Local HypoalgesiaNCT06765486
Exercise-Induced Hypoalgesia Differences Between Upper and Lower Limbs Resistance Training Interventions
A study testing Lower limb resistance training and Upper limb resistance training in people with Local Hypoalgesia and Distal Hypoalgesia, run by Centro Universitario La Salle at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Hypoalgesia, Distal Hypoalgesia, Resistance Training
- What is being tested?
- Lower limb resistance training and Upper limb resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects aged between 18 and 64 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
CSEU LaSalle
Madrid, 28023
Álvaro Reina-Varona, MSc, (+34) 91 740 19 80, alvaro.reina@lasallecampus.es
Álvaro Reina-Varona, MSc
About this study
Official title: 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
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.
- Being tested
- Lower limb resistance training, Upper limb resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb resistance trainingOther
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.
Upper limb resistance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before, immediately after intervention, and 30 minutes after intervention.
Secondary outcomes (4)
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
Measured: before intervention (up 5 minutes)
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.
Measured: before intervention (up 5 minutes)
Fatigue Assessment Scale (FAS)
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.
Measured: before intervention (up 5 minutes)
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. Higher scores indicate a higher perception of effort.
Measured: immediately after intervention (up 10 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start15 Feb 2025
- Primary completion20 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local HypoalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Álvaro Reina Varona, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765486
- Sponsor's protocol ID
- CSEULS-PI-013
- Status last verified
- Feb 2025
- First submitted
- 3 Jan 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06765486
- Acronym / sponsor ID
- CSEULS-PI-013
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lower limb resistance training | Experimental | Other: Lower limb resistance trainingThe 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). |
| Upper limb resistance training | Experimental | Other: Upper limb resistance trainingThe 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. |
| Control | No intervention | –Participants in the control group will remain seated for the entire duration of the experiment without receiving any form of distraction. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects aged between 18 and 64 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower limb resistance trainingExercise 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. | Other | Lower limb resistance training |
| Upper limb resistance trainingExercise 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. | Other | Upper limb resistance training |
Primary outcome
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).
4 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: before intervention (up 5 minutes)
Physical Activity Readiness Questionnaire (PAR-Q)
Time frame: before intervention (up 5 minutes)
Fatigue Assessment Scale (FAS)
Time frame: before intervention (up 5 minutes)
Rate of perceived exertion (RPE)
Time frame: immediately after intervention (up 10 seconds)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Local Hypoalgesia
RecruitingPhase 1
Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals
Healthy Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower limb resistance training and Upper limb resistance training in people with Local Hypoalgesia and Distal Hypoalgesia, run by Centro Universitario La Salle at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Álvaro Reina-Varona, MSc ((+34) 91 740 19 80 ext. 506, alvaro.reina@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (PPT) on dominant quadriceps and dominant brachial biceps (time frame: before, immediately after intervention, and 30 minutes after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.