A Phase 1 interventional study of Aerobic exercise and Aerobic exercise in Healthy Subjects, sponsored by Centro Universitario La Salle. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Centro Universitario La Salle · Phase 1, Interventional, and Treatment
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.
Centro Universitario La Salle is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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.
Other: Aerobic exercise
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.
Other: Aerobic exercise
Participants in the control group will remain seated for the entire 30-minute duration of the experiment without receiving any form of distraction.
Aerobic exercise with lower limb cycle ergometer
Aerobic exercise with upper limb cycle ergometer
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).
Time frame: Three measurementes: before, immediately after intervention, and 30 minutes after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before intervention (up 5 minutes)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Jul 2025, 15 months after the start.
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Centro Universitario La Salle