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

NCT ID: NCT06283186

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

Aerobic exercise with lower limb cycle ergometer

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.

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

Aerobic exercise with upper limb cycle ergometer

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic exercise

Aerobic exercise with lower limb cycle ergometer

Intervention Type OTHER

Aerobic exercise

Aerobic exercise with upper limb cycle ergometer

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Universitario La Salle

OTHER

Sponsor Role lead

Responsible Party

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Álvaro Reina Varona

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CSEU LaSalle

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Álvaro Reina-Varona, MSc

Role: CONTACT

0034+649001863

Facility Contacts

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Álvaro Reina-Varona, MSc

Role: primary

0034 + 649001863

Other Identifiers

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CSEULS-PI-004/2024

Identifier Type: -

Identifier Source: org_study_id

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