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Clinical Trials/NCT06158282
NCT06158282RecruitingPhase 3

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

Centro Universitario La Salle1 site in 1 country60 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older 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 4 weeks.

Outcomes

Primary Outcomes

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

  • Pittsburg Sleep Quality Index (PSQI)(before intervention (up 5 minutes))
  • Global Physical Activity Questionnaire (GPAQ)(before intervention (up 5 minutes))
  • Heart rate(during intervention (up 6 minutes))
  • Oxygen saturation(during intervention (up 6 minutes))
  • Rate of perceived exertion (RPE)(immediately after intervention (up 10 seconds))
  • Perceived Stress Scale (PSS)(before intervention (up 5 minutes))
  • Blood pressure(before, during and after intervention (up 10 minutes))

Investigators

Sponsor
Centro Universitario La Salle
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fran de Asís Fernández

Director

Centro Universitario La Salle

Study Sites (1)

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