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NCT Number: NCT06638515

Effects of Walking Apnea At Low Lung Volume on Hypoalgesia

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.

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Key information

Conditions

Pain Apnea Apneas Hypercapnia Hypoxemia Hypoxia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walking apnea at Low Lung Volume

Other

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)

Walking at normal breathing

Other

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.

Primary outcomes

  1. Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7

    Time frame: 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 outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: 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.

  2. Pittsburg Sleep Quality Index (PSQI)

    Time frame: 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.

  3. Global Physical Activity Questionnaire (GPAQ)

    Time frame: before intervention (up 5 minutes)

    6-item questionnaire on the level of physical activity at work, for commuting and in leisure time.

  4. Oxygen saturation

    Time frame: during intervention (up 6 minutes)

    Oxygen saturation will be measured during the procedure by finger pulse oximetry.

  5. Blood pressure

    Time frame: before and after intervention (up 10 minutes)

    Systolic and diastolic blood pressure will be measured before, during and immediately after the procedure using a digital wrist sphygmomanometer.

  6. Rate of perceived exertion (RPE)

    Time frame: 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.

  7. Heart rate

    Time frame: during intervention (up 6 minutes)

    Heart rate will be measured during the procedure by finger pulse oximetry.

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco de Asís Fernandez

CONTACT

[email protected]

(0034)667000218

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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