Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis

February 26, 2026 updated by: Sezen Karaborklu Argut, Istanbul University - Cerrahpasa

The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial

This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
84

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.
  • Not Applicable

Contacts and Locations

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

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 40-70 years of age,
  • Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
  • No medication for knee osteoarthritis in the past three months,
  • Subjects who understand and sign the consent form for this study.

Exclusion Criteria:

  • Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
  • Previous partial or total knee replacement of the target knee,
  • Body mass index > 30 kg/m2,
  • Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
  • Impaired cognition that impacts the ability to give informed consent,
  • Participation in another clinical trial.

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: Treatment
  • Allocation: 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.
Experimental: Group I
Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program.
Other: Exercise
Supervised exercise program
Biological: PRP
Intra-articular PRP injections to knee joint
Active Comparator: Group II
Each subject in this group will receive a treatment of supervised exercise program.
Other: Exercise
Supervised exercise program
Active Comparator: Group III
Each subject in this group will receive a treatment of three PRP injections to knee joint.
Biological: PRP
Intra-articular PRP injections to knee joint

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
Pain intensity
Time Frame: 6th week
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
6th week
Pain intensity
Time Frame: 3rd month
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
3rd month
Function
Time Frame: 6th week
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.
6th week
Functional performance - 40m fast-paced walk test
Time Frame: 6th week
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
6th week
Functional performance - 10-step stair-climb test
Time Frame: 6th week
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
6th week
Function
Time Frame: 3rd month
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.
3rd month
Functional performance - 40m fast-paced walk test
Time Frame: 3rd month
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
3rd month
Functional performance - 10-step stair-climb test
Time Frame: 3rd month
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
3rd month

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
Range of motion
Time Frame: 6th week
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
6th week
Range of motion
Time Frame: 3rd month
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
3rd month
Health related quality of life
Time Frame: 6th week
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
6th week
Health related quality of life
Time Frame: 3rd month
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
3rd month
Patient Satisfaction
Time Frame: 6th week
Patient satisfaction will be assessed by the Global Rating of Change scale.
6th week
Patient Satisfaction
Time Frame: 3rd month
Patient satisfaction will be assessed by the Global Rating of Change scale.
3rd month

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.
Istanbul University - Cerrahpasa

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.
January 31, 2021

Primary Completion (Actual)

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.
January 7, 2022

Study Completion (Actual)

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.
February 10, 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).
January 3, 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.
January 5, 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.
January 6, 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.
March 2, 2026

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.
February 26, 2026

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.
February 1, 2026

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.
  • TDK-2020-35062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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