Knee OsteoarthritisKOA-PAINNCT04362618

Exercise Therapy for Osteoarthritis Pain: How Does it Work?

A study testing Muscle Strengthening Training and Behavioral graded activity in people with Knee Osteoarthritis, run by Vrije Universiteit Brussel at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Muscle Strengthening Training and Behavioral graded activity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteBelgium
Study dates: 5 Mar 2020to 31 Dec 2023
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

KOA according to the clinical American College of Rheumatology (ACR) criteria. The clinical ACR criteria for KOA are: knee pain and at least 3 of the 6 following features: age ≥50, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement, no palpable warmth. KOA will be confirmed with radiographs, including anterior-posterior (AP) and medio-lateral (ML) radiographs for imaging the tibiofemoral joint, and an axial view for imaging the patellofemoral joint. Kellgren and Lawrence (K\&L) grading system for OA will be applied, with K\&L grade 2 or higher defined as OA; radiographic KOA is defined as definite osteophytes and possible joint space narrowing.
pain, nominated by the patient as 3 /10 or higher on a visual analogue scale on most days of the last 3 months
aged ≥ 50 years.

Who cannot join

treatment with exercise therapy or joint infiltrations (e.g., corticosteroids, hyaluronic acid) in the preceding 6 months;
being on a waiting list for knee replacement;
any contra-indication for exercise therapy as established by the treating physician;
corticosteroid infiltrations in the last 6 months;
cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score <23/30);
unable to understand the Dutch language;
inflammation unrelated to OA (e.g. due to acute or chronic infection) established by CRP>10mg/L.
presence of a disorder and/or medication that influences pain and/or the immune system

Trial locations and contacts

1 site in 1 country.

Ivan Bautmans, PhD contact

+3224774207

ivan.bautmans@vub.be

Belgium1 site, 1 recruiting

Vrije Universiteit Brussel (VUB)
Jette, Brussels Capital, 1090
Ivan Bautmans, PhD, +3224774207, ivan.bautmans@vub.be
Sofie Puts, MSc
Recruiting

Other trials in Belgium

About this study

International guidelines recommend exercise as the first choice treatment for knee osteoarthritis (KOA). Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on KOA pain, but the mechanisms of action are unclear. Understanding these mechanisms is necessary to tailor exercise therapy towards specific mediators and thereby optimize treatment effects. Based on previous studies, both exercise-induced anti-inflammation and endogenous analgesia are promising pathways for pain reduction after exercise therapy. This study aims to examine (anti)-inflammation and endogenous analgesia as mediators for the effect of MST and/or BGA on pain in patients with KOA. Therefore, a 3-arm randomized clinical trial is established: 12 weeks of muscle strengthening training, behavioural graded activity or control. Mediator analysis will be performed. Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists. The results of this research will also find their way into clinical practice: thanks to the current project, tailoring exercise therapy programs towards specific mechanistic factors and thereby optimizing treatment effects will be at the horizon for patients suffering from KOA.

Conditions: Knee Osteoarthritis
Being tested: Muscle Strengthening Training, Behavioral graded activity
Keywords: Osteoarthritis, Exercise, Acute effects, Inflammation, Endogenous hypoalgesia
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis, Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Muscle Strengthening TrainingOther
Muscle strengthening training will take place for a period of 12 weeks, in which participants will have 36 exercise sessions (18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. Muscles of the leg (i.e. quadriceps, hip ab- and adductors) will be trained at 3 set of 10 repetitions at 80% of 1RM with the use of elastic bands. 1RM will be assessed at baseline and the exercise intensity will be progressively increased by 10% of 1RM every two sessions from 50 up to 70-80 % of 1RM. Every 6 sessions, the 1RM will be reassessed and the training resistances will be adapted.
Behavioral graded activityBehavioural
Subjects will receive a behavioural treatment integrated within the concepts of operant conditioning with exercise therapy for a period of 12 weeks, in which the subjects will have maximum 36 BGA sessions (min. 13- max. 18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. The purpose of BGA is to increase the level of activities in a time-contingent manner and increase the level of physical activity in the subject's daily lives. BGA consists of 3 phases: pain education (phase 1), treatment phase in which subjects increase their level of activity gradually (phase 2) and integration of learned principles in daily live (phase 3).

