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

August 19, 2021 updated by: Sema Dağcı
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sarcopenia and osteoarthritis group
Women aged 45-65 years diagnosed with sarcopenia and knee osteoarthritis
Other: Knee strengthening exercises with isokinetic dynamometer
18 sessions of strengthening exercises around the knee with an isokinetic dynamometer 3 days a week
Other: Without osteoarthritis and sarcopenia group
Women aged 45-65 years without a diagnosis of knee osteoarthritis and sarcopenia
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle architecture
Time Frame: Six weeks
Determination of muscle architecture change with ultrasonography after isokinetic exercise
Six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee pain
Time Frame: Six weeks
The effect of isokinetic exercise with VAS (visual analog scale) on pain level
Six weeks
Functional status
Time Frame: Six weeks
Effect of isokinetic exercise on activities of daily living with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Six weeks
Hand grip strength
Time Frame: Six weeks
Evaluating the effect of isokinetic exercise on hand grip strength with a hand dynamometer
Six weeks
Walking speed
Time Frame: Six weeks
Evaluation of the change in walking speed with isokinetic exercise
Six weeks
Time to get out of the chair
Time Frame: Six weeks
Evaluation of the change in sitting time by standing up from the chair 5 times with isokinetic exercise
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sema Dağcı

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MustafaKU-Sar-KOA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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