HealthyNCT01953185
MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME IN ELDERLY
A study testing The manual diaphragm release technique in people with Healthy, run by Daniella Cunha Brandao at 1 site in Brazil.
Trial summary
Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding. Read more about this study
- Who is it for?
- Ages 60 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- The manual diaphragm release technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 60 years of age;
- a body mass index (BMI) below 30 kg/m2
- non-smokers, self-declared sedentary;
- presenting a forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted;
- the ratio between these variables (FEV1/FVC) greater than 70% in spirometry
Who cannot join
- Showed the inability to understand verbal commands in the evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME AND UPPER RIB CAGE CONTRIBUTION DURING QUIET BREATHING IN ELDERLY: A RANDOMIZED CONTROLLED TRIAL
Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.
Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control Group (CG) and 08 in the Intervention Group (IG).
Read more
Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten deep breaths, with a one minute interval between them. The CG underwent a sham protocol (light touch), with same sets and time of interval.
Outcome measures: The groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (OEP), in that order, before and immediately after the intervention.
- Conditions
- Healthy
- Being tested
- Sham manual diaphragm release technique, The manual diaphragm release technique
- Keywords
- elderly, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham manual diaphragm release techniqueOther
For this group, light touch at the same anatomical points was done without exerting pressure or traction. Positioning and duration were identical to the IG to perform the sham protocol (Licciardone \& Russo, 2006).
The manual diaphragm release techniqueOther
To perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them.
| Study group | Role | What they receive |
|---|---|---|
| Manual diaphragm release technique | Experimental | Not described Receives: Other: The manual diaphragm release technique |
| Control group | Sham comparator | Not described Receives: Other: Sham manual diaphragm release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compartmental chest wall volume
Measured: 1 day
Secondary outcomes (1)
Pulmonary function
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniella Cunha Brandao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
- Investigators
- Taciano Rocha, Msc, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953185
- Sponsor's protocol ID
- taciano01
- Status last verified
- Dec 2012
- First submitted
- 25 Sep 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
PubMed 14533277De Troyer A. Respiratory effect of the lower rib displacement produced by the diaphragm. J Appl Physiol (1985). 2012 Feb;112(4):529-34. doi: 10.1152/japplphysiol.01067.2011. Epub 2011 Dec 1.
PubMed 22134697
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME AND UPPER RIB CAGE CONTRIBUTION DURING QUIET BREATHING IN ELDERLY: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT01953185
- Acronym / sponsor ID
- taciano01
- Conditions
- Healthy
- Keywords
- elderly, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Daniella Cunha BrandaoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.
Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control Group (CG) and 08 in the Intervention Group (IG).
Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten deep breaths, with a one minute interval between them. The CG underwent a sham protocol (light touch), with same sets and time of interval.
Outcome measures: The groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (OEP), in that order, before and immediately after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual diaphragm release technique | Experimental | Other: The manual diaphragm release technique |
| Control group | Sham comparator | Other: Sham manual diaphragm release technique |
Who may qualify
- Ages
- 60 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 60 years of age;
- a body mass index (BMI) below 30 kg/m2
- non-smokers, self-declared sedentary;
- presenting a forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted;
- the ratio between these variables (FEV1/FVC) greater than 70% in spirometry
Key exclusion criteria (1 listed)
- Showed the inability to understand verbal commands in the evaluation.
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 |
|---|---|---|
| Sham manual diaphragm release techniqueFor this group, light touch at the same anatomical points was done without exerting pressure or traction. Positioning and duration were identical to the IG to perform the sham protocol (Licciardone \& Russo, 2006). | Other | Control group |
| The manual diaphragm release techniqueTo perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them. | Other | Manual diaphragm release technique |
Primary outcome
Compartmental chest wall volume
Time frame: 1 day
1 secondary outcome
Pulmonary function
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Results publication: PubMed 14533277Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
- Results publication: PubMed 22134697De Troyer A. Respiratory effect of the lower rib displacement produced by the diaphragm. J Appl Physiol (1985). 2012 Feb;112(4):529-34. doi: 10.1152/japplphysiol.01067.2011. Epub 2011 Dec 1.
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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.
Taciano Rocha, Msc principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The manual diaphragm release technique in people with Healthy, run by Daniella Cunha Brandao at 1 site in Brazil.
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 5 inclusion and 1 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 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compartmental chest wall volume (time frame: 1 day). 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 NCT01953185, which also lists 2 linked publications.
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 30 Sep 2013.