Osteoarthritis of the KneeNCT07302204
Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis
A study testing Aerobic Exercise and Therapeutic Exercise in people with Osteoarthritis of the Knee, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Aerobic Exercise and Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Feb 2026to 20 Dec 2029
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of symptomatic knee osteoarthritis for at least 3 months.
- Report of knee pain for more than 3 months and average knee pain intensity ≥ 3 on the 0 to 10 Numeric Rating Scale.
- Morning stiffness lasting less than 30 minutes.
- Clinical signs compatible with knee osteoarthritis. crepitus, bony tenderness and absence of palpable warmth at the knee.
- Altered exercise-induced hypoalgesia: absence of exercise-induced hypoalgesia and hyperalgesic response to exercise.
Who cannot join
- Signs and symptoms indicating the hip as the main source of pain.
- Osteoporosis
- Fibromyalgia
- History of tumors or cancer
- Active inflammatory joint diseases, such as rheumatoid arthritis or gout.
- Previous arthroplasty of any lower limb joint.
Show all 14Show fewer
- Neurological diseases, including Parkinson's disease, stroke, multiple sclerosis, muscular dystrophy, motor neuron disease or Alzheimer's disease.
- Cardiovascular diseases for which exercise is formally contraindicated.
- Infected wounds or osteomyelitis in the knee region.
- Deep vein thrombosis or thrombophlebitis.
- Sensory alterations in the lower limbs.
- Cognitive or cardiopulmonary impairments that limit safe participation in the exercise program.
- Use of walking aids.
- Recent knee trauma.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Cid André Fidelis de Paula Gomes
São Paulo, 01415000
Cid Andre F Gomes, Phd, cid.andre@gmail.com
- Recruiting
Nove de Julho University
São Paulo, 01504-001
Cid Gomes
Cid Gomes, Phd
About this study
Official title: Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial
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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Aerobic Exercise, Therapeutic Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Supervised cycling on an electromagnetic recumbent stationary bicycle three times per week for ten weeks, with at least 24 hours between sessions.
Therapeutic ExerciseOther
Individually supervised, land based therapeutic exercise program focusing on warm up, resisted strengthening, neuromuscular training, mobility and balance.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group (AEG) | Experimental | 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. Receives: Other: Aerobic Exercise |
| Therapeutic Exercise Group (TEG) | Active comparator | 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. Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At weeks 1, 4, 7, and 10 of the 10 week intervention (within session, pre and immediately post exercise).
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 10 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start20 Feb 2026
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302204
- Sponsor's protocol ID
- 93560425.7.0000.5511
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07302204
- Acronym / sponsor ID
- 93560425.7.0000.5511
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 24 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group (AEG) | Experimental | Other: Aerobic ExerciseParticipants 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. |
| Therapeutic Exercise Group (TEG) | Active comparator | Other: Therapeutic ExerciseParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of symptomatic knee osteoarthritis for at least 3 months.
- Report of knee pain for more than 3 months and average knee pain intensity ≥ 3 on the 0 to 10 Numeric Rating Scale.
- Morning stiffness lasting less than 30 minutes.
- Clinical signs compatible with knee osteoarthritis. crepitus, bony tenderness and absence of palpable warmth at the knee.
- Altered exercise-induced hypoalgesia: absence of exercise-induced hypoalgesia and hyperalgesic response to exercise.
Key exclusion criteria (14 listed)
- Signs and symptoms indicating the hip as the main source of pain.
- Osteoporosis
- Fibromyalgia
- History of tumors or cancer
- Active inflammatory joint diseases, such as rheumatoid arthritis or gout.
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 |
|---|---|---|
| Aerobic ExerciseSupervised cycling on an electromagnetic recumbent stationary bicycle three times per week for ten weeks, with at least 24 hours between sessions. | Other | Aerobic Exercise Group (AEG) |
| Therapeutic ExerciseIndividually supervised, land based therapeutic exercise program focusing on warm up, resisted strengthening, neuromuscular training, mobility and balance. | Other | Therapeutic Exercise Group (TEG) |
Primary outcome
Exercise-induced hypoalgesia (EIH)
Time frame: At weeks 1, 4, 7, and 10 of the 10 week intervention (within session, pre and immediately post exercise).
exercise induced hypoalgesia (EIH) of the medial compartment of the knees, measured by the change in pressure pain threshold (Δ PPT)
13 secondary outcomes
Exercise induced hypoalgesia of the quadriceps
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
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
Time frame: Baseline and after 10 weeks of intervention.
Conditioned pain modulation
Time frame: Baseline and after 10 weeks of intervention.
Pain intensity
Time frame: Baseline and after 10 weeks of intervention.
Pain self efficacy
Time frame: Baseline and after 10 weeks of intervention.
Knee related health status
Time frame: Baseline and after 10 weeks of intervention.
Patient specific functional status
Time frame: Baseline and after 10 weeks of intervention.
Functional performance, thirty second sit to stand test
Time frame: Baseline and after 10 weeks of intervention.
Quadriceps muscle strength
Time frame: Baseline and after 10 weeks of intervention.
Global perceived effect
Time frame: After 10 weeks of intervention.
Adherence to the intervention
Time frame: Throughout the 10 week intervention period.
Physical activity enjoyment
Time frame: After 10 weeks of intervention.
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 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of the Knee
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Therapeutic Exercise in people with Osteoarthritis of the Knee, run by University of Nove de Julho at 2 sites in Brazil.
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 14 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 Cid Gomes, Phd (+5511970941936, cid.andre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise-induced hypoalgesia (EIH) (time frame: At weeks 1, 4, 7, and 10 of the 10 week intervention (within session, pre and immediately post exercise).). 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 25 Jun 2026.