Study groups in NCT04362618
Study group	Role	What they receive
Muscle Strengthening Training (MST)-group	Experimental	Subjects allocated to the MST group (n=30) will perform a muscle strengthening training program of 12 weeks. Receives: Other: Muscle Strengthening Training
Behavioral Graded Activity (BGA)-group	Experimental	Subjects allocated to the BGA group (n=30) will perform a rehabilitation program according to the principles of behavioural graded activity for a period of 12 weeks. Receives: Behavioral: Behavioral graded activity
Control group	No intervention	Subjects allocated to the control group (n=30) have to maintain their current life-style and treatment (if any) and to refrain from other new interventions during 24 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

Knee pain as primary study outcome
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Measured: Baseline
Knee pain as primary study outcome
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Measured: during intervention: week 2 (acute)
Knee pain as primary study outcome
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Measured: during intervention: week 10 (acute)
Knee pain as primary study outcome
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Measured: post-intervention: week 13
Knee pain as primary study outcome
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Measured: post-intervention: week 26
Knee pain as primary study outcome
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Measured: post-intervention: week 64

Secondary outcomes (9)

Different subtypes of pain: pain
Pain will be measured using the Visual analogue scale (VAS).
Measured: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Different subtypes of pain: intermittent pain
Intermittent pain will be measured using a short and easily applicable self-reported measure, i.e. intermittent and constant pain (ICOAP).
Measured: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Different subtypes of pain: constant pain
Constant pain, will be measured using a short and easily applicable self-reported measure, i.e. Intermittent and constant pain (ICOAP).
Measured: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Different subtypes of pain: central sensitization
Central sensitization will be measured using an easily applicable self-reported measure i.e. Central Sensitization Inventory (CSI).
Measured: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Function in daily living (KOOS subscale)
Function in daily living will be measured using self-reported measures. The KOOS function in daily living (ADL) subscale and functioning in sports and recreation subscale are reliable and valid scales to measure function in people with osteoarthritis. The patient global assessment (PGA) is a recommended questionnaire in clinical trials of rehabilitation interventions for OA and it measures the improvement or deterioration of their condition.
Measured: Baseline, post-intervention (week 13, 26 and 64)
Function in daily living (PGA)
Function in daily living will be measured using self-reported measures. The patient global assessment (PGA) is a recommended questionnaire in clinical trials of rehabilitation interventions for OA and it measures the improvement or deterioration of their condition.
Measured: Assessed at baseline and post-intervention (at week 13, 26 and 64)
Treatment adherence
Patient adherence for the treatment sessions will be calculated as the ratio of the number of treatment sessions that were actually carried out versus the number of prescribed sessions. Compliance will be calculated as the ratio of the total training duration (recorded in the logbooks) versus the prescribed total training duration, multiplied by 100.
Measured: During the intervention (week 1-12) and at week 13
Treatment compliance
Compliance will be calculated as the ratio of the total training duration (recorded in the logbooks) versus the prescribed total training duration, multiplied by 100.
Measured: During the intervention (week 1-12) and at week 13
Health care cost effectiveness
Medical consumption, the type, dose, method of administration and frequency of analgesic, NSAID or symptom-modifying medication, as well as surgeries (total or partial knee replacements) will be recorded. Health care use will be evaluated using the combination of three questionnaires: (1) the Medical Consumption Questionnaire (2) the Productivity Cost Questionnaire and (3) the EuroQol EQ-5D.
Measured: Assessed at baseline, at week 13, 26 and 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 202031 Dec 2023

