Aerobic cycling versus therapeutic exercise for knee osteoarthritis pain sensitivity
Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial
This trial tests whether aerobic cycling or a therapeutic exercise program better reduces exercise-related pain sensitivity in people aged 45–75 with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 2 sites (São Paulo and 1 other locations) |
| Trial ID | NCT07302204 on ClinicalTrials.gov |
What this trial studies
Ninety adults with symptomatic knee osteoarthritis will be randomized to one of two exercise programs delivered three times per week for ten weeks: aerobic exercise on a recumbent cycle ergometer with effort guided by the Borg scale, or a multi-component therapeutic program including resistance, neuromuscular, mobility, and balance exercises. The primary outcome is exercise-induced hypoalgesia, measured as within-session increases in pressure pain threshold at the knee across four anchor sessions during the 10-week program. Allocation will be concealed with opaque envelopes and the outcome assessor will be blinded to group assignment. Baseline and 10-week assessments will be performed to compare changes between groups.
Who should consider this trial
Good fit: Adults aged 45–75 with a clinical diagnosis of symptomatic knee osteoarthritis for at least 3 months, average knee pain ≥3/10, morning stiffness under 30 minutes, and clinical signs compatible with knee OA are the intended participants.
Not a fit: People with inflammatory arthritis, fibromyalgia, osteoporosis, prior lower-limb arthroplasty, neurological disease, cardiovascular contraindications to exercise, or hip-origin pain are unlikely to benefit or be eligible for this program.
Why it matters
Potential benefit: If successful, the results could identify which common exercise approach more quickly reduces pain sensitivity during and after exercise, helping clinicians tailor rehabilitation for people with knee osteoarthritis.
How similar studies have performed: Prior research shows that both aerobic and strengthening/therapeutic exercise programs can reduce pain in knee osteoarthritis, but direct comparisons focused on immediate exercise-induced hypoalgesia are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
São Paulo and 1 other locations
- Cid André Fidelis de Paula Gomes — São Paulo, Brazil (Not_yet_recruiting)
- Nove de Julho University — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Cid Gomes, Phd
- Email: cid.andre@gmail.com
- Phone: +5511970941936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.