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

NCT ID: NCT05019820

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2022-12-13

Brief Summary

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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.

Detailed Description

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Among the 45-65 age group who applied to Mustafa Kemal University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, 30 female patients diagnosed with knee osteoarthritis (stage 1-2-3) and sarcopenia together, and 30 individuals without osteoarthritis and sarcopenia will be included in the study as the control group.Patients with knee osteoarthritis who have been diagnosed with sarcopenia by ultrasonography will be Group I, and the control group without osteoarthritis and sarcopenia will be Group II.30 patients in Group I will be given an exercise program with isokinetic dynamometer for both knees, 30 minutes of TENS (transcutaneous electrical nerve stimulation), 20 minutes of hot packs, and home exercise program will be given lower extremity strengthening for a total of 6 weeks (18 sessions), 3 sessions per week.A diet program (protein, mineral, vitamin D supplemented) will also be given to these patients. The control group, which is group II, will be offered a home exercise program and diet for lower extremity strengthening only.Those with a history of complicated Diabetes Mellitus, Severe Coronary Artery Disease / Congestive Heart Failure, severe Liver Failure, neuromuscular disease, previous lower extremity surgery, rheumatological disease, use of walking aids will not be included in the study.The patient group and control group pre-treatment (week 0) and post-treatment (week 6) clinical; hand grip strength will be evaluated with Jamar dynamometer, walking speed will be evaluated with 6 meters walking test, lower extremity endurance will be evaluated with chair rise test, functional assessment of knee osteoarthritis will be evaluated by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and pain assessment will be evaluated by VAS (Visual Analogue scale) will be evaluated with a pain questionnaire.In addition, changes in the Rectus Femoris and Vastus Lateralis muscle architecture on the dominant side of the patients; muscle thickness, fascicle length, echogenicity, pennation angle and cross-sectional area measurements will be evaluated before treatment (0 weeks) and after treatment (6 weeks) by ultrasonography.

Conditions

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Osteoarthritis of the Knee Sarcopenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Sarcopenia and osteoarthritis group

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

Group Type ACTIVE_COMPARATOR

Knee strengthening exercises with isokinetic dynamometer

Intervention Type OTHER

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

Without osteoarthritis and sarcopenia group

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

Group Type OTHER

Strengthening around the knees with home exercise programe

Intervention Type OTHER

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

Interventions

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Knee strengthening exercises with isokinetic dynamometer

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

Intervention Type OTHER

Strengthening around the knees with home exercise programe

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sema Dağcı

OTHER

Sponsor Role lead

Responsible Party

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Sema Dağcı

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hatay Mustafa Kemal University

Hatay, Antakya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sema Dagci, M.D.

Role: CONTACT

+90 326 229 10 00 ext. 5067

Facility Contacts

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HASAN KAYA

Role: primary

+90 (326) 221 33 17

Role: backup

+90 (326) 221 33 18

References

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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.

Reference Type BACKGROUND
PMID: 30657091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18821647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30312372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32941253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24482109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23852989 (View on PubMed)

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.

Reference Type RESULT
PMID: 29035179 (View on PubMed)

Other Identifiers

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MustafaKU-Sar-KOA

Identifier Type: -

Identifier Source: org_study_id

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