Effects of Walking Apnea At High Lung Volume on Hypoalgesia

Not Applicable

Recruiting

• Conditions: Pain; Hypoxemia; Hypercapnia; Apnea

• Registration Number: NCT06638528
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Start: 2024-11-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria

• 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 4 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7	before and after intervention (up 30 minutes)	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).

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS)	before intervention (up 5 minutes)	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.
Pittsburg Sleep Quality Index (PSQI)	before intervention (up 5 minutes)	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.
Global Physical Activity Questionnaire (GPAQ)	before intervention (up 5 minutes)	6-item questionnaire on the level of physical activity at work, for commuting and in leisure time. A higher score means higher weekly physical activity
Heart rate	during intervention (up 6 minutes)	Heart rate will be measured during the procedure by finger pulse oximetry.
Oxygen saturation	during intervention (up 6 minutes)	Oxygen saturation will be measured during the procedure by finger pulse oximetry.
Rate of perceived exertion (RPE)	immediately after intervention (up 10 seconds)]	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.

Trial Locations

Locations (1)

CSEU LaSalle; 🇪🇸 Madrid, Spain