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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Aerobic exercise; Other: Aerobic exercise

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Álvaro Reina-Varona, MSc; Phone Number: 0034+649001863; Email: alvaro.reina@lasallecampus.es

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Recruiting
    • CSEU LaSalle
    • Contact: Álvaro Reina-Varona, MSc; Phone Number: 0034 + 649001863; Email: alvaroreina93@gmail.com
    • Principal Investigator: Álvaro Reina-Varona, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower limb cycle ergometer; The participants in the lower limb cycle ergometer group will undergo a 30-minute aerobic exercise intervention comprising a 5-minute warm-up, 20 minutes of training at 70-80% of the heart rate reserve, and a 5-minute cool-down.	Other: Aerobic exercise; Aerobic exercise with lower limb cycle ergometer; Other: Aerobic exercise; Aerobic exercise with upper limb cycle ergometer
Experimental: Upper limb cycle ergometer; The participants in the upper limb cycle ergometer group will undergo a 30-minute aerobic exercise intervention comprising a 5-minute warm-up, 20 minutes of training at 70-80% of the heart rate reserve, and a 5-minute cool-down.	Other: Aerobic exercise; Aerobic exercise with lower limb cycle ergometer; Other: Aerobic exercise; Aerobic exercise with upper limb cycle ergometer
No Intervention: Control; Participants in the control group will remain seated for the entire 30-minute duration of the experiment without receiving any form of distraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Three measurementes: before, immediately after intervention, and 30 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before intervention (up 5 minutes)
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.	Before intervention (up 5 minutes)
Heart rate	Heart rate will be measured during the procedure by a Polar H10 sensor and a Polar Ignate WR 30M watch.	During intervention (up 30 minutes)
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.	Immediately after intervention (up 10 seconds)
Physical Activity Readiness Questionnaire (PAR-Q)	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.	Before intervention (up 5 minutes)

Collaborators and Investigators

• Sponsor: Centro Universitario La Salle

Study record dates

Study Major Dates

• Study Start (Estimated): April 23, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Local Hypoalgesia; Distal Hypoalgesia; Pressure Pain Thresholds
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hypesthesia
• Other Study ID Numbers: CSEULS-PI-004/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No