NCT03732222

Brief Summary

This study investigates the effect of two different techniques, stretching of the diaphragm and cervical level impulse technique C3-C4, in the possible spirometric changes, vital capacity (CV), maximum expiratory flow (PEF) and maximum expiratory volume (FEV). in relation to the secondary variables (age, physical activity, BMI, sex). the subjects of the study were informed and clarified doubts about it and its subsequent reading and signing of informed consent. The subjects were randomly selected to determine which intervention group they would belong to (G1: intervention group of the diaphragm muscle stretch technique, G2: intervention group of the cervical rotation rotation impulse technique C3- C4, G3: Combined technique G1 and G2, G4: control group.The evaluation technique is spirometry.The intervention protocol is as follows, first the pre-intervention spirometry is performed, then the corresponding technique (according to intervention group), then the post-intervention spirometry, the intervention technique and at 5 minutes, the intervention technique is performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1 day

First QC Date

November 3, 2018

Last Update Submit

November 18, 2018

Conditions

Keywords

DiaphragmNeckFrenic Nerve

Outcome Measures

Primary Outcomes (1)

  • forced vital capacity

    volume of air that we can exhale (quickly, sustainably and maximally) after a maximum expiration from the position of maximum inspiration. It is measured in liters (L).

    a week

Secondary Outcomes (1)

  • Forced expiratory volume in the first second

    a week

Other Outcomes (1)

  • Maximum expiratory flow

    a week

Study Arms (3)

Stretching the diaphragm muscle

EXPERIMENTAL

The interventor places his hands on the last costal cartilages and the subject makes an inspiration and keeps his hands resisted in the expiration.

Procedure: Stretching the diaphragm muscle

Impulse technique in rotation of cervical level 3 and 4

EXPERIMENTAL

The thumbs position the head in a double chin and then place it with neutral flexion-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees.

Procedure: Impulse technique in rotation of cervical level 3 and 4

Combined technique of diaphragm muscle stretch and cervical ro

EXPERIMENTAL

combine both previous techniques.

Procedure: Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4

Interventions

Place the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration.

Stretching the diaphragm muscle

head to double chin position and then placed with neutral flexo-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees.

Impulse technique in rotation of cervical level 3 and 4

The same initial position, hand placement and technique guidelines will be used, cited in each of the techniques performed in the "intervention 1" group and the "intervention 2" group.

Combined technique of diaphragm muscle stretch and cervical ro

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Accept participating in the study (signature of informed consent).
  • Be in an age range between 18 and 50 years.

You may not qualify if:

  • Have obstructive and / or restrictive respiratory problems.
  • Perfect transient conditions that affect the respiratory tract, such as colds, sinusitis, influenza, respiratory allergies.
  • To have a history of rib fractures.
  • Congenital deformities.
  • To have digestive problems.
  • Paying hepatitis and / or hepatobiliary lesions.
  • Suffer heart disease and / or arterial hypertension.
  • Have abdominal problems.
  • Provide surgical scar on the abdomen, thorax and / or neck.
  • Patience cancer
  • Press any type of pain at the time of conducting the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, Moncada, 46113, Spain

Location

Related Publications (1)

  • Kendall FP, Mac Creary EK, Provance PG. Muscles: functional tests, posture and pain. 5th ed. Madrid: Marbán; 2007 Souchard PE. RPG Principles of global postural reeducation. 1st ed. Barcelona: Paidotribo; 2005 American Thoracic Society / European Respiratory Society. ATS / ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002; 166: 518-624.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Rocha Ortiz

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the masking of the evaluator has been obtained, measuring the association between the response variables at baseline and the intervention group, by means of the variance analysis (ANOVA), for each response variable separately. We have verified that there are no differences between the means of the responses at the baseline level in each assigned intervention group, so that masking at the level of the evaluator has been carried out correctly
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2018

First Posted

November 6, 2018

Study Start

November 5, 2018

Primary Completion

November 6, 2018

Study Completion

November 18, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations