Knee Osteoarthritis24008_ProtarthNCT07845838
The Effect of Training on Oxidative Stress in Patients With kneeOA.
A study testing supervised training and daily walking in people with Knee Osteoarthritis and Oxidative Stress, run by Mariette Boshuis at 1 site in Netherlands.
Trial summary
A six week patient study that intends to prove that training helps improve the life of people with osteoatritis of the knee. It looks at pain and function in daily life and markers in the blood that show stress at a cell level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Oxidative Stress
- What is being tested?
- supervised training and daily walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 May 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed Knee osteoartritis in one or both knees
Who cannot join
- not able to walk 6000 steps
- not able to participate in the training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Fysiotherapie de Rozenburcht
Capelle aan den IJssel, 2902BW
Mariette boshuis-scheenstra, Manual therapist, +31102847365, Mariette@rozenburcht.com
boudewijn Scheenstra, +31102847365, fysio@rozenburcht.com
About this study
Official title: The Effect of Training on Oxidative Stress in Patients With Osteoarthritis of the Knee. A Study of the Effects of Supervised Exercise Therapy on Oxidative Stress.
A six week patient study that intends to prove that training helps improve the life of people with osteoatritis of the knee.
It looks at pain and function in daily life and markers in the blood that show stress at a cell level.
Read the detailed description
In this study you will be part of a group one that receives 6 weeks of training (2 sessions per week) or you are part of group two that will exercise by walking 6000 steps per day.
To investigate the effect of the training and walking, there will be an first screening of your capillary blood (by use of a few drops of blood from your finger), and you will be asked to fill in some questionnaires about your symptoms, that will include a painscore and a questionair on your specific complaints. These test will be retaken at the end of your 6 weeks of training.
The study is focussed to benefit you by strengthening the muscles around your knee and improving your overall fitness.
- Conditions
- Knee Osteoarthritis, Oxidative Stress
- Being tested
- supervised training, daily walking
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised trainingOther
supervised training by a trained physical therapist, focussed on strength and overall fitness
daily walkingOther
walking 6000 steps per day unsupervised
| Study group | Role | What they receive |
|---|---|---|
| supervised training | Experimental | the patient will recieve 6 weeks of 2 supevised trainings per week as an outpatient Receives: Other: supervised training |
| walking | Active comparator | the patient will walk 6000 steps per day for the duration of 6 weeks Receives: Other: daily walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRPS Pain score
numeric pain rating scale
Measured: 6 weeks
PSPF
Patient Specific Functional Scale
Measured: 6 weeks
oxidative stress bloodmarkers
d-Roms fast test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start5 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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.
- 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
- randomised 2 group study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariette Boshuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariette Boshuis, Vrije Universiteit Brussel
- Investigators
- Aldo Scafoglieri, Prof, Principal investigator, professor at VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845838
- Sponsor's protocol ID
- 24008_Protarth
- Acronym
- 24008_Protarth
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training on Oxidative Stress in Patients With Osteoarthritis of the Knee. A Study of the Effects of Supervised Exercise Therapy on Oxidative Stress.
- ClinicalTrials.gov ID
- NCT07845838
- Acronym / sponsor ID
- 24008_Protarth / 24008_Protarth
- Conditions
- Knee Osteoarthritis, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mariette BoshuisUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
A six week patient study that intends to prove that training helps improve the life of people with osteoatritis of the knee.
It looks at pain and function in daily life and markers in the blood that show stress at a cell level.
Detailed description
In this study you will be part of a group one that receives 6 weeks of training (2 sessions per week) or you are part of group two that will exercise by walking 6000 steps per day.
To investigate the effect of the training and walking, there will be an first screening of your capillary blood (by use of a few drops of blood from your finger), and you will be asked to fill in some questionnaires about your symptoms, that will include a painscore and a questionair on your specific complaints. These test will be retaken at the end of your 6 weeks of training.
The study is focussed to benefit you by strengthening the muscles around your knee and improving your overall fitness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomised 2 group study
| Arm | Type | Receives |
|---|---|---|
| supervised training | Experimental | Other: supervised trainingthe patient will recieve 6 weeks of 2 supevised trainings per week as an outpatient |
| walking | Active comparator | Other: daily walkingthe patient will walk 6000 steps per day for the duration of 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed Knee osteoartritis in one or both knees
Key exclusion criteria (2 listed)
- not able to walk 6000 steps
- not able to participate in the training
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 |
|---|---|---|
| supervised trainingsupervised training by a trained physical therapist, focussed on strength and overall fitness | Other | supervised training |
| daily walkingwalking 6000 steps per day unsupervised | Other | walking |
Primary outcome
NRPS Pain score
Time frame: 6 weeks
numeric pain rating scale
PSPF
Time frame: 6 weeks
Patient Specific Functional Scale
oxidative stress bloodmarkers
Time frame: 6 weeks
d-Roms fast test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- A pilot randomized controlled trial evaluating outdoor community walking for knee osteoarthritis: walkLink provided by the sponsor.
- Moderate exercise is an antioxidant: upregulation of antioxidant genes by trainingLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Aldo Scafoglieri, Prof principal investigator
professor at VUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised training and daily walking in people with Knee Osteoarthritis and Oxidative Stress, run by Mariette Boshuis at 1 site in Netherlands.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Sep 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariette boshuis-scheenstra (+31102847365, Mariette@rozenburcht.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRPS Pain score (time frame: 6 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 29 Sep 2026.