Condition category
Respiratory
Date applied
18/03/2016
Date assigned
09/10/2016
Last edited
06/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Breathing causes the trunk (torso) and ribcage to move. In some cases, this movement can cause unsteadiness and changes in posture and gait (pattern of movement of the limbs while moving). In order to better understand the way that posture changes during breathing, this study will look at the mechanics of breathing and what effect this has on the way a person moves. The aim of this study is to find out whether posture is influenced by breathing and the mechanism by which this happens.

Who can participate?
Healthy French adults.

What does the study involve?
All participants attend a single study visit which takes around four hours. At the visit, the participant’s posture is measured by taking a series of pictures taken using low dose x-rays while they are breathing calmly, after taking a deep breath and after breathing out fully in both sitting and standing positions. The participants then have 78 reflective markers attached to their whole body so that their motion can be monitored to assess their posture, and complete five different breathing patterns for one minute each in a standing position and then a sitting position. This involves quiet breathing with open eyes and mouth, closed eyes and open mouth, open eyes and closed mouth, closed eyes and mouth, and finally quiet breathing for 30 seconds with eyes open, followed by holding the breath for 10-15 sections and then deep breathing for 30 sections. Participants also take part in a walking test to measure their gait speed and have their lung volume measured by blowing into a machine called a spirometer.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
1. Laboratoire de biomécanique humaine Georges charpak Arts et Métiers ParisTech (France)
2. Hôpital Pitié-Salpêtrière (France)

When is the study starting and how long is it expected to run for?
November 2014 to October 2019

Who is funding the study?
National School of Arts and Trades (France)

Who is the main contact?
Dr Valeria Attali
valerie.attali@aphp.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Valerie Attali

ORCID ID

http://orcid.org/0000-0001-5444-9223

Contact details

Pitié-Salpêtrière Hospital
47-83 Boulevard de l'Hôpital
paris
75013
France
+33 1 44964032
valerie.attali@aphp.fr

Additional identifiers

EudraCT number

2016-001243-39

ClinicalTrials.gov number

Protocol/serial number

06036

Study information

Scientific title

Postural adaptations linked to respiration in healthy and in respiratory diseases

Acronym

Study hypothesis

Posture is influenced by respiration.

Ethics approval

Comité de Protection des Personnes Ile-de-France VI, 18/02/2015, ref: RCB 2006-A00386-45

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Respiratory diseases

Intervention

All participants attend a single study visit, which lasts for approximately four hours. Once a participant is deemed eligible and provides informed consent, participants undergo a range of medical examinations. There is no follow up planned after the study visit.

Angulations of posture are measured using the EOS® system. Six pairs of images will be done, three in sitting position (during calm breathing, after a full inspiration and after a full expiration) , three in standing position in the same conditions. This process takes approximately 30 minutes

Modification of centre of pressure is measured using a force platform on the floor. This involves the application of 78 reflective markers to the whole body, including 35 on the thorax and the abdomen. Motion capture is undertaken using an optoelectronic VICON system. Participants are instructed to perform five different breathing patterns for one minute each in standing position followed by sitting position. This process takes two hours. The breathing patterns are:
1. Quiet breathing with open eyes and mouth
2. Quiet breathing with closed eyes and open mouth
3. Quiet breathing with eyes open and closed mouth
4. Quiet breathing with eyes and mouth closed
5. Quiet breathing for 30 seconds with eyes open, followed by a very short apnea (10-20 seconds) and then deep breathing for 30 seconds

Gait velocity is measured using the stand up and go test. Subject is sitting on a chair and is instructed to stand up, to walk 3 metres, to return and to sit again. Velocity is measured. It takes less than 10 minutes

Lung volume is measured using spirometry. This involves the participants being instructed to blow through a mouth piece as hard as possible (quiet breathing followed by one deep inspiration and one deep expiration).

Intervention type

Other

Phase

Drug names

Primary outcome measures

Postural stability is assessed using a force platform and motion capture taken by an optoelectronic VICON system at the study visit

Secondary outcome measures

1. Angulations in posture is measured using the EOS® system at the study visit
2. Gait velocity is measured using the stand up and go test at the study visit
3. Lung volume is measured using spirometry at the study visit

Overall trial start date

21/11/2014

Overall trial end date

30/10/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy participants
2. Aged 18 years and over
3. French nationality

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Pregnancy (female patients)
2. Known chronic respiratory disease such as asthma, COPD etc.
3. Known chronic postural disease such as scoliosis, etc.
5. Acute infection of respiratory tract
5. Aged under 18 years

Recruitment start date

02/11/2016

Recruitment end date

31/10/2018

Locations

Countries of recruitment

France

Trial participating centre

Laboratoire de biomécanique humaine Georges charpak Arts et Métiers ParisTech
155 boulevard de l'hôpital
Paris
75013
France

Trial participating centre

Hôpital Pitié-Salpêtrière
47-83 boulevard de l'hôpital
PAris
75013
France

Sponsor information

Organisation

National Scientific Research Centre (Centre National de la Recherche Scientifique)

Sponsor details

3 Rue Michel Ange
paris
75794
France
+33 1 44964032
valerie.attali@aphp.fr

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

National School of Arts and Trades (Ecole Nationale Supérieure d'Arts et Métiers)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
participant level data will be available upon request to Dr Valérie Attali (valerie.attali@aphp.fr)

Intention to publish date

30/04/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes