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

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ClinicalTrials.gov Identifier: NCT03065283
Recruitment Status : Completed
First Posted : February 27, 2017
Results First Posted : April 7, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Pedro Olavo de Paula Lima, Universidade Federal do Ceara

Tracking Information
First Submitted Date  ICMJE February 6, 2017
First Posted Date  ICMJE February 27, 2017
Results First Submitted Date  ICMJE September 24, 2019
Results First Posted Date  ICMJE April 7, 2020
Last Update Posted Date April 16, 2020
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
Thoracic Mobility [ Time Frame: baseline and immediately post-intervention ]
Thoracic mobility was measued with a tape as an evaluation tool.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
Thoracic Mobility [ Time Frame: up to six months ]
Tape measure
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2020)
  • Amplitude of Motion of the Lumbar Spine [ Time Frame: baseline and immediately post-intervention ]
    Tape measure was used as an evaluation tool.
  • Posterior Chain Flexibility [ Time Frame: baseline and immediately post-intervention ]
    Tape measure was used as an evaluation tool.
  • Maximum Respiratory Pressure [ Time Frame: baseline and immediately post-intervention ]
    manovacuometer was used as an evaluation tool.
Original Other Pre-specified Outcome Measures
 (submitted: February 21, 2017)
  • Amplitude of Motion of the Lumbar Spine [ Time Frame: up to six months ]
    Tape measure
  • Posterior Chain Flexibility [ Time Frame: up to six months ]
    Tape measure
  • Maximum Respiratory Pressure [ Time Frame: up to six months ]
    manovacuometer
 
Descriptive Information
Brief Title  ICMJE Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women
Official Title  ICMJE Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women: a Randomized Clinical Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Healthy Individuals
Intervention  ICMJE
  • 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 Name: 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 Name: Diaphragmatic release 2
Study Arms  ICMJE
  • Active Comparator: Diaphragmatic release
    The stretching of the peripheral fibers of the diaphragm
    Interventions:
    • Procedure: Diaphragm lift
    • Procedure: Relaxation of the diaphragm pillars
  • Placebo Comparator: Diaphragmatic release control
    In both placebo techniques, only the light touching of the contacts of the volunteers' skin
    Interventions:
    • Procedure: Diaphragm lift
    • Procedure: Relaxation of the diaphragm pillars
Publications * Marizeiro DF, Florêncio 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2020)
75
Original Actual Enrollment  ICMJE
 (submitted: February 21, 2017)
4
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03065283
Other Study ID Numbers  ICMJE POdePLima2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pedro Olavo de Paula Lima, Universidade Federal do Ceara
Study Sponsor  ICMJE Universidade Federal do Ceara
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal do Ceara
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP