An interventional study of Walking apnea at Low Lung Volume and Walking at normal breathing in Pain, Hypoxemia and Hypercapnia, sponsored by Universidad Rey Juan Carlos. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment
The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Universidad Rey Juan Carlos is the lead sponsor of 114 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants walk at 6 km/h (10% slope) on treadmill for 6 minutes performing series of intermitent apneas
Other: Walking apnea at Low Lung Volume
Participants walk with normal breathing at 6 km/h (10% slope) on treadmill for 6 minutes.
Other: Walking at normal breathing
Walking apnea at low Lung Volume Participants walk at 6 km/h (10% slope) on treadmill for 6 minutes. Participants in the experimental group will perform intermittent apneas at high lung volume with a density of 5 seconds, followed by a normal breath of 5 seconds until completing the 6 minutes)
Participants walk at 6 km/h (10% slope) on treadmill for 6 minutes. Participants in the control group will remain breathing normally for these 6 minutes.
Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
PPT is tested on the dorsal base of the distal phalanx of the thumb on the dominant side and on the muscle belly of the tibialis anterior on the dominant side. The region to be pressed is marked with a pen. The patient is instructed to report with 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 thumb, and alternated with tibia and C7 until 3 measurements of each region are obtained, enough time to give 30 seconds of rest between measurements in the same region. This protocol has demonstrated high inter-observer reliability measuring healthy subjects (ICC = 0.91).
Time frame: before and after intervention (up 30 minutes)
Perceived Stress Scale (PSS)
14-item questionnaire about their thoughts and feelings in the last month. The scale has a range of scores from 0 to 56. The lower the score, the more favorable for the patient's health.
Time frame: before intervention (up 5 minutes)
Pittsburg Sleep Quality Index (PSQI)
9-item questionnaire on sleep quality in the past month The scale has a range of scores from 0 to 21. The lower the score, the more favorable for the patient's health.
Time frame: before intervention (up 5 minutes)
Global Physical Activity Questionnaire (GPAQ)
6-item questionnaire on the level of physical activity at work, for commuting and in leisure time.
Time frame: before intervention (up 5 minutes)
Oxygen saturation
Oxygen saturation will be measured during the procedure by finger pulse oximetry.
Time frame: during intervention (up 6 minutes)
Blood pressure
Systolic and diastolic blood pressure will be measured before, during and immediately after the procedure using a digital wrist sphygmomanometer.
Time frame: before and after intervention (up 10 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)
Heart rate
Heart rate will be measured during the procedure by finger pulse oximetry.
Time frame: during intervention (up 6 minutes)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for May 2025, 6 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 6 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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