Healthy SubjectsPhase 1NCT06283186
Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals
A Phase 1 study testing Aerobic exercise in people with Healthy Subjects, 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 cycle ergometer, another using an upper limb cycle ergometer, 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
- Healthy Subjects
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 23 Apr 2024to 31 Jul 2025
- Phase
- Phase 1
- 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
- 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.
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, 0034 + 649001863, alvaroreina93@gmail.com
Álvaro Reina-Varona, MSc
About this study
Official title: Differences in Exercise-Induced Hypoalgesia at Local and Distal Levels Using Lower and Upper Limb Cycle Ergometer Protocols: 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 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
- Being tested
- Aerobic exercise
- Keywords
- Local Hypoalgesia, Distal Hypoalgesia, Aerobic Exercise, Pressure Pain Thresholds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Aerobic exercise with lower limb cycle ergometer
Aerobic exerciseOther
Aerobic exercise with upper limb cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Three measurementes: before, immediately after intervention, and 30 minutes after intervention
Secondary outcomes (5)
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)
Fatigue Assessment Scale (FAS)
10-item questionnaire that allows for the evaluation of the participant's current level of fatigue. A higher score means higher fatigue.
Measured: Before intervention (up 5 minutes)
Heart rate
Heart rate will be measured during the procedure by a Polar H10 sensor and a Polar Ignate WR 30M watch.
Measured: During intervention (up 30 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.
Measured: Immediately after intervention (up 10 seconds)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Apr 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 1
- 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
- NCT06283186
- Sponsor's protocol ID
- CSEULS-PI-004/2024
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2024
- Last updated
- 27 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Exercise-Induced Hypoalgesia at Local and Distal Levels Using Lower and Upper Limb Cycle Ergometer Protocols: A Randomized Controlled Trial in Healthy Participants
- ClinicalTrials.gov ID
- NCT06283186
- Acronym / sponsor ID
- CSEULS-PI-004/2024
- Conditions
- Healthy Subjects
- Keywords
- Local Hypoalgesia, Distal Hypoalgesia, Aerobic Exercise, Pressure Pain Thresholds
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Feb 2024 (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 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.
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 cycle ergometer | Experimental | Other: Aerobic exerciseThe 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. |
| Upper limb cycle ergometer | Experimental | Other: Aerobic exerciseThe 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. |
| 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. |
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 (5 listed)
- 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.
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 |
|---|---|---|
| Aerobic exerciseAerobic exercise with lower limb cycle ergometer | Other | Lower limb cycle ergometer |
| Aerobic exerciseAerobic exercise with upper limb cycle ergometer | Other | Upper limb cycle ergometer |
Primary outcome
Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle
Time frame: Three measurementes: before, immediately after intervention, and 30 minutes after intervention
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).
5 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: Before intervention (up 5 minutes)
Fatigue Assessment Scale (FAS)
Time frame: Before intervention (up 5 minutes)
Heart rate
Time frame: During intervention (up 30 minutes)
Rate of perceived exertion (RPE)
Time frame: Immediately after intervention (up 10 seconds)
Physical Activity Readiness Questionnaire (PAR-Q)
Time frame: Before intervention (up 5 minutes)
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing Aerobic exercise in people with Healthy Subjects, 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 5 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 27 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (0034+649001863, alvaro.reina@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle (time frame: Three measurementes: 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 27 Feb 2025.