An interventional study of Aerobic Exercise and Therapeutic Exercise in Osteoarthritis of the Knee, sponsored by University of Nove de Julho. Recruiting at 2 sites in Brazil. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
Among 79 studies in Osteoarthritis, Knee with a site in Brazil — 12 open to participants now, 13 under way, 2 of them phase 3. Osteoarthritis, Knee · Brazil.
Among the 79 studies in Osteoarthritis, Knee with a site in Brazil, this one is the 30th largest by planned enrollment of the 77 interventional ones that give a count, is one of 2 that started in 2026, is one of 50 with no phase, reaches primary completion later than 11 of the 12 other live ones, and was the 77th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →12 of the 79 studies in Osteoarthritis, Knee with a site in Brazil are open now. Recruiting first, the newest first:
University of Nove de Julho · Sites in Brazil
University of Nove de Julho · Sites in Brazil
University of Nove de Julho · Sites in Brazil
University of Nove de Julho · Sites in Brazil
University of Sao Paulo General Hospital · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 40 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8 · Phase 3 10 · Phase 4 9
First in 2005; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 90 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 70 across the 77 interventional studies, 38 across the 2 observational. Of the 48 that completed or were terminated, 7 (15%) have results posted.
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9 of 79 have an industry lead sponsor. The 10 most frequent:
University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
University of Nove de Julho has 8 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
2 of the studies in Osteoarthritis, Knee with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06187038University of Nove de JulhoEffects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA | 2026-11-30 |
| NCT06905860Federal University of São PauloIntra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis | 2027-06-01 |
Among the 79 studies in Osteoarthritis, Knee with a site in Brazil, from their registry updates:
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The study compares two exercise strategies in people with knee osteoarthritis. The first is aerobic exercise on a recumbent cycle ergometer, with effort controlled by the Borg scale. The second is a therapeutic exercise program with resistance, neuromuscular, mobility, and balance components. The primary objective is to determine which approach produces greater exercise induced hypoalgesia, measured by the increase in pressure pain threshold at the knee within the session across four anchor sessions during a ten week program. This is a randomized clinical trial with two parallel arms. Ninety participants, between forty five and seventy five years of age, will be allocated to one of the two groups. Allocation sequence concealment will be ensured using opaque envelopes. The outcome assessor will remain blinded to group allocation. The interventions will take place three times per week for ten weeks. Assessments will be performed at baseline and after ten weeks. Within session measurements will also be taken in weeks one, four, seven, and ten. The primary outcome is the intra session change in pressure pain threshold at the medial compartment of the knee. Secondary outcomes include exercise induced hypoalgesia in the quadriceps and trapezius, chronic adaptation of pressure pain threshold, conditioned pain modulation, pain intensity, pain self efficacy, knee related health status, functional performance, quadriceps strength, global perceived effect, and adherence. The planned sample size is forty five participants per group. The analysis will follow the intention to treat principle. The primary outcome will be compared using linear mixed models with group and time effects. Clinical outcomes at T1 will be adjusted for baseline values. Estimates, confidence intervals, and interpretation in light of minimally important differences will be reported.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to the Aerobic Exercise Group (AEG) will perform supervised cycling on an electromagnetic recumbent stationary bicycle three times per week for ten weeks, with at least 24 hours between sessions. Each session will be structured as five minutes of warm up, a progressively longer work phase, and five minutes of cool down. Exercise intensity will be prescribed and monitored using the 6 to 20 Borg Rating of Perceived Exertion scale, targeting light to moderate exertion during warm up and cool down and moderate to somewhat hard exertion during the work phase. Cadence will be maintained around 60 to 80 revolutions per minute and the resistance level will be adjusted to keep participants within the target exertion zone.
Other: Aerobic Exercise
Participants allocated to the Therapeutic Exercise Group will receive an individually supervised, land based therapeutic exercise program focusing on warm up, resisted strengthening, neuromuscular training, mobility and balance. Sessions will be performed three times per week for ten weeks, with at least 24 hours between sessions, and will last approximately 60 minutes. Therapeutic exercises will be completed in up to three sets of 8 to 12 repetitions in weeks 1 to 5 and 8 to 15 repetitions in weeks 6 to 10, each set lasting 30 to 60 seconds, with 90 second rest intervals between sets. Load for machine or free weight exercises will be prescribed at about 40 to 60 percent of the pain limited one repetition maximum, elastic band resistance will be set to allow 12 repetitions with pain ≤ 5 out of 10, and body weight exercises will be held for 30 to 60 seconds. Vital signs and knee pain intensity will be assessed before, during and after each session to guide safety and progression.
