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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283186
• Other study ID #: CSEULS-PI-004/2024
• Status: Recruiting
• Phase: Phase 1
• Start date: April 23, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Centro Universitario La Salle
• Contact: Álvaro Reina-Varona, MSc
• Phone: 0034+649001863
• Email: alvaro.reina[@]lasallecampus.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Spain	CSEU LaSalle	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)