First posted27 Apr 2020
Study start5 Mar 2020
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: The patients will be randomly allocated to 12 weeks of either muscle strengthening training (MST), behavioural graded activity (BGA) or control. Randomization will be performed by using the method of randomly permuted blocks, utilising a computer-generated random number sequence. To keep both intervention groups balanced, randomization will be stratified for sex (male versus female) baseline inflammation status (hsCRP\<3mg/L versus hsCRP ≥3mg/L) and baseline central sensitization status (central sensitization inventory (CSI) score \<40 versus CSI score ≥ 40). A list with patient numbers and the group allocation that results from this randomization procedure will be securely stored and only an independent researcher will have direct access to the randomization list. Patients will be scheduled to receive their first assessment within 1 week of randomisation. Patients will be recruited in primary care and participating hospitals. Announcements will be placed in newspapers, pharmacies etc.
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04362618
Sponsor's protocol ID: G040919N_KOA_PAIN
Acronym: KOA-PAIN
Status last verified: May 2023
First submitted: 28 Feb 2020
Last updated: 30 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Beckwee D, Nijs J, Bierma-Zeinstra SMA, Leemans L, Leysen L, Puts S, Rice D, Schiphof D, Bautmans I. Exercise therapy for knee osteoarthritis pain: how does it work? A study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e074258. doi: 10.1136/bmjopen-2023-074258.
PubMed 38199628

Want to know more?

Ivan Bautmans, PhD

+3224774207

ivan.bautmans@vub.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise Therapy for Osteoarthritis Pain: How Does it Work?
ClinicalTrials.gov ID: NCT04362618
Acronym / sponsor ID: KOA-PAIN / G040919N_KOA_PAIN
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, Exercise, Acute effects, Inflammation, Endogenous hypoalgesia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 90 participants (estimated)
Lead sponsor: Vrije Universiteit BrusselUniversity, hospital or other
Collaborators: Universitair Ziekenhuis Brussel, AZ St.-Dimpna Geel
Study start: 5 Mar 2020 (actual)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 27 Apr 2020 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: The patients will be randomly allocated to 12 weeks of either muscle strengthening training (MST), behavioural graded activity (BGA) or control. Randomization will be performed by using the method of randomly permuted blocks, utilising a computer-generated random number sequence. To keep both intervention groups balanced, randomization will be stratified for sex (male versus female) baseline inflammation status (hsCRP<3mg/L versus hsCRP ≥3mg/L) and baseline central sensitization status (central sensitization inventory (CSI) score <40 versus CSI score ≥ 40). A list with patient numbers and the group allocation that results from this randomization procedure will be securely stored and only an independent researcher will have direct access to the randomization list. Patients will be scheduled to receive their first assessment within 1 week of randomisation. Patients will be recruited in primary care and participating hospitals. Announcements will be placed in newspapers, pharmacies etc.

Arm	Type	Receives
Muscle Strengthening Training (MST)-group	Experimental	Other: Muscle Strengthening TrainingSubjects allocated to the MST group (n=30) will perform a muscle strengthening training program of 12 weeks.
Behavioral Graded Activity (BGA)-group	Experimental	Behavioral: Behavioral graded activitySubjects allocated to the BGA group (n=30) will perform a rehabilitation program according to the principles of behavioural graded activity for a period of 12 weeks.
Control group	No intervention	–Subjects allocated to the control group (n=30) have to maintain their current life-style and treatment (if any) and to refrain from other new interventions during 24 weeks.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

KOA according to the clinical American College of Rheumatology (ACR) criteria. The clinical ACR criteria for KOA are: knee pain and at least 3 of the 6 following features: age ≥50, morning stiffness <30 minutes, crepitus, bony tenderness, bony enlargement, no palpable warmth. KOA will be confirmed with radiographs, including anterior-posterior (AP) and medio-lateral (ML) radiographs for imaging the tibiofemoral joint, and an axial view for imaging the patellofemoral joint. Kellgren and Lawrence (K\&L) grading system for OA will be applied, with K\&L grade 2 or higher defined as OA; radiographic KOA is defined as definite osteophytes and possible joint space narrowing.
pain, nominated by the patient as 3 /10 or higher on a visual analogue scale on most days of the last 3 months
aged ≥ 50 years.

Key exclusion criteria (8 listed)

treatment with exercise therapy or joint infiltrations (e.g., corticosteroids, hyaluronic acid) in the preceding 6 months;
being on a waiting list for knee replacement;
any contra-indication for exercise therapy as established by the treating physician;
corticosteroid infiltrations in the last 6 months;
cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score <23/30);

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
Muscle Strengthening TrainingMuscle strengthening training will take place for a period of 12 weeks, in which participants will have 36 exercise sessions (18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. Muscles of the leg (i.e. quadriceps, hip ab- and adductors) will be trained at 3 set of 10 repetitions at 80% of 1RM with the use of elastic bands. 1RM will be assessed at baseline and the exercise intensity will be progressively increased by 10% of 1RM every two sessions from 50 up to 70-80 % of 1RM. Every 6 sessions, the 1RM will be reassessed and the training resistances will be adapted.	Other	Muscle Strengthening Training (MST)-group
Behavioral graded activitySubjects will receive a behavioural treatment integrated within the concepts of operant conditioning with exercise therapy for a period of 12 weeks, in which the subjects will have maximum 36 BGA sessions (min. 13- max. 18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. The purpose of BGA is to increase the level of activities in a time-contingent manner and increase the level of physical activity in the subject's daily lives. BGA consists of 3 phases: pain education (phase 1), treatment phase in which subjects increase their level of activity gradually (phase 2) and integration of learned principles in daily live (phase 3).	Behavioural	Behavioral Graded Activity (BGA)-group

Primary outcome

Knee pain as primary study outcome
Time frame: Baseline
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Knee pain as primary study outcome
Time frame: during intervention: week 2 (acute)
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Knee pain as primary study outcome
Time frame: during intervention: week 10 (acute)
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Knee pain as primary study outcome
Time frame: post-intervention: week 13
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Knee pain as primary study outcome
Time frame: post-intervention: week 26
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.
Knee pain as primary study outcome
Time frame: post-intervention: week 64
Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.

9 secondary outcomes

Different subtypes of pain: pain
Time frame: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Different subtypes of pain: intermittent pain
Time frame: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Different subtypes of pain: constant pain
Time frame: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Different subtypes of pain: central sensitization
Time frame: Baseline, during intervention (week 2 and 10), post-intervention (week 13, 26 and 64)
Function in daily living (KOOS subscale)
Time frame: Baseline, post-intervention (week 13, 26 and 64)
Function in daily living (PGA)
Time frame: Assessed at baseline and post-intervention (at week 13, 26 and 64)
Treatment adherence
Time frame: During the intervention (week 1-12) and at week 13
Treatment compliance
Time frame: During the intervention (week 1-12) and at week 13
Health care cost effectiveness
Time frame: Assessed at baseline, at week 13, 26 and 64

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
Derived from this study: PubMed 38199628Beckwee D, Nijs J, Bierma-Zeinstra SMA, Leemans L, Leysen L, Puts S, Rice D, Schiphof D, Bautmans I. Exercise therapy for knee osteoarthritis pain: how does it work? A study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e074258. doi: 10.1136/bmjopen-2023-074258.
Individual participant dataSharing planned: No

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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.

Ivan Bautmans, PhD contact

+3224774207

ivan.bautmans@vub.be

Ivan Bautmans, PhD principal investigator

Gerontology department (GERO) and Frailty in Ageing (FRIA) research department, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, B-1090 Brussels, Belgium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Muscle Strengthening Training and Behavioral graded activity in people with Knee Osteoarthritis, run by Vrije Universiteit Brussel at 1 site in Belgium.

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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ivan Bautmans, PhD (+3224774207, ivan.bautmans@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee pain as primary study outcome (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04362618, which also lists 1 linked publication.

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 30 May 2023.