NCT03065283

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 7, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

February 6, 2017

Results QC Date

September 24, 2019

Last Update Submit

April 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thoracic Mobility

    Thoracic mobility was measued with a tape as an evaluation tool.

    baseline and immediately post-intervention

Other Outcomes (3)

  • Amplitude of Motion of the Lumbar Spine

    baseline and immediately post-intervention

  • Posterior Chain Flexibility

    baseline and immediately post-intervention

  • Maximum Respiratory Pressure

    baseline and immediately post-intervention

Study Arms (2)

Diaphragmatic release

ACTIVE COMPARATOR

The stretching of the peripheral fibers of the diaphragm

Procedure: Diaphragm liftProcedure: Relaxation of the diaphragm pillars

Diaphragmatic release control

PLACEBO COMPARATOR

In both placebo techniques, only the light touching of the contacts of the volunteers' skin

Procedure: Diaphragm liftProcedure: Relaxation of the diaphragm pillars

Interventions

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

Also known as: Diaphragmatic release 1
Diaphragmatic releaseDiaphragmatic release control

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

Also known as: Diaphragmatic release 2
Diaphragmatic releaseDiaphragmatic release control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.

Results Point of Contact

Title
Prof. Dr. Pedro Lima
Organization
Department of Physical Therapy

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The sample was randomly divided by electronic draw in two groups, the intervention group (GI), where two techniques were performed, one for diaphragmatic release and another for relaxation of the diaphragm pillars. In the control group (CG) the same techniques were applied, but in a placebo form.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University professor of physiotherapy course Federal University of CearĂ¡

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 27, 2017

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 16, 2020

Results First Posted

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share