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

Primary Purpose

Osteoarthritis of the Knee, Sarcopenia

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Knee strengthening exercises with isokinetic dynamometer
Strengthening around the knees with home exercise programe
Sponsored by
Sema Dağcı
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis of the Knee

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hatay Mustafa Kemal UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Sarcopenia and osteoarthritis group

Without osteoarthritis and sarcopenia group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Muscle architecture
Determination of muscle architecture change with ultrasonography after isokinetic exercise

Secondary Outcome Measures

Knee pain
The effect of isokinetic exercise with VAS (visual analog scale) on pain level
Functional status
Effect of isokinetic exercise on activities of daily living with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Hand grip strength
Evaluating the effect of isokinetic exercise on hand grip strength with a hand dynamometer
Walking speed
Evaluation of the change in walking speed with isokinetic exercise
Time to get out of the chair
Evaluation of the change in sitting time by standing up from the chair 5 times with isokinetic exercise

Full Information

First Posted
July 23, 2021
Last Updated
August 19, 2021
Sponsor
Sema Dağcı
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1. Study Identification

Unique Protocol Identification Number
NCT05019820
Brief Title
Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program
Official Title
Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
December 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sema Dağcı

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee, Sarcopenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sarcopenia and osteoarthritis group
Arm Type
Active Comparator
Arm Description
Women aged 45-65 years diagnosed with sarcopenia and knee osteoarthritis
Arm Title
Without osteoarthritis and sarcopenia group
Arm Type
Other
Arm Description
Women aged 45-65 years without a diagnosis of knee osteoarthritis and sarcopenia
Intervention Type
Other
Intervention Name(s)
Knee strengthening exercises with isokinetic dynamometer
Intervention Description
18 sessions of strengthening exercises around the knee with an isokinetic dynamometer 3 days a week
Intervention Type
Other
Intervention Name(s)
Strengthening around the knees with home exercise programe
Intervention Description
18 sessions of strengthening exercises for the muscles around the knee at home, 3 days a week
Primary Outcome Measure Information:
Title
Muscle architecture
Description
Determination of muscle architecture change with ultrasonography after isokinetic exercise
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Knee pain
Description
The effect of isokinetic exercise with VAS (visual analog scale) on pain level
Time Frame
Six weeks
Title
Functional status
Description
Effect of isokinetic exercise on activities of daily living with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame
Six weeks
Title
Hand grip strength
Description
Evaluating the effect of isokinetic exercise on hand grip strength with a hand dynamometer
Time Frame
Six weeks
Title
Walking speed
Description
Evaluation of the change in walking speed with isokinetic exercise
Time Frame
Six weeks
Title
Time to get out of the chair
Description
Evaluation of the change in sitting time by standing up from the chair 5 times with isokinetic exercise
Time Frame
Six weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sema Dagci, M.D.
Phone
+90 326 229 10 00
Ext
5067
Email
semaadagci@gmail.com
Facility Information:
Facility Name
Hatay Mustafa Kemal University
City
Hatay
State/Province
Antakya
ZIP/Postal Code
31000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HASAN KAYA
Phone
+90 (326) 221 33 17
Email
rektorlukyaziisleri@mku.edu.tr
Phone
+90 (326) 221 33 18
Email
semaadagci@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30657091
Citation
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.
Results Reference
background
PubMed Identifier
18821647
Citation
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.
Results Reference
background
PubMed Identifier
30312372
Citation
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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.
Results Reference
background
PubMed Identifier
32941253
Citation
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.
Results Reference
background
PubMed Identifier
24482109
Citation
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.
Results Reference
background
PubMed Identifier
23852989
Citation
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.
Results Reference
background
PubMed Identifier
29035179
Citation
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.
Results Reference
result

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

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