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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorCentro Universitario La Salle

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Asymptomatic subjects aged between 18 and 64 years.

Disqualifiers

Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.

History of epilepsy.

Pregnant

Pharmacological treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic exercise

    Other intervention

    Aerobic exercise with lower limb cycle ergometer

  • Aerobic exercise

    Other intervention

    Aerobic exercise with upper limb cycle ergometer

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Lower limb cycle ergometerExperimental treatment 1 intervention
Group B: Upper limb cycle ergometerExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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).

Time frame
Three measurementes: before, immediately after intervention, and 30 minutes after intervention

Secondary outcomes

1

International Physical Activity Questionnaire (IPAQ)

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.

Time frame
Before intervention (up 5 minutes)
2

Fatigue Assessment Scale (FAS)

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

Time frame
Before intervention (up 5 minutes)
3

Heart rate

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

Time frame
During intervention (up 30 minutes)
4

Rate of perceived exertion (RPE)

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.

Time frame
Immediately after intervention (up 10 seconds)

Other outcomes

Sponsors and contacts

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