateralis. Muscle Nerve. 2013 Oct;48(4):498-506. doi: 10.1002/mus.23785. Epub 2013 Jul 15.

  PMID: 23852989 BACKGROUND

• Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183.

  PMID: 29035179 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Sarcopenia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Sema Dagci, M.D.

CONTACT

+90 326 229 10 00; semaadagci@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 25, 2021
• Study Start: August 18, 2021
• Primary Completion: November 20, 2021
• Study Completion: December 13, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

TU (1)