Sensors for HEalth Recording and Physical Activity Monitoring

Physical Activity Clinical Trial

— SHERPAM  

Official title:

Sensors for HEalth Recording and Physical Activity Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673189
• Other study ID #: 35RC17_8836
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: September 12, 2019

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: 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.

Related Conditions & MeSH terms

• Physical Activity

Intervention

Device:
• sensors
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.

Locations

Country	Name	City	State
France	Unité de Biologie et médecine du Sport	Rennes	Bretagne

Sponsors (3)

Lead Sponsor	Collaborator
Rennes University Hospital	CIC-IT 14-14, LTSI-INSERM U1099

Country where clinical trial is conducted

France, 

References & Publications (3)

Dumond 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. — View Citation

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 — View Citation

Khreis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asses the continuous acquisition of data by sensors	transmission and reception of physiological parameters of a patient	every day (during 3 weeks)
Secondary	Test acceptability of SHERPAM Device	questionnary	after 7 days of use
Secondary	Test acceptability of Sherpam Device	questionnary	after 21 days of use
Secondary	Test usability of Sherpam Device	questionnary	after 7 days of use
Secondary	Test usability of Sherpam Device	questionnary	after 21 days of use