Healthy IndividualsNCT03065283
Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women
A study testing Diaphragm lift and Relaxation of the diaphragm pillars in people with Healthy Individuals, run by Universidade Federal do Ceara.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Diaphragm lift and Relaxation of the diaphragm pillars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sedentary female participants
- aged between 18 and 35 years.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Individuals
- Being tested
- Diaphragm lift, Relaxation of the diaphragm pillars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm liftProcedure or surgery
Also called Diaphragmatic release 1
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
Relaxation of the diaphragm pillarsProcedure or surgery
Also called Diaphragmatic release 2
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
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic release | Active comparator | The stretching of the peripheral fibers of the diaphragm Receives: Procedure: Diaphragm lift; Procedure: 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 Receives: Procedure: Diaphragm lift; Procedure: Relaxation of the diaphragm pillars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic Mobility
Thoracic mobility was measued with a tape as an evaluation tool.
Measured: baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Olavo de Paula Lima, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065283
- Sponsor's protocol ID
- POdePLima2
- Status last verified
- Apr 2020
- First submitted
- 6 Feb 2017
- Last updated
- 16 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30368336
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03065283
- Acronym / sponsor ID
- POdePLima2
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic release | Active comparator | Procedure: Diaphragm lift, Procedure: Relaxation of the diaphragm pillarsThe stretching of the peripheral fibers of the diaphragm |
| Diaphragmatic release control | Placebo comparator | Procedure: Diaphragm lift, Procedure: Relaxation of the diaphragm pillarsIn both placebo techniques, only the light touching of the contacts of the volunteers' skin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- sedentary female participants
- aged between 18 and 35 years.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm liftAlso: Diaphragmatic release 1The 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 | Procedure or surgery | Diaphragmatic release, Diaphragmatic release control |
| Relaxation of the diaphragm pillarsAlso: Diaphragmatic release 2Second 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 | Procedure or surgery | Diaphragmatic release, Diaphragmatic release control |
Primary outcome
Thoracic Mobility
Time frame: baseline and immediately post-intervention
Thoracic mobility was measued with a tape as an evaluation tool.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30368336Marizeiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm lift and Relaxation of the diaphragm pillars in people with Healthy Individuals, run by Universidade Federal do Ceara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic Mobility (time frame: baseline and immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.