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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Asymptomatic subjects aged between 18 and 64 years.
Exclusion Criteria
- •Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
- •History of epilepsy.
- •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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- International Physical Activity Questionnaire (IPAQ)(Before intervention (up 5 minutes))
- Heart rate(During intervention (up 30 minutes))
- Rate of perceived exertion (RPE)(Immediately after intervention (up 10 seconds))
- Physical Activity Readiness Questionnaire (PAR-Q)(Before intervention (up 5 minutes))
- Fatigue Assessment Scale (FAS)(Before intervention (up 5 minutes))
Investigators
Álvaro Reina Varona
Principal Investigator
Centro Universitario La Salle