ISRCTN ISRCTN56129394
DOI https://doi.org/10.1186/ISRCTN56129394
EudraCT/CTIS number 2016-001243-39
Secondary identifying numbers 06036
Submission date
18/03/2016
Registration date
09/10/2016
Last edited
12/02/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Valerie Attali
Scientific

Pitié-Salpêtrière Hospital
47-83 Boulevard de l'Hôpital
paris
75013
France

ORCiD logoORCID ID 0000-0001-5444-9223
Phone +33 1 44964032
Email valerie.attali@aphp.fr

Study information

Study designNon-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titlePostural adaptations linked to respiration in healthy and in respiratory diseases
Study objectivesPosture is influenced by respiration.
Ethics approval(s)Comité de Protection des Personnes Ile-de-France VI, 18/02/2015, ref: RCB 2006-A00386-45
Health condition(s) or problem(s) studiedRespiratory diseases
InterventionAll 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 typeOther
Primary outcome measurePostural stability is assessed using a force platform and motion capture taken by an optoelectronic VICON system at the study visit
Secondary outcome measures1. 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 study start date21/11/2014
Completion date30/10/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants180
Key inclusion criteria1. Healthy participants
2. Aged 18 years and over
3. French nationality
Key exclusion criteria1. 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
Date of first enrolment02/11/2016
Date of final enrolment31/10/2018

Locations

Countries of recruitment

  • France

Study participating centres

Laboratoire de biomécanique humaine Georges charpak Arts et Métiers ParisTech
155 boulevard de l'hôpital
Paris
75013
France
Hôpital Pitié-Salpêtrière
47-83 boulevard de l'hôpital
PAris
75013
France

Sponsor information

National Scientific Research Centre (Centre National de la Recherche Scientifique)
University/education

3 Rue Michel Ange
paris
75794
France

Phone +33 1 44964032
Email valerie.attali@aphp.fr
ROR logo "ROR" https://ror.org/02feahw73

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date30/04/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planparticipant level data will be available upon request to Dr Valérie Attali (valerie.attali@aphp.fr)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results posturo-respiratory coupling in a group of OSAS patients (ISRCTN70932171) and matched controls (this study) 07/02/2020 16/05/2023 Yes No
Results article 29/04/2019 12/02/2025 Yes No

Editorial Notes

12/02/2025: Publication reference added.
16/05/2023: Publication reference added.