Knee OsteoarthritisNCT05054686
Effects of Concurrent Exercise Combinations in Knee Osteoarthritis:
A study testing Stretching and Aerobic Exercise at Clinic, Strenghthening and Aerobic Exercise and Strengthening, Stretching and Aerobic Exercises at clinic in people with Knee Osteoarthritis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Stretching and Aerobic Exercise at Clinic, Strenghthening and Aerobic Exercise and Strengthening, Stretching and Aerobic Exercises at clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Seda Baktır
Küçükçekmece, Alkent 2000, Büyükçekmece/İstanbul, 34307
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Stretching and Aerobic Exercise at Clinic, Strenghthening and Aerobic Exercise, Strengthening, Stretching and Aerobic Exercises at clinic
- Keywords
- ostearthritis, pain, proprioception, resistance training, exercise
- Medical subject headings
- Osteoarthritis, Knee, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching and Aerobic Exercise at ClinicOther
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.
Strenghthening and Aerobic ExerciseOther
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.
Strengthening, Stretching and Aerobic Exercises at clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Combination of Stretching and Aerobic Exercises at Clinic | Experimental | Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home Receives: Other: Stretching and Aerobic Exercise at Clinic |
| Combination of Strengthening and Aerobic Exercises at Clinic | Active comparator | Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home Receives: Other: Strenghthening and Aerobic Exercise |
| Combination of Strengthening, Stretching and Aerobic Exercises at Clinic | Active comparator | Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home Receives: Other: Strengthening, Stretching and Aerobic Exercises at clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index
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.
Measured: 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
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.
Measured: Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)
Pain Pressure Treshold (PPT)
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.
Measured: Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)
Secondary outcomes (2)
Proprioception
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.
Measured: Change of Inclinometric measurements from the beginning to the end of study (8 weeks).
Knee Muscle Strength
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.
Measured: Change of muscle strength measurements from the beginning to the end of study (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Jul 2019
- Primary completion30 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Parallel Group Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda BAKTIR, Istanbul University - Cerrahpasa
- Investigators
- Seda BAKTIR, MSc.PT., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054686
- Sponsor's protocol ID
- IstanbulUCSEDA
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We planned not to make group' data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Exercise Combinations on Pain, Function, and Proprioception in Knee Osteoarthritis: A Prospective Randomized Controlled Parallel Group Study
- ClinicalTrials.gov ID
- NCT05054686
- Acronym / sponsor ID
- IstanbulUCSEDA
- Conditions
- Knee Osteoarthritis
- Keywords
- ostearthritis, pain, proprioception, resistance training, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective Randomized Controlled Parallel Group Study
| Arm | Type | Receives |
|---|---|---|
| Combination of Stretching and Aerobic Exercises at Clinic | Experimental | Other: Stretching and Aerobic Exercise at ClinicCombination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home |
| Combination of Strengthening and Aerobic Exercises at Clinic | Active comparator | Other: Strenghthening and Aerobic ExerciseCombination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home |
| Combination of Strengthening, Stretching and Aerobic Exercises at Clinic | Active comparator | Other: Strengthening, Stretching and Aerobic Exercises at clinicCombination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home |
Who may qualify
- Ages
- 45 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Refusing to participation to study
- Having another orthopeadic problem ralated to lower extremity
- Having uncontrollable hypertension
- Having arterial and venous disease
- Having neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching and Aerobic Exercise at ClinicIn 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. | Other | Combination of Stretching and Aerobic Exercises at Clinic |
| Strenghthening and Aerobic ExerciseIn 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. | Other | Combination of Strengthening and Aerobic Exercises at Clinic |
| Strengthening, Stretching and Aerobic Exercises at clinicIn 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. | Other | Combination of Strengthening, Stretching and Aerobic Exercises at Clinic |
Primary outcome
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.
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.
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.
2 secondary outcomes
Proprioception
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. We planned not to make group' data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda BAKTIR, MSc.PT. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching and Aerobic Exercise at Clinic, Strenghthening and Aerobic Exercise and Strengthening, Stretching and Aerobic Exercises at clinic in people with Knee Osteoarthritis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.