NCT06765486

Brief Summary

This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb resistance training intervention, another using an upper limb resistance training, and a control group. The exercise protocol involves 3 sets of 5 repetitions of resistance exercises (brachial biceps curl and leg extensions). Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow, comparing exercise interventions with the control group. Additionally, a secondary objective is to compare the lower limb and upper limb resistance training 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

January 3, 2025

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain pressure threshold (PPT) on dominant quadriceps and dominant brachial biceps

    PPT is tested on the muscle belly of the quadriceps on the dominant side, at half of the distance between the anterior-superior iliac spine and the superior pole of the patella, and on the muscle belly of the brachial biceps on the dominant side, at a point one-fourth of the distance from the elbow crease to the lateral border of the acromion. 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 instrument measures 0 to 25 kg, with a higher score interpreted as a hypoalgesia response. The measurement is started on the quadriceps and alternated with the biceps 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).

    before, immediately after intervention, and 30 minutes after intervention.

Secondary Outcomes (4)

  • International Physical Activity Questionnaire (IPAQ)

    before intervention (up 5 minutes)

  • Physical Activity Readiness Questionnaire (PAR-Q)

    before intervention (up 5 minutes)

  • Fatigue Assessment Scale (FAS)

    before intervention (up 5 minutes)

  • Rate of perceived exertion (RPE)

    immediately after intervention (up 10 seconds)

Study Arms (3)

Lower limb resistance training

EXPERIMENTAL

The participants in the lower limb resistance training group will undergo 3 sets of 5 repetitions of leg extensions with the 5-resistance maximum (5RM), comprising a 5-minute warm-up in cycle ergometer at 1 watt per kg and 60-80 revolutions per minute and 1 set of 5 repetitions with the 10-resistance maximum (10RM).

Other: Lower limb resistance training

Upper limb resistance training

EXPERIMENTAL

The participants in the upper limb resistance training group will undergo 3 sets of 5 repetitions of brachial biceps curl with the 5RM, comprising a 5-minute warm-up in cycle ergometer at 1 watt per kg and 60-80 revolutions per minute and 1 set of 5 repetitions with the 10RM.

Other: Upper limb resistance training

Control

NO INTERVENTION

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

Interventions

Exercise intervention with leg extensions on the dominant quadriceps, doing 3 sets of 5 repetitions with the 5RM after a 5-minute warm-up with a cycle ergometer at 1 watt per kg and 60-80 revolutions per minute and 1 set of 5 repetitions with the 10RM. Previously, 72 hours before, the 5RM would have been calculated progressively approaching in sets of 5 repetitions, starting with the lower weight and stopping the test when obtaining an unsuccessful trial (the participant could not manage to lift the weight five times). The previous successful set would be established as the 5RM.

Lower limb resistance training

Exercise intervention with brachial biceps curl on the dominant brachial biceps, doing 3 sets of 5 repetitions with the 5RM after a 5-minute warm-up with a cycle ergometer at 1 watt per kg and 60-80 revolutions per minute and 1 set of 5 repetitions with the 10RM. Previously, 72 hours before, the 5RM would have been calculated progressively approaching in sets of 5 repetitions, starting with the lower weight and stopping the test when obtaining an unsuccessful trial (the participant could not manage to lift the weight five times). The previous successful set would be established as the 5RM.

Upper limb resistance training

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.
  • Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU LaSalle

Madrid, 28023, Spain

RECRUITING

Central Study Contacts

Álvaro Reina-Varona, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
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

January 3, 2025

First Posted

January 9, 2025

Study Start

February 15, 2025

Primary Completion

May 20, 2025

Study Completion

June 1, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations