Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women

April 7, 2020 updated by: Pedro Olavo de Paula Lima, Universidade Federal do Ceara

Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women: a Randomized Clinical Trial

The aim of this study was to evaluate the immediate effects of diaphragmatic release techniques on posterior chain flexibility and lumbar spine amplitude. Respiratory muscle strength and chest cavity mobility in healthy women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study was to evaluate the immediate effects of diaphragmatic release techniques on posterior chain flexibility and lumbar spine amplitude; Respiratory muscle strength and chest cavity mobility in healthy women. This is an intervention study with a randomized controlled trial design. The randomized study in two groups, the Intervention Group in which two diaphragmatic release techniques were performed and the Control Group where two placebo techniques were applied in 75 participants between 18 and 35 years of age. For intragroup analysis the paired Student t test was used, comparing the outcomes before and after the intervention and for intergroup analysis the independent Student t test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • sedentary female participants
  • aged between 18 and 35 years.

Exclusion Criteria:

  • those with cardiovascular, respiratory obstructive or restrictive disease
  • smokers and ex-smokers
  • who were or were submitted to speech therapy less than a year ago
  • those with postural deviation type scoliosis

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Diaphragmatic release
The stretching of the peripheral fibers of the diaphragm
Procedure: Diaphragm lift
The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice
Other Names:
  • Diaphragmatic release 1
Procedure: Relaxation of the diaphragm pillars
Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute
Other Names:
  • Diaphragmatic release 2
Placebo Comparator: Diaphragmatic release control
In both placebo techniques, only the light touching of the contacts of the volunteers' skin
Procedure: Diaphragm lift
The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice
Other Names:
  • Diaphragmatic release 1
Procedure: Relaxation of the diaphragm pillars
Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute
Other Names:
  • Diaphragmatic release 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thoracic Mobility
Time Frame: baseline and immediately post-intervention
Thoracic mobility was measued with a tape as an evaluation tool.
baseline and immediately post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Amplitude of Motion of the Lumbar Spine
Time Frame: baseline and immediately post-intervention
Tape measure was used as an evaluation tool.
baseline and immediately post-intervention
Posterior Chain Flexibility
Time Frame: baseline and immediately post-intervention
Tape measure was used as an evaluation tool.
baseline and immediately post-intervention
Maximum Respiratory Pressure
Time Frame: baseline and immediately post-intervention
manovacuometer was used as an evaluation tool.
baseline and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Ceara

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POdePLima2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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