HealthyNCT01975740
Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly
A study testing The manual diaphragm release technique in people with Healthy, run by Universidade Federal de Pernambuco 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
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Feb 2013
- 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 Effects On 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham manual diaphragm release techniqueOther
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 |
| Sham manual diaphragm release technique | Other | 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 distribution
The analysis of the regional distribution of respiratory volumes was done with Optoelectronic plethysmography (BTS Bioengineering, Italy), in which 89 reflective markers were adhered to the skin of volunteers using hypoallergenic adhesives, on particular anatomical points of the chest wall and abdomen (Aliverti and Pedotti 2003). The device emitted an infrared light on the reflective markers which was captured by eight cameras around the room, allowing the spatial determination of each marker. Thus, changes in lung volumes were calculated at each of the three compartments of the rib cage: pulmonary or upper ribcage (Rc, p), abdominal or lower ribcage (Rc, a) and abdomen (Ab). After the first OEP evaluation, a nontoxic, hypoallergenic pen was used to mark the placement of the dorsal reflective markers allowing the patient to lay in supine for the manual technique or the sham. The markers were then placed at the exact same anatomical points for reevaluation.
Measured: before first session
Secondary outcomes (2)
Maximal inspiratory and expiratory pressures
The maximal inspiratory and expiratory pressures (MIP, MEP) were obtained from the residual volume and total lung capacity, respectively, according to the criteria of the ATS/ERS (ATS/ERS, 2002) and measured using a portable digital manometer, model MVD 300 (® MDI Ltd., Brazil).
Measured: Before first session
Pulmonary Function
To assess the participant's lung function, a portable Micro Loop 8 (Micromedical, England) spirometer was used to evaluate the forced maneuver (Miller et al 2005). The study followed the criteria of acceptability in accordance with the ATS/ERS (2005). Values of FEV1, forced vital capacity (FVC), peak expiratory flow (PEF) and FEV1/FVC were obtained.
Measured: Before first session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975740
- Sponsor's protocol ID
- Diaphragm Manual Technique
- Status last verified
- Oct 2013
- First submitted
- 29 Oct 2013
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Diaphragm Release Technique Effects On Tidal Volume And Upper Rib Cage Contribution During Quiet Breathing In Elderly: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01975740
- Acronym / sponsor ID
- Diaphragm Manual Technique
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Nov 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
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual diaphragm release technique | Experimental | Other: The manual diaphragm release technique |
| Sham manual diaphragm release technique | Other | 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 technique | Other | Sham manual diaphragm release technique |
| 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 distribution
Time frame: before first session
The analysis of the regional distribution of respiratory volumes was done with Optoelectronic plethysmography (BTS Bioengineering, Italy), in which 89 reflective markers were adhered to the skin of volunteers using hypoallergenic adhesives, on particular anatomical points of the chest wall and abdomen (Aliverti and Pedotti 2003). The device emitted an infrared light on the reflective markers which was captured by eight cameras around the room, allowing the spatial determination of each marker. Thus, changes in lung volumes were calculated at each of the three compartments of the rib cage: pulmonary or upper ribcage (Rc, p), abdominal or lower ribcage (Rc, a) and abdomen (Ab). After the first OEP evaluation, a nontoxic, hypoallergenic pen was used to mark the placement of the dorsal reflective markers allowing the patient to lay in supine for the manual technique or the sham. The markers were then placed at the exact same anatomical points for reevaluation.
2 secondary outcomes
Maximal inspiratory and expiratory pressures
Time frame: Before first session
Pulmonary Function
Time frame: Before first session
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 5 Nov 2013.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
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 Universidade Federal de Pernambuco 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 5 Nov 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. 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 distribution (time frame: before first session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2013.