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

NCT06283186 | Recruiting Phase 1

• 1 other identifier: CSEULS-PI-004/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

Local Hypoalgesia; Distal Hypoalgesia; Aerobic Exercise; Pressure Pain Thresholds

Outcome Measures

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).

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

Secondary Outcomes (5)

• International Physical Activity Questionnaire (IPAQ)

  Before intervention (up 5 minutes)

• Fatigue Assessment Scale (FAS)

  Before intervention (up 5 minutes)

• Heart rate

  During intervention (up 30 minutes)

• Rate of perceived exertion (RPE)

  Immediately after intervention (up 10 seconds)

• Physical Activity Readiness Questionnaire (PAR-Q)

  Before intervention (up 5 minutes)

Study Arms (3)

Lower limb cycle ergometer

EXPERIMENTAL

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

Upper limb cycle ergometer

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the control group will remain seated for the entire 30-minute duration of the experiment without receiving any form of distraction.

Interventions

Aerobic exercise OTHER

Aerobic exercise with lower limb cycle ergometer

Lower limb cycle ergometer

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Asymptomatic subjects aged between 18 and 64 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

CSEU LaSalle

Madrid, 28023, Spain

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Álvaro Reina-Varona, MSc

CONTACT

0034+649001863; alvaro.reina@lasallecampus.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: April 23, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)