Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Exercise-induced hypoalgesia (EIH)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Aerobic Exercise Group (AEG)
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.
干预措施: Aerobic Exercise (Other)
Therapeutic Exercise Group (TEG)
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.
干预措施: Therapeutic Exercise (Other)
结局指标
主要结局
Exercise-induced hypoalgesia (EIH)
时间窗: 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)
次要结局
- Exercise induced hypoalgesia of the quadriceps(Within session, immediately before and immediately after the exercise session at weeks 1, 4, 7, and 10 of the 10 week intervention.)
- Adherence to the intervention(Throughout the 10 week intervention period.)
- Exercise induced hypoalgesia of the upper trapezius(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(Baseline and after 10 weeks of intervention.)
- Conditioned pain modulation(Baseline and after 10 weeks of intervention.)
- Pain self efficacy(Baseline and after 10 weeks of intervention.)
- Knee related health status(Baseline and after 10 weeks of intervention.)
- Patient specific functional status(Baseline and after 10 weeks of intervention.)
- Functional performance, thirty second sit to stand test(Baseline and after 10 weeks of intervention.)
- Quadriceps muscle strength(Baseline and after 10 weeks of intervention.)
- Global perceived effect(After 10 weeks of intervention.)
- Exercise induced hypoalgesia of the quadriceps(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, 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(Baseline and after 10 weeks of intervention.)
- Conditioned pain modulation(Baseline and after 10 weeks of intervention.)
- Pain intensity(Baseline and after 10 weeks of intervention.)
- Pain self efficacy(Baseline and after 10 weeks of intervention.)
- Knee related health status(Baseline and after 10 weeks of intervention.)
- Patient specific functional status(Baseline and after 10 weeks of intervention.)
- Functional performance, thirty second sit to stand test(Baseline and after 10 weeks of intervention.)
- Quadriceps muscle strength(Baseline and after 10 weeks of intervention.)
- Global perceived effect(After 10 weeks of intervention.)
- Adherence to the intervention(Throughout the 10 week intervention period.)
研究者
Cid André Fidelis de Paula Gomes
Professor Phd
University of Nove de Julho