Physical ActivitySHERPAMNCT03673189
Sensors for HEalth Recording and Physical Activity Monitoring
A study testing sensors in people with Physical Activity, run by Rennes University Hospital at 1 site in France.
Trial summary
The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2018to 12 Sep 2019
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers Healthy active subjects aged 50 or over (ie without diagnosed disease, without chronic treatment) and recruited in the sports associations of Ille et Vilaine (cycle tourism clubs).
- having benefited from an oral or written prescription of physical activity carried out by a health professional and applying this prescription daily in autonomy or in a sports club.
- Common to all subjects
- physically active (adherent to a club or sports association or practicing independently according to the recommendations of their physician);
- practicing at least once a week;
- residence located less than 100 km return from Rennes University Hospital
- affiliate or beneficiary of a social protection scheme;
- having given his written consent
Who cannot join
- Common to all subjects
- wearing a pacemaker or implanted cardiac defibrillator (precaution because using telemetry);
- participation in another research protocol;
- persons aver 18 yrs-old subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
- pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Biologie et médecine du Sport
Rennes, Brittany Region, 35000
About this study
The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.
Read the detailed description
To assess the SHERPAM Device (DS) by the continuous acquisition and transmission of data (accelerations, rotations, alterations in thoracic volume, heart rate, electrocardiogram) in a real life physical activity practice (subjects in their living environment and during their usual physical practices) using the DS's real-time communication tools, automatic data processing, and the DS's ability to produce information.
- Conditions
- Physical Activity
- Being tested
- sensors
- Keywords
- Sensors, Health Recording
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorsDevice
Acquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Sensors assigned for 3 weeks Receives: Device: sensors |
| Patients with arythmic disease or peripheral vascular disease | Experimental | Sensors assigned for 3 weeks Receives: Device: sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
asses the continuous acquisition of data by sensors
transmission and reception of physiological parameters of a patient
Measured: every day (during 3 weeks)
Secondary outcomes (4)
Test acceptability of SHERPAM Device
questionnary
Measured: after 7 days of use
Test acceptability of Sherpam Device
questionnary
Measured: after 21 days of use
Test usability of Sherpam Device
questionnary
Measured: after 7 days of use
Test usability of Sherpam Device
questionnary
Measured: after 21 days of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start28 Jun 2018
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric, with healthy volunteers and patients
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LTSI-INSERM U1099, CIC-IT 14-14
- Responsible party
- Sponsor
- Investigators
- Carre François, MD, Principal investigator, University of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673189
- Sponsor's protocol ID
- 35RC17_8836
- Acronym
- SHERPAM
- Status last verified
- May 2023
- First submitted
- 12 Jun 2018
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houssein A, Ge D, Gastinger S, Dumond R, Prioux J. Estimation of respiratory variables from thoracoabdominal breathing distance: a review of different techniques and calibration methods. Physiol Meas. 2019 Apr 3;40(3):03TR01. doi: 10.1088/1361-6579/ab0b63.
PubMed 30818285Dumond R, Gastinger S, Rahman HA, Le Faucheur A, Quinton P, Kang H, Prioux J. Estimation of respiratory volume from thoracoabdominal breathing distances: comparison of two models of machine learning. Eur J Appl Physiol. 2017 Aug;117(8):1533-1555. doi: 10.1007/s00421-017-3630-0. Epub 2017 Jun 13.
PubMed 28612121Khreis S, Ge D, Rahman HA, Carrault G. Breathing Rate Estimation Using Kalman Smoother With Electrocardiogram and Photoplethysmogram. IEEE Trans Biomed Eng. 2020 Mar;67(3):893-904. doi: 10.1109/TBME.2019.2923448. Epub 2019 Jun 17.
PubMed 31217092
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensors for HEalth Recording and Physical Activity Monitoring
- ClinicalTrials.gov ID
- NCT03673189
- Acronym / sponsor ID
- SHERPAM / 35RC17_8836
- Conditions
- Physical Activity
- Keywords
- Sensors, Health Recording
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- LTSI-INSERM U1099, CIC-IT 14-14
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- 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.
The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.
Detailed description
To assess the SHERPAM Device (DS) by the continuous acquisition and transmission of data (accelerations, rotations, alterations in thoracic volume, heart rate, electrocardiogram) in a real life physical activity practice (subjects in their living environment and during their usual physical practices) using the DS's real-time communication tools, automatic data processing, and the DS's ability to produce information.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, monocentric, with healthy volunteers and patients
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: sensorsSensors assigned for 3 weeks |
| Patients with arythmic disease or peripheral vascular disease | Experimental | Device: sensorsSensors assigned for 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers Healthy active subjects aged 50 or over (ie without diagnosed disease, without chronic treatment) and recruited in the sports associations of Ille et Vilaine (cycle tourism clubs).
- Common to all subjects
- physically active (adherent to a club or sports association or practicing independently according to the recommendations of their physician);
- practicing at least once a week;
- residence located less than 100 km return from Rennes University Hospital
Key exclusion criteria (5 listed)
- Common to all subjects
- wearing a pacemaker or implanted cardiac defibrillator (precaution because using telemetry);
- participation in another research protocol;
- persons aver 18 yrs-old subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
- pregnant or nursing woman.
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 |
|---|---|---|
| sensorsAcquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio. | Device | Healthy volunteers, Patients with arythmic disease or peripheral vascular disease |
Primary outcome
asses the continuous acquisition of data by sensors
Time frame: every day (during 3 weeks)
transmission and reception of physiological parameters of a patient
4 secondary outcomes
Test acceptability of SHERPAM Device
Time frame: after 7 days of use
Test acceptability of Sherpam Device
Time frame: after 21 days of use
Test usability of Sherpam Device
Time frame: after 7 days of use
Test usability of Sherpam Device
Time frame: after 21 days of use
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 24 May 2023.
- Results publication: PubMed 30818285Houssein A, Ge D, Gastinger S, Dumond R, Prioux J. Estimation of respiratory variables from thoracoabdominal breathing distance: a review of different techniques and calibration methods. Physiol Meas. 2019 Apr 3;40(3):03TR01. doi: 10.1088/1361-6579/ab0b63.
- Results publication: PubMed 28612121Dumond R, Gastinger S, Rahman HA, Le Faucheur A, Quinton P, Kang H, Prioux J. Estimation of respiratory volume from thoracoabdominal breathing distances: comparison of two models of machine learning. Eur J Appl Physiol. 2017 Aug;117(8):1533-1555. doi: 10.1007/s00421-017-3630-0. Epub 2017 Jun 13.
- Results publication: PubMed 31217092Khreis S, Ge D, Rahman HA, Carrault G. Breathing Rate Estimation Using Kalman Smoother With Electrocardiogram and Photoplethysmogram. IEEE Trans Biomed Eng. 2020 Mar;67(3):893-904. doi: 10.1109/TBME.2019.2923448. Epub 2019 Jun 17.
- 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.
Carre François, MD principal investigator
University of Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensors in people with Physical Activity, run by Rennes University Hospital at 1 site in France.
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 8 inclusion and 5 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 24 May 2023. 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 France. 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?
asses the continuous acquisition of data by sensors (time frame: every day (during 3 weeks)). 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 NCT03673189, which also lists 3 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 24 May 2023.