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Stretching of the Diaphragm and Cervical Impulse Technique and Its Possible Spirometric Changes

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stretching the diaphragm muscle
Impulse technique in rotation of cervical level 3 and 4
Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Disease focused on measuring Diaphragm, Neck, Frenic Nerve

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Accept participating in the study (signature of informed consent).
  • Be in an age range between 18 and 50 years.
  • Do not present any exclusion criteria.

Exclusion Criteria:

  • Do not meet the inclusion criteria.
  • 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.

Sites / Locations

  • Universidad CEU Cardenal Herrera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stretching the diaphragm muscle

Impulse technique in rotation of cervical level 3 and 4

Combined technique of diaphragm muscle stretch and cervical ro

Arm Description

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

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.

combine both previous techniques.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Forced expiratory volume in the first second
Maximum expiratory volume in the first second. Volume obtained in the first second of the forced vital capacity maneuver.

Full Information

First Posted
November 3, 2018
Last Updated
November 18, 2018
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT03732222
Brief Title
Stretching of the Diaphragm and Cervical Impulse Technique and Its Possible Spirometric Changes
Official Title
Analysis, Evaluation and Comparison of Spirometric Values After the Application of the Diaphragm Muscle Stretch Technique and the Cervical Level Rotation Impulse Technique of C3-C4
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The objectives of the study are the following: 1. To evaluate the changes in the values of the simple spirometry after the application of the study techniques: muscle stretching technique of the diaphragm (G1), rotation impulse technique of the cervical level of C3- C4 (G2) and combined technique of both (G3); 2. Determine the influence of these on measurable respiratory parameters by simple spirometry; 3. Compare the spirometric values obtained after applying the study techniques (G1, G2, G3) and the control group (G4: simulation of a previous technique); and 4. Analyze the different variables measured (age, gender, weight, height, sports practice and body mass index) in the effects of the applied treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
Keywords
Diaphragm, Neck, Frenic Nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching the diaphragm muscle
Arm Type
Experimental
Arm Description
The interventor places his hands on the last costal cartilages and the subject makes an inspiration and keeps his hands resisted in the expiration.
Arm Title
Impulse technique in rotation of cervical level 3 and 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined technique of diaphragm muscle stretch and cervical ro
Arm Type
Experimental
Arm Description
combine both previous techniques.
Intervention Type
Procedure
Intervention Name(s)
Stretching the diaphragm muscle
Intervention Description
Place the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration.
Intervention Type
Procedure
Intervention Name(s)
Impulse technique in rotation of cervical level 3 and 4
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4
Intervention Description
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.
Primary Outcome Measure Information:
Title
forced vital capacity
Description
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).
Time Frame
a week
Secondary Outcome Measure Information:
Title
Forced expiratory volume in the first second
Description
Maximum expiratory volume in the first second. Volume obtained in the first second of the forced vital capacity maneuver.
Time Frame
a week
Other Pre-specified Outcome Measures:
Title
Maximum expiratory flow
Description
peak or peak expiratory flow obtained during the forced expiratory maneuver
Time Frame
a week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Accept participating in the study (signature of informed consent). Be in an age range between 18 and 50 years. Do not present any exclusion criteria. Exclusion Criteria: Do not meet the inclusion criteria. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocha Ortiz
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Valencia
State/Province
Moncada
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
background
Links:
URL
http://www.uchceu.es
Description
The University CEU-Cardenal Herrera is the first private university in the Valencian Community. It belongs to the Foundation San Pablo- CEU and is the leading educational organization in Spain with three Universities all over Spain

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Stretching of the Diaphragm and Cervical Impulse Technique and Its Possible Spirometric Changes

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