- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03732222
Stretching of the Diaphragm and Cervical Impulse Technique and Its Possible Spirometric Changes
November 18, 2018 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Moncada
-
Valencia, Moncada, Spain, 46113
- Universidad CEU Cardenal Herrera
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stretching the diaphragm muscle
The interventor places his hands on the last costal cartilages and the subject makes an inspiration and keeps his hands resisted in the expiration.
|
Place the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration.
|
|
Experimental: Impulse technique in rotation of cervical level 3 and 4
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.
|
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.
|
|
Experimental: Combined technique of diaphragm muscle stretch and cervical ro
combine both previous techniques.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
forced vital capacity
Time Frame: a week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced expiratory volume in the first second
Time Frame: a week
|
Maximum expiratory volume in the first second.
Volume obtained in the first second of the forced vital capacity maneuver.
|
a week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum expiratory flow
Time Frame: a week
|
peak or peak expiratory flow obtained during the forced expiratory maneuver
|
a week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rocha Ortiz, Cardenal Herrera University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2018
Primary Completion (Actual)
November 6, 2018
Study Completion (Actual)
November 18, 2018
Study Registration Dates
First Submitted
November 3, 2018
First Submitted That Met QC Criteria
November 3, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 18, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCH CEU 208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Disease
-
Altesa Biosciences, Inc.CompletedHealthy | Pulmonary Disease | COPD | Respiratory Disease | Lower Respiratory DiseaseUnited States
-
Altesa Biosciences, Inc.Virtus Respiratory ResearchCompletedRCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory InfectionInfections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract Diseases | Lung Diseases | Pulmonary Disease, Chronic Obstructive | Enterovirus Infections | Copd | Pulmonary Disease | Respiratory Disease | Respiratory Complication | Upper Respiratory Tract Infections | Respiratory Viral Infection | ... and other conditionsUnited Kingdom
-
FisioRespiraciónUniversidad Complutense de Madrid; NeumomadridUnknownAcute Disease RespiratorySpain
-
Società Italiana di Allergologia, Asma e Immunologia...Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)Recruiting
-
Rochester General HospitalCompletedAspirin-exacerbated Respiratory DiseaseUnited States
-
SOS Oxygene MediterraneeRecruitingExercise | Chronic Respiratory DiseaseFrance
-
West Park Healthcare CentreEnrolling by invitation
-
KorianCompletedChronic Respiratory DiseaseFrance
-
Rambam Health Care CampusUnknown
-
Larissa University HospitalRecruitingRespiratory Disease (Clinically Stable Individuals - Patients Recovered From Respiratory Disease)Greece
Clinical Trials on Stretching the diaphragm muscle
-
University of PatrasRecruitingDiastasis Recti Abdominis (DRA)Greece
-
University Medical Center NijmegenUnknownSepsis | Mechanical VentilationNetherlands
-
Escola Superior de Tecnologia da Saúde do PortoNot yet recruitingNonspecific Low Back PainPortugal
-
Jagiellonian UniversityRecruitingLow Back Pain | Diaphragm; RelaxationPoland
-
Helga Cecília Muniz de SouzaUniversidade Federal de PernambucoCompleted
-
Universidad de GranadaCompleted
-
Universitat Internacional de CatalunyaRecruiting
-
University Hospital, GenevaCompleted
-
University of CalgaryCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Alberta Heritage... and other collaboratorsCompleted