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NCT Number: NCT06283186

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

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CSEU LaSalle

Madrid, 28023, Spain

Location status: Recruiting

Location contact

Álvaro Reina-Varona, MSc

CONTACT

[email protected]

0034 + 649001863

Álvaro Reina-Varona, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Other

Aerobic exercise with lower limb cycle ergometer

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. International Physical Activity Questionnaire (IPAQ)

    Time frame: Before intervention (up 5 minutes)

    7-item questionnaire on the level of physical activity at different intensities (high, moderate, and low) and hours sitting. A higher score means higher weekly physical activity.

  2. Fatigue Assessment Scale (FAS)

    Time frame: Before intervention (up 5 minutes)

    10-item questionnaire that allows for the evaluation of the participant's current level of fatigue. A higher score means higher fatigue.

  3. Heart rate

    Time frame: During intervention (up 30 minutes)

    Heart rate will be measured during the procedure by a Polar H10 sensor and a Polar Ignate WR 30M watch.

  4. Rate of perceived exertion (RPE)

    Time frame: Immediately after intervention (up 10 seconds)

    RPE Borg CR-10 is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes.

  5. Physical Activity Readiness Questionnaire (PAR-Q)

    Time frame: Before intervention (up 5 minutes)

    7-item questionnaire that assesses an individual's readiness to engage in physical activity based on whether any known contraindications have been ruled out by the participant. If all the questions are negative, the participant can safely engage in a physical activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Álvaro Reina-Varona, MSc

CONTACT

[email protected]

0034+649001863

Sponsors and collaborators

Lead sponsor

Centro Universitario La Salle

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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