Other: Therapeutic Exercise
Supervised cycling on an electromagnetic recumbent stationary bicycle three times per week for ten weeks, with at least 24 hours between sessions.
Individually supervised, land based therapeutic exercise program focusing on warm up, resisted strengthening, neuromuscular training, mobility and balance.
Exercise-induced hypoalgesia (EIH)
exercise induced hypoalgesia (EIH) of the medial compartment of the knees, measured by the change in pressure pain threshold (Δ PPT)
Time frame: At weeks 1, 4, 7, and 10 of the 10 week intervention (within session, pre and immediately post exercise).
Exercise induced hypoalgesia of the quadriceps
Within session change in pressure pain threshold at the rectus femoris muscle, calculated as post exercise minus pre exercise values and averaged bilaterally, measured with a digital algometer and expressed in kilograms force per square centimeter.
Time frame: Within session, immediately before and immediately after the exercise session at weeks 1, 4, 7, and 10 of the 10 week intervention.
Exercise induced hypoalgesia of the upper trapezius
Within session change in pressure pain threshold at the upper trapezius muscle descending portion, calculated as post exercise minus pre exercise values and averaged bilaterally, measured with a digital algometer and expressed in kilograms force per square centimeter.
Time frame: Within session, immediately before and immediately after the exercise session at weeks 1, 4, 7, and 10 of the 10 week intervention.
Chronic adaptation of pressure pain threshold
Change in pressure pain threshold at the medial compartment of the knee, rectus femoris and upper trapezius between baseline and post intervention, averaged bilaterally and expressed in kilograms force per square centimeter.
Time frame: Baseline and after 10 weeks of intervention.
Conditioned pain modulation
Change in the conditioned pain modulation effect assessed by a standardized conditioned pain modulation test, defined as the change in pressure pain threshold at the volar forearm during and after an ischemic conditioning stimulus on the contralateral arm, with pain intensity standardized around four out of ten on a numeric rating scale.
Time frame: Baseline and after 10 weeks of intervention.
Pain intensity
Average knee pain intensity over the past seven days at rest and after movement, measured on an eleven-point numeric rating scale from zero (no pain) to ten (worst imaginable pain). Numeric Rating Scale for Pain Intensity. Range 0 to 10, with 0 indicating no pain and 10 the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame: Baseline and after 10 weeks of intervention.
Pain self efficacy
Pain Self Efficacy Questionnaire. Ten items scored 0 to 6 each, total score 0 to 60. Higher scores indicate better outcome, greater pain related self efficacy.
Time frame: Baseline and after 10 weeks of intervention.
Knee related health status
Knee Injury and Osteoarthritis Outcome Score. Subscales are transformed to a 0 to 100 score, where 0 represents the worst knee health status and 100 the best. Higher scores indicate better outcome, better knee related health status.
Time frame: Baseline and after 10 weeks of intervention.
Patient specific functional status
Patient Specific Functional Scale. Each selected activity is rated from 0 to 10, where 0 means unable to perform the activity and 10 means able to perform as before the problem. The total score is the mean of the three activities, range 0 to 10. Higher scores indicate better outcome, better patient specific functional status.
Time frame: Baseline and after 10 weeks of intervention.
Functional performance, thirty second sit to stand test
Number of full sit to stand repetitions completed from a standard height chair in thirty seconds, higher counts reflecting better lower limb strength, dynamic balance and functional performance.
Time frame: Baseline and after 10 weeks of intervention.
Quadriceps muscle strength
Maximal voluntary isometric contraction of the quadriceps measured with a handheld dynamometer in a standardized seated position, normalized to body mass and expressed as a percentage, with higher values indicating greater strength.
Time frame: Baseline and after 10 weeks of intervention.
Global perceived effect
Global Perceived Effect scale. Eleven point scale ranging from minus 5, much worse, to 0, no change, to plus 5, completely recovered. Higher scores indicate better outcome, greater perceived recovery.
Time frame: After 10 weeks of intervention.
Adherence to the intervention
Proportion of attended exercise sessions relative to the thirty planned sessions, calculated as attendance percentage sessions attended divided by sessions planned multiplied by one hundred.
Time frame: Throughout the 10 week intervention period.
Physical activity enjoyment
Perceived enjoyment during physical activity or exercise, assessed using the Brazilian Portuguese version of the Physical Activity Enjoyment Scale (PACES). The PACES includes 18 items answered on a 7 point bipolar scale, in which participants indicate how they felt about the exercise session just completed. Scores will be calculated according to the item recoding instructions of the instrument, with higher scores indicating greater perceived enjoyment of physical activity.
Time frame: After 10 weeks of intervention.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2029, 46 months after the start.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 46 months is above that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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