- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765486
Exercise-Induced Hypoalgesia Differences Between Upper and Lower Limbs Resistance Training Interventions
Exercise-Induced Hypoalgesia Differences at Proximal and Distal Regions After Applying a Lower Limb Resistance Training or an Upper Limb Resistance Training Protocol: A Randomized Controlled Trial in Healthy Participants
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Álvaro Reina-Varona, MSc
- Phone Number: 506 (+34) 91 740 19 80
- Email: alvaro.reina@lasallecampus.es
Study Locations
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-
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Madrid, Spain, 28023
- Recruiting
- CSEU LaSalle
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Principal Investigator:
- Álvaro Reina-Varona, MSc
-
Contact:
- Álvaro Reina-Varona, MSc
- Phone Number: (+34) 91 740 19 80
- Email: alvaro.reina@lasallecampus.es
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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.
- 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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lower limb resistance training
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).
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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.
|
|
Experimental: Upper limb resistance training
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.
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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.
|
|
No Intervention: Control
Participants in the control group will remain seated for the entire duration of the experiment without receiving any form of distraction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain pressure threshold (PPT) on dominant quadriceps and dominant brachial biceps
Time Frame: before, immediately after intervention, and 30 minutes after intervention.
|
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).
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before, immediately after intervention, and 30 minutes after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ)
Time Frame: before intervention (up 5 minutes)
|
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)
|
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Physical Activity Readiness Questionnaire (PAR-Q)
Time Frame: before intervention (up 5 minutes)
|
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)
|
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Fatigue Assessment Scale (FAS)
Time Frame: before intervention (up 5 minutes)
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10-item questionnaire that allows for the evaluation of the participant's current level of fatigue. This instrument measures 10 to 50 points. A higher score means higher fatigue. |
before intervention (up 5 minutes)
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Rate of perceived exertion (RPE)
Time Frame: immediately after intervention (up 10 seconds)
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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.
Higher scores indicate a higher perception of effort.
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immediately after intervention (up 10 seconds)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEULS-PI-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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