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Recruiting NCT06283186

Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals

Phase I Interventional Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise, Aerobic exercise.
Who it may be relevant to
Registry conditions: Healthy Subjects. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Aerobic exercise
    Aerobic exercise with lower limb cycle ergometer
  • Other Aerobic exercise
    Aerobic exercise with upper limb cycle ergometer

Primary outcome measures

  • Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle [Time frame: Three measurementes: before, immediately after intervention, and 30 minutes after intervention]
Secondary outcome measures (5)
  • International Physical Activity Questionnaire (IPAQ) [Time frame: Before intervention (up 5 minutes)]
  • Fatigue Assessment Scale (FAS) [Time frame: Before intervention (up 5 minutes)]
  • Heart rate [Time frame: During intervention (up 30 minutes)]
  • Rate of perceived exertion (RPE) [Time frame: Immediately after intervention (up 10 seconds)]
  • Physical Activity Readiness Questionnaire (PAR-Q) [Time frame: Before intervention (up 5 minutes)]

Eligibility criteria

Inclusion criteria

  • Asymptomatic subjects aged between 18 and 64 years.

Exclusion criteria

  • Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
  • History of epilepsy.
  • Pregnant
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • CSEU LaSalle — Madrid

Identifiers

NCT: NCT06283186 · CSEULS-PI-004/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