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Trial · NCT07901881

The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA.

NCT07901881, Not applicable, Not yet recruiting, Mark van Loo

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA. Trials, record NCT07901881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901881

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA.
NCT number
NCT07901881
Status
Not yet recruiting
Phases
Not applicable
Enrollment
20 participants, estimated
Lead sponsor
Mark van Loo
Conditions
Knee Osteoarthritis
Interventions
EXPLOR-3
First posted
2026-10-28
Last updated
2026-10-28

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in physical activity (ActiGraph GT3x) from Phase A to Phase B to Phase A'.Daily measurements for 7-8 weeks (A+B Phase) and the last 5 days of the follow-up phase (Phase A'). Duration of follow-up phase is 12 weeks.
Physical activity will be assessed using ActiGraph GT3x (ActiGraph, Pensacola, Florida) triaxial accelerometers. Participants will be instructed to wear the accelerometer on their thigh while they are awake during the A and B phase and the last 5 days of the A' phase. Physical activity thresholds will be used to distinguish between sedentary behaviour and light, moderate and vigorous physical activity.
PrimaryChange in sedentary behaviour (ActiGraph GT3x) from Phase A to Phase B to Phase A'.Daily measurements for 7-8 weeks (A+B Phase) and the last 5 days of the follow-up phase (Phase A'). Duration of follow-up phase is 12 weeks.
Sedentary behaviour will be assessed using ActiGraph GT3x (ActiGraph, Pensacola, Florida) triaxial accelerometers. Participants will be instructed to wear the accelerometer on their thigh while they are awake during the A and B phase and the last 5 days of the A' phase. Physical activity thresholds will be used to distinguish between sedentary behaviour and light, moderate and vigorous physical activity.
SecondaryChange on the Knee Injury and Osteoarthritis Outcome Score from phase A to phase B to follow-up.At start of baseline, after 3 weeks and 6 weeks of treatment and at the end of the follow-up phase. Follow-up phase is 12 weeks.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) comprises five subscales: 1) Pain (9 items), 2) Symptoms (7), 3) Activities of Daily Living (17), 4) Sport/Rec (5), and 5) knee related Quality of Life (4). Questions are scored 0-100 (worst-best). Internal consistency is adequate (pooled Cronbach's α≈0.70-0.95) and test-retest reliability high (ICCs ≈0.85-0.90). Content validity is condition and age sensitive: ADL is more relevant in older OA cohorts and Pain in painful conditions.
SecondaryChange on the Patient Specific Functional Scale (PFPS) from phase A to phase B to follow-up.At start of baseline, after 3 weeks and 6 weeks of treatment and the end of the follow-up phase. Follow-up phase is 12 weeks.
The PSFS is a patient reported, individualized measure in which patients nominate two activities and rate difficulty on an 11 point scale (0-10); higher scores reflect better function. Test-retest reliability across musculoskeletal conditions (e.g., ICC ≈0.82-0.97) is reported good to excellent. Construct/concurrent validity is supported via correlations with the RMQ, NDI, and SF 36, and predictive validity for return to work outcomes.
SecondaryChange on the Numeric Pain Rating Scale (NPRS) from phase A to phase B to follow-up.At start of baseline, after 3 weeks and 6 weeks of treatment and at the end of the follow-up phase. Follow-up phase is 12 weeks.
The NPRS is a unidimensional self report of pain intensity, typically using 0-10 anchors ("no pain" to "pain as bad as you can imagine"). Scores generally correspond to VAS, though not perfectly interchangeable. The NPRS is widely used in pain research and its psychometric characteristics are reported to be good.
OtherChange in subjective norms from phase A to phase B to follow-up.At start of baseline, after 3 weeks and 6 weeks of treatment and at the end of the follow-up phase. Follow-up phase is 12 weeks.
Subjective norms are part of the Theory of Planned Behaviour construct and will be measured as a moderator. Description: BCIO: Perceived evaluative behavioral norm (BCIO:006041) Definition: A \<perceived norm\> regarding whether a behaviour is appropriate and correct for people who belong to a particular group. https://bciosearch.org/BCIO\_006041 Subjective norms will be measured with a single item (m-Path mobile application). Question: "People in my environment consider it important to engage in 2.5 hours of moderately intensive physical activity per week." (strongly disagree(0) - strongly agree(100))
OtherChange in attitude towards physical activity from phase A to phase B to follow-up.Twice a week during Phase A and B. One time at the end of the follow-up phase(Phase A'). Follow-up phase is 12 weeks.
Attitude towards the behaviour is part of the Theory of Planned Behaviour construct and will be measured as a mediator. BCIO: Attitude towards a behaviour (BCIO:050329) Definition: An \<attitude\> in which the entity that is the attitude object is a behaviour. https://bciosearch.org/BCIO\_050329 Attitude towards physical activity will be measured with a single item (m-Path mobile application). Question: "For me, 2.5 hours per week of moderately intensive physical activity is…" (not important(0)-very important(100))
OtherChange in perceived controllability of physical activity levels from phase A to phase B to follow-up.Daily measurements twice a day during Phase A and B (7-8 weeks). Also twice a day during the last 5 days of the follow-up phase (Phase A'). Follow-up phase is 12 weeks.
Perceived controllability is part of the Theory of Planned Behaviour construct and will be measured as a mediator. Description: BCIO: Belief about control over behaviour (BCIO:006152)\[Mv20.1\] Definition: A \<belief\> about one's capabilities and opportunities within an environmental system to perform a behaviour or achieve the outcomes resulting from a behaviour. https://bciosearch.org/BCIO\_006152 Perceived controllability will be measured with a single item (m-Path mobile application). Question: "I currently have control over how physically active I am." (strongly disagree(0) - strongly agree(100))
OtherChange in intention from phase A to phase B to follow-up.Daily measurements twice a day during Phase A and B (7-8 weeks). Also twice a day during the last 5 days of the follow-up phase (Phase A'). Follow-up phase is 12 weeks.
Intention is part of the Theory of Planned Behaviour construct and will be measured as a mediator. Description: BCIO: Behavioral intention (BCIO:006016) Definition: A \<mental disposition\> to commit to enact or not enact a behaviour. https://bciosearch.org/BCIO\_006016 Intention will be measured with a single item (m-Path mobile application). Question: "I will be physically active within the next few hours." (strongly disagree (0) - strongly agree(100))

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07901881

GET https://conductscience.org/api/trials/v1/NCT07901881/registered