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临床试验/NCT06283186
NCT06283186招募中1 期

Differences in Exercise-Induced Hypoalgesia at Local and Distal Levels Using Lower and Upper Limb Cycle Ergometer Protocols: A Randomized Controlled Trial in Healthy Participants

Centro Universitario La Salle2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月23日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
90
试验地点
2
主要终点
Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle

研究概览

简要总结

This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.

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
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic subjects aged between 18 and 64 years.

排除标准

  • Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
  • History of epilepsy.
  • Pharmacological treatment.
  • Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.

结局指标

主要结局

Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle

时间窗: Three measurementes: before, immediately after intervention, and 30 minutes after intervention

PPT is tested on the muscle belly of the quadriceps on the dominant side, 10 centimeters cranial to the superior pole of the patella, and on the muscle belly of the epicondyle muscles on the dominant side, 5 centimeters caudal to the epicondyle. The region to be pressed is marked with a pen. The patient is instructed to report the first appearance of the sensation of "discomfort". An ascending ramp of 0.5 kg/cm/s is applied, at the rhythm of a metronome. The measurement is started on the quadriceps and alternated with the epicondyle until 3 measurements of each region are obtained. Each measurement in the same region is obtained after 30 seconds of rest. This protocol has demonstrated high inter-observer reliability measuring healthy subjects (ICC = 0.91).

次要结局

  • International Physical Activity Questionnaire (IPAQ)(Before intervention (up 5 minutes))
  • Heart rate(During intervention (up 30 minutes))
  • Rate of perceived exertion (RPE)(Immediately after intervention (up 10 seconds))
  • Physical Activity Readiness Questionnaire (PAR-Q)(Before intervention (up 5 minutes))
  • Fatigue Assessment Scale (FAS)(Before intervention (up 5 minutes))

研究者

发起方
Centro Universitario La Salle
申办方类型
Other
责任方
Principal Investigator
主要研究者

Álvaro Reina Varona

Principal Investigator

Centro Universitario La Salle

研究点 (2)

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