Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT07302204

Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis

Led by University of Nove de Julho · Updated on 2026-04-02

90

Participants Needed

2

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 45 to 75 years
  • Clinical diagnosis of symptomatic knee osteoarthritis for at least 3 months
  • Knee pain for more than 3 months with average pain intensity 3 or higher on a 0 to 10 scale
  • Morning stiffness lasting less than 30 minutes
  • Clinical signs of knee osteoarthritis such as crepitus, bony tenderness, and no palpable warmth at the knee
Not Eligible

You will not qualify if you...

  • Main source of pain is the hip
  • Osteoporosis
  • Fibromyalgia
  • History of tumors or cancer
  • Active inflammatory joint diseases such as rheumatoid arthritis or gout
  • Previous joint replacement surgery of any lower limb joint
  • Neurological diseases including Parkinson's, stroke, multiple sclerosis, muscular dystrophy, motor neuron disease, or Alzheimer's disease
  • Cardiovascular diseases that prevent safe exercise
  • Infected wounds or osteomyelitis near the knee
  • Deep vein thrombosis or thrombophlebitis
  • Sensory problems in the lower limbs
  • Cognitive or heart/lung impairments limiting safe exercise participation
  • Use of walking aids
  • Recent knee injury

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Cid André Fidelis de Paula Gomes

São Paulo, Brazil, 01415000

Not Yet Recruiting

2

Nove de Julho University

São Paulo, Brazil, 01504-001

Actively Recruiting

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Research Team

C

Cid Gomes, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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