Effects of Concurrent Exercise Combinations in Knee Osteoarthritis:

February 2, 2026 updated by: Seda BAKTIR, Istanbul University - Cerrahpasa

Effects of Concurrent Exercise Combinations on Pain, Function, and Proprioception in Knee Osteoarthritis: A Prospective Randomized Controlled Parallel Group Study

This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program, Second group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.Third group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception. The aim of this study is to investigate the effects on outcome measures increasing number of exercises in one session and to determine which exercise types are more suitable to prescribe as a home program.

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.

Detailed Description

This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and bicycle exercises in the same session and strecthing exercises and walking will be given as home program in the days other than treatment session. Second group of knee osteoarthritis patients will be applied both stretching and bicycle exercises in the same session and strengthening exercises and walking will be given as home program in the days other than treatment session. Third group of knee osteoarthritis patients will be applied all stretching, strengthening and bicycle exercises in the same session and only walking exercise will be given as home program in the days other than treatment session. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception. The aim of this study is to investigate the effects increasing number of exercises in one session on outcome measures consisting of pain, function and proprioception. The pain will be evaluated both subjectively with numeric pain scale and WOMAC scale and objectively with pressure algometer. The function will be subjectively evaluated with WOMAC scale. The evaluation of joint proprioception will be evaluated with inclinometer. All the groups will be treated 2 days per week. The duration of total treatment lasts 8 weeks. All the groups practice aerobic exercises 2 days with bicycle ergometer application in the clinic, and 2 days walking outside as home program. Strecthing exercises will be applied for knee flexor and knee extensor muscles. Isometric strengthening exercises will be applied for knee extensor muscles. Isotonic strengthening exercises will be applied for hip extensor, flexor, abductor muscles and knee extensor and flexor muscles. The treatment outcomes will be evaluated at the end of 8 weeks treatment.

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.
45

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

  • Turkey (Türkiye)
    • Alkent 2000, Büyükçekmece/İstanbul
      • Küçükçekmece, Alkent 2000, Büyükçekmece/İstanbul, Turkey (Türkiye), 34307
        • Seda Baktır

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 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being diagnosed as knee osteoarthritis
  • Being between the ages 45-74
  • Being at stage 2-3 according to Kellegren Lawrence Classification
  • Having body mass index lower than 30
  • Being volunteer for participation to this study

Exclusion Criteria:

  • Refusing to participation to study
  • Having another orthopeadic problem ralated to lower extremity
  • Having uncontrollable hypertension
  • Having arterial and venous disease
  • Having neurological disease
  • Having perceptual problem
  • Having cardiac pacemaker
  • Participation to physiotherapy program in the last 6 months for the same extremity
  • Taking injection from the same extremity in the last 6 months

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: Combination of Stretching and Aerobic Exercises at Clinic
Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home
Other: Stretching and Aerobic Exercise at Clinic
In this group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.
Active Comparator: Combination of Strengthening and Aerobic Exercises at Clinic
Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home
Other: Strenghthening and Aerobic Exercise
In this group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program.
Active Comparator: Combination of Strengthening, Stretching and Aerobic Exercises at Clinic
Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home
Other: Strengthening, Stretching and Aerobic Exercises at clinic
In this group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program.

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
The Western Ontario and McMaster Universities Arthritis Index
Time Frame: Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)

The Western Ontario and McMaster Universities Arthritis Index is a questionnaire consisting of 24 items divided into 3 subscales:

Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright

Stiffness (2 items): after first waking and later in the day

Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.

The increasing scores reflect improvement of the function.
Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)
Numeric Pain Rating Scale
Time Frame: Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 likert type integers) that best reflects the intensity of his/her pain.The levels of pain felt at rest / activity / night will be evaluated. The increase in pain scores demonstrate that the health status get worse.
Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
Pain Pressure Treshold (PPT)
Time Frame: Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)
Pain Pressure Treshold is evaluated via algometric measurement that were taken from 4 point including the mid portion of patella, 3 cm medial to patellar midline, 3 cm lateral to patellar midline, 2 cm above to patellar upper boundary.The increase in algometric measurement demonstrate the development in the pain sensitivity.
Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 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
Proprioception
Time Frame: Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
Proprioception will be evaluated with digital inclinometer from 90 degree knee flexion to 30 degree knee flexion angle. The deviation from this interval reflects that the detoriation of knee joint proprioception. Therefore, decreasing deviation scores obtained from the inclinometer reflects better proprioceptive sensation.
Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
Knee Muscle Strength
Time Frame: Change of muscle strength measurements from the beginning to the end of study (8 weeks)
Muscle strength for knee flexor and extensor muscles Knee joint muscle strength was measured by using hand-held dinamometer. The measurements had taken for quadrieps and hamstring muscles. the incresing muscle strength values reflects improvement of strength of muscles around knee joint.
Change of muscle strength measurements from the beginning to the end of study (8 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.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seda BAKTIR, MSc.PT., Istanbul University - Cerrahpasa

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.
July 1, 2019

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.
April 30, 2021

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.
May 30, 2021

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).
September 12, 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.
September 14, 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.
September 23, 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.
February 4, 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 2, 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

Keywords

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.
  • IstanbulUCSEDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We planned not to make group' data available to other researchers.

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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