Effects of Walking Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Apnea; Hypoxia; Hypercapnia
• Intervention / Treatment: Other: Voluntary apnoea

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • CSEU LaSalle
    • Contact: Fran DeAsís-Fernández, PhD; Phone Number: (0034)667000218; Email: frandeasis@lasallecampus.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Walking at normal breathing; Participants walk at 5,5 km/h on treadmill for 6 minutes. Participants in the control group will remain breathing normally for these 6 minutes.
Experimental: Walking apnea at High Lung Volume; Participants walk at 5,5 km/h on treadmill for 6 minutes. Participants in the experimental group will perform intermittent apneas at high lung volume with a density of 15 seconds, followed by a normal breath of 10 seconds (15 cycles of 15s apnea - 10s normal breathing, until completing the 6 minutes)	Other: Voluntary apnoea; Walking apneas at high lung volume with cycles of 15-10s (apnea - breathing) during 6 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	before and after intervention (up 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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. A higher score means higher weekly physical activity	before intervention (up 5 minutes)
Oxygen saturation	Oxygen saturation will be measured during the procedure by finger pulse oximetry.	during intervention (up 6 minutes)
Heart rate	Heart rate will be measured during the procedure by finger pulse oximetry.	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.	before, during 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.	immediately after intervention (up 10 seconds)

Collaborators and Investigators

• Sponsor: Centro Universitario La Salle

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea; Hypoxia; Hypercapnia
• Other Study ID Numbers: CSEULS-PI-017/